Happy New Year! 2015 BioClean Catalogue Available now

Transcription

A LOOK BACK AT 2014:
DESIGN & BUILD:
MICROBIOLOGY:
A review of the year’s major business
deals, new builds and product trends
A new future-proof manufacturing
facility for lenses shows clear vision
New discoveries and technologies
drive test practices and standards
THE INTERNATIONAL JOURNAL
OF CONTAMINATION CONTROL
January 2015
CLEANROOMTECHNOLOGY.COM
Happy New Year!
2015 BioClean Catalogue
Available now
Download fromwww.bioclean.com
or to request a copy please email
[email protected]
CONTAMINATION CONTROL
Hands Up If You’re Ready!
Uncompromising. That sums up the new regulations and guidelines
coming into force, requiring pharmaceutical manufacturers to have an
implementation strategy in place.
A number of recent guidelines from the MHRA
and the Pharmaceutical Inspection Cooperation
Scheme, along with proposed changes to EU
guidelines for GMP, represent a shift in regulatory
expectations for cleanroom facilities.
The new recommendations include adding
a sporicidal agent to current ‘spraying in’ 1
procedures, and support the use both of
endotoxin tested products and a closed dispensing
system 2 for disinfectants in cleanrooms to
minimise risk.
Fortunately, Ecolab’s expert team won’t
compromise on contamination control either
and can use all their expertise to help your
facility prepare with a full range of products
and services that directly addresses these
requirements. Aside from a fully validated
product range, Ecolab offer SiteCheck - the free,
no obligation site review service - and the DDE
system - to establish disinfection best practice.
So with Ecolab, you’re always ready.
TO FIND OUT HOW WE CAN HELP CONTROL CONTAMINATION IN YOUR FACILITY,
PLEASE CONTACT YOUR ECOLAB CONTAMINATION CONTROL EXPERT,
EMAIL US AT [email protected] OR CALL +44 (0)2920 854 390
USE BIOCIDES SAFELY. ALWAYS READ THE LABEL AND PRODUCT INFORMATION BEFORE USE.
ECOLAB CONTAMINATION CONTROL
Brunel Way
Baglan Energy Park
Neath SA11 2GA UK
02920 854 390 (UK)
+44 2920 854 395 (Export)
New regulations are not just affecting you but
they are coming into force for your cleanroom
products supplier - see page 6 for details.
At Ecolab Contamination Control,
we are ready… is your supplier?
www.ecolabcc.com
© Ecolab 2014 6869/12.14
1. PI 007-6 PIC/S
2. MHRA Guidance for MS Holders Version 1, App 2, Sec 3. 5.20
Our unrivalled range of alcohol &
biocide sprays all feature our unique
SteriShield Delivery System (SDS).
As the only fully validated trigger
spray system compliant with the
new MHRA guidelines, the SDS can
further reduce the possibility of risk.
Visit ecolabcc.com for more details.
WITHOUT COMPROMISE
January 2015
3
contents
January 2015 Volume 23 Number 1
Managing Editor Hilary Ayshford
[email protected]
+44 20 7193 4338
Deputy Editor Susan Birks
[email protected]
+44 20 7193 9012
Associate Editor Jane Ellis
[email protected]
+44 20 7193 9383
Art Editor Sibylla Duffy
[email protected]
+44 20 7193 8253
Sales Manager Ali Badr
[email protected]
+44 20 7193 6654
Sales Representative Mo Malik
[email protected]
+442071932139
Managing Director Colin Bailey-Wood
[email protected]
+44 20 7193 6066
Production Director
Erika Hatva
[email protected]
+44 20 7193 9279
NEWS
FEATURES
REGULARS
JV GIVES BOSCH FOOT IN
INDIAN PHARMA SECTOR 5
Bosch has taken a 49% stake in
a supplier of pharma-based
cleanroom technology
2014 – A YEAR OF M&A
ACTIVITY AND EXPANSION 25
A brief review of moves and
acquisitions in the controlled
environment sector
EDITORIAL 5
INDUSTRY NEWS 5
PEOPLE 16
EVENTS 20
WEB WINDOWS 70
MARKETPLACE 71
LABEL PRODUCER OPENS
ISO 8 FACILITY IN WALES 8
Essentra’s plant will produce
foils for healthcare markets
DESIGN TRENDS AND
CLEANROOM PROJECTS 33
Highlights of the most
prestigious new facilities and
build concepts of 2014
VETTER COMPLETES THIRD
SYRINGE CLEANROOM 12
The German CDMO has
expanded its Chicago syringefilling facility
Digital Production Nita Salem
[email protected]
Subscriptions Julie Wilson
[email protected]
+44 20 7193 1279
Published by
HPCi Media Limited
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Vogans Mill Wharf
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UK
CLEANING CHEMICALS TO
SEE 4% GROWTH 16
Industrial cleaning chemicals
use set to rise, largely due to
growing healthcare demand
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The paper used within this publication is
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obtained from manufacturers who operate
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HOHENSTEIN HAS NEW ESD
GOWN LAUNDERING TEST 20
Laundries will be able to certify
that their ESD clothing life has
been extended
A LIFE SCIENCE FACILITY
BUILT WITH VISION 40
Morgan Sindall describes the
build of a new facility for intraocular lens manufacture
PRODUCT TRENDS IN PPE
AND TEXTILES 47
Antimicrobial textile standards,
sustainability and greater
comfort are the main focus
CONTAINMENT FOCUSES ON
BETTER PROTECTION 53
Demands for greater personnel
protection are combined with
production speed and flexibility
IMPROVING THE
DISINFECTION ARMOURY 60
2014 saw many advances in
disinfection technologies and
products
ISSN: 1365-5531. ©2015.
All rights reserved. No part of this
publication may be reproduced or
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electronic or mechanical including
photocopying, recording or retrieval system
without the express prior written consent of
the publisher.
The contents of Cleanroom Technology are
subject to reproduction storage and retrieval
systems.
NEW IDEAS FOR CLEANROOM
MICROBIOLOGY 66
Pharmig highlights the gap
between current standards and
regulator expectations for
testing and monitoring
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Left to right, above: GEA has
supplied Zydus Cadila with a
complete oncology manufacturing
line page 5; Morgan Sindall
builds a new life science facility
for Rayner page 40; New copper
fittings are being used to reduce
the spread of HAIs in hospitals
page 60
A LOOK BACK AT 2014:
DESIGN & BUILD:
A review of the year’s major business
deals, new builds and product trends
A new future-proof manufacturing
facility for lenses shows clear vision
MICROBIOLOGY:
New discoveries and technologies
drive test practices and standards
January 2015
Happy New Year!
2015 BioClean Catalogue
Available now
Download fromwww.bioclean.com
or to request a copy please email
[email protected]
THIS MONTH’S
COVER
BioClean’s Magnificent 7
celebrates the launch of the
second edition of the BioClean
Cleanroom Product Catalogue.
For your copy email
[email protected] or visit
www.bioclean.com
Minton Enterprise Park
Oaks Drive
Newmarket
Suffolk CB8 7YY
UK
T +44 1638 663338
[email protected]
www.bioclean.com
THEY SAID IT
COULDN’T BE DONE.
running the
Four minute mile
6 May 1954
man landing
on the moon
20 July 1969
birth of the first
test tube baby
Irradiation of H2 02
25 July 1978
29 august 2013
CONTEC HYDROPURE
THE WORLD’S FIRST
IRRADIATED H202 PRODUCT.
Contec are delighted to introduce Sterile HydroPure, a 6% stabilised
hydrogen peroxide solution blended with Water for Injection (EP).
With a guaranteed low level of endotoxins, 0.25 EU/ml, Contec
HydroPure is the only hydrogen peroxide solution to be terminally
sterilised. Triple bagged and manufactured using the highest grade
of hydrogen peroxide, HydroPure leaves no residue so is especially
suitable for product contact areas. To find out more about Contec
HydroPure and other exciting developments in the Contec range;
contact Contec at
[email protected] or by
calling 0845 652 2582
to request a sample.
www.contecinc.com
Use biocides safely. Always read the label and product information before use.
January 2015
5
industry news
Noxilizer expands
contract sterilisation
operations
Noxilizer, a US specialist
in room-temperature,
nitrogen dioxide (NO2)
based sterilisation for life
science manufacturers,
has expanded its
operations following
growing customer
demand and increased
industry acceptance of
the company’s NO2
sterilisation technology.
‘Manufacturers have
quickly recognised the
advantages of NO2. This
expansion was mandated
by a significant increase
in customer feasibility
studies alongside
work,’ said Maura Kahn,
VP, Business
Development &
Marketing at the
Baltimore-based
company.
NO2 sterilisation is
gaining recognition as an
alternative for pressure
and temperaturesensitive products.
The company says
NO2 is safe and simple to
use. It sterilises with or
without a vacuum and is
effective at low humidity
levels.
In addition, Noxilizer
services may provide
cost savings to
manufacturers with a fast
turnaround of product.
Cycle times are notably
shorter, as lengthy
preconditioning and
post-exposure aeration
phases of the cycle are
eliminated with NO2.
In addition, packaged
sterile product can be
handled immediately
after the cycle, allowing it
to be returned to
inventory quickly.
Noxilizer’s 16,000ft2
facility, located within the
University of Maryland
BioPark in the US,
includes office,
laboratory,
manufacturing and
space.
www.noxilizer.com
BOSCH AND KLENZAIDS
PLAN JV IN INDIA
Bosch Packaging Technology is taking a 49% share
in Klenzaids Contamination Controls, an Indian
manufacturer of processing, packaging and
cleanroom technology for the pharma industry.
No financial details have been revealed, but the
two companies say the aim of the JV is to extend
their global reach, particularly in liquid
pharmaceuticals and packaging machines for
cleanroom environments. Klenzaids will contribute
its expertise in designing and building cleanrooms,
processing technologies and peripheral systems,
while Bosch will offer its strength in innovative
filling technologies.
Founded in 1978 and headquartered in Mumbai,
Klenzaids generated sales of approximately b6m in
2013 and employs 350 people. The company
supplies laboratories that meet biological safety
class standards 2–4. It also offers isolators and
processing technologies for the production of liquid
pharmaceuticals.
Bosch Packaging Technology, which last year
achieved global sales of b1.1bn and employs around
5,600 people worldwide, has been developing,
building and selling vertical and horizontal flow
wrapping machines for packaging food as well as
filling and sealing machines for liquid
pharmaceuticals at its plant in Verna in Goa, India,
since 2012. The company has since sold more than
1,500 packaging machines to leading brand
companies in the food and pharma industries.
The JV will be headquartered in Mumbai and is
expected to employ 380 people.
Friedbert Klefenz, President of Bosch Packaging
Technology, said: ‘We already have a long history of
trusted collaboration with Klenzaids. The company
is known for employing excellent people and for
providing high-quality products and services. I am
delighted at the prospect of a future together.’
Hamish Shahani, Managing Director of
Klenzaids, added: ‘Joining forces and pooling our
resources will give us a stronger starting position
in the emerging Indian market. Despite our
different regional backgrounds, Bosch and
Klenzaids have a lot in common.’
www.boschpackaging.com www.klenzaids.com
EDITORIAL
Help for those in the
battle against Ebola
Confirmed cases of Ebola in Africa have now
topped 20,000 with more than 7,000 deaths,
according to the World Health Organization
(WHO). Some 678 healthcare workers are also
known to have been infected, 382 of whom have
died. While the situation is far better managed
than in the early stages, the region is still in
desperate need of outside help.
Ebola is classified by the WHO as a Risk Group
4 pathogen, requiring Biosafety level 4-equivalent
containment precautions. Hard lessons are being
learned about the difficulties of achieving this in
the field in this impoverished region. Simple
equipment, widely available in the West, is hard to
come by in the quantities required in these
isolated regions of Africa. The National Ebola
Response Cell of Guinea has said it needs more
than 5.6 million pairs of surgical gloves for its
healthcare facilities, for example.
The situation has highlighted other difficulties:
the West is used to operating in pressurised
isolation units within brick-built hospitals, where
the latest disinfectant vapour technology can be
deployed, but how do you disinfect a canvasbased field hospital?
It is also apparent that current PPE is not ideal
for the high humidity and heat, nor is it easy to
remove without touching the outside.
However, disaster can be a catalyst for
invention and new solutions are being developed.
An advanced protective suit for Ebola healthcare
workers has been devised by a Johns Hopkins
team, in a federal funding contest set up to help
combat the deadly disease. Its enhancements
include a large visor integrated into the suit, air
vents and a small battery-powered cooling device
for the hood, a rear zipper and a novel noncontact doffing process.
Canadian company Design Shelter has also
developed mobile hospital units that have an inbuilt specialised HVAC unit to control internal
pressure and allow the use of disinfection
technology.
Great ideas, but much more needs to be done
to help those in the grip of this terrifying disease.
SUSAN BIRKS
DEPUTY EDITOR
GEA SUPPLIES HIGH CONTAINMENT DRUG FACILITY TO ZYDUS CADILA
company in India, chose
GEA has supplied Zydus
fully equipped UltimaPro 10
Cadila, a fully integrated,
and 75 single pot
global healthcare provider,
processors, Hicoflex
with a complete oncology
technology and BUCK MC
manufacturing line as part
valves from GEA to ensure
of the Indian company’s
that it will be able to
plan to upgrade its solid
produce its OEB 3 and 4
oral dosage form
GEA has supplied Zydus Cadila with a complete
oncology manufacturing line
drugs in a safe, cGMPproduction processes for
compliant environment and
potent drugs.
guarantee maximum yields with reduced cycle
Ahmedabad-based Zydus Cadila, which is the
times. www.gea-ps.com www.zyduscadila.com
fifth largest pharmaceutical manufacturing
By The Book
You can take it as read that, at Ecolab, our regulatory department constantly
monitors the latest industry regulations to ensure that our products and
processes are always compliant.
As market leaders in contamination control we are
always looking to the future, and that means planning
for the latest advice from relevant regulatory bodies.
Recently, we’ve been making changes to the way we
register and label our products to adhere to the most up
to date advice from the EU.
The Biocidal Products Regulations’ (BPR) authorized
list of active substances acceptable for use in biocides
requires products to be registered with the European
Chemicals Agency (ECHA). The consequences of noncompliance are disruptive and expensive; continuity
of supply may be compromised when an unauthorized
product is removed from the market, causing production
disruption, downtime, and urgent change control and
validation to implement a replacement. You may also be
fined if you use a unauthorized product as a biocide.
By using Ecolab’s products, you are assured that
you are using products that will be supported through
the BPR. Importantly, this legislation also applies to
pharmaceutical companies manufacturing their own
biocide for internal use. If it’s not registered according to
BPR, it’s not valid for use as such.
Additionally we are making changes to our product
labels in accordance with the Classification Labeling
and Packaging Regulation (CLP), ensuring any hazards
associated with the use of our products are clearly
indicated in line with new global standards. We also
register our products under the REACH directive1 to
ensure the highest level of safety for users and
the environment.
Our products are always up to date with the latest
regulatory requirements, so you can use them with
absolute confidence. Are you sure other suppliers can
say the same?
TO FIND OUT HOW WE CAN HELP CONTROL CONTAMINATION IN YOUR FACILITY,
PLEASE CONTACT YOUR ECOLAB CONTAMINATION CONTROL EXPERT,
EMAIL US AT [email protected] OR CALL +44 (0)2920 854 390
ECOLAB CONTAMINATION CONTROL
Brunel Way
Baglan Energy Park
Neath SA11 2GA UK
02920 854 390 (UK)
+44 2920 854 395 (Export)
Our commitment to remaining compliant,
and helping you do the same, means that
with Ecolab you’re always ready. See page 2
for how we can help you prepare.
www.ecolabcc.com
USE BIOCIDES SAFELY. ALWAYS READ THE LABEL
AND PRODUCT INFORMATION BEFORE USE.
© 2014 Ecolab All rights reserved 6689.1/12.14
1. Registration, Evaluation, Authorization and Restriction of Chemicals
2. MHRA Guidance for MS Holders Version 1, App 2, Sec 3. 5.20
Our unrivalled range of alcohol &
biocide sprays all feature our unique
SteriShield Delivery System (SDS).
As the only fully validated trigger
spray system compliant with the
new MHRA guidelines2, the SDS can
further reduce the possibility of risk.
Visit ecolabcc.com for more details.
WITHOUT COMPROMISE
Be prepared for changes to
pharmaceutical industry regulations
Ecolab Contamination Control, a worldwide provider of leading products and services for the control
of microbial contamination in the cleanroom environment, informs the pharmaceutical industry about
a wide range of regulations with major compliance implications, beginning to come into force.
For an industry which is generally risk averse new
regulation changes will challenge current protocols like
never before, meaning companies need to be proactive
to avoid the consequences of non-compliance.
The Biocidal Products Regulation (BPR) which
succeeded the Biocidal Products Directive (BPD),
removing the ability for country interpretation, on
1 September 2013 is among the regulations which
Ecolab Contamination Control has highlighted.
These changes are aimed at ensuring a high level
of protection of human health
and the environment. They
also address the simplification
and harmonization of the
authorization procedures
necessary to allow a company to
market a biocide product for use
across the EU.
To ensure compliance, the
BPR’s authorized list of active
substances acceptable for use
in biocides requires products
to be registered with the European Chemicals
Agency (ECHA).
Central to these new regulations is that biocidal
products should neither be made available on the
market nor used unless authorized. This also applies
to the purchase of raw materials with the intention of
using them to biocidal effect, in-house.
The regulations apply to every manufacturer and
mean that only products containing an approved
active substance can be marketed legally. Failure
to comply could incur fines and possible criminal
proceedings for the manufacturer and end user.
Additionally, consideration should be given
to market impact if the product can no longer be
supplied. Ecolab Contamination Control is supporting
its core range of biocides through the BPR with its
regulatory department and is acting as a leader within
consortia supporting the submission of actives.
*The EPA Establishment Registration number is 001677-GBR-001.
Ecolab Contamination Control also has
EPA Establishment Registration* as part of the
registration process under different authorities. The
manufacturing facility is an EPA registered facility,
ensuring quality and continuity of supply for
its customers.
Meanwhile, Ecolab Contamination Control is
advising manufactures and importers of chemicals
into the EU to review compliance with the European
Union’s Registration, Evaluation, Authorisation and
Restriction of Chemicals (REACH).
REACH requires these companies to assess the
health and environmental risks associated with the use
of chemicals and take the appropriate steps to manage
these effectively.
Ecolab Contamination Control pre-registers every
chemical it synthesizes or imports under the REACH
directive, to protect customers and the environment
from any potential hazards resulting from their use.
Any active ingredient registered with the Biocidal
Products Regulation (BPR) is part of the authorized
list of active substances,
acceptable for use in biocides
from the BPR. The non-active
ingredients used in biocides
are registered under REACH.
James Tucker, Marketing
Director at Ecolab
Contamination Control
says: ‘We continue to ensure
compliance for all our
substances and products and
recommend other companies do the same.
‘As part of this we are continually in
contact with our suppliers, especially those who
manufacture our raw materials to ensure the
continued availability of the substances used in our
existing products and future innovations.
‘We also work with suppliers to make sure that
the substances we use are covered by their REACH
registration dossiers, chemical safety reports and
Safety Data Sheets’.
In order to fully comply with all the latest industry
regulations Ecolab Contamination Control has
invested more than US$1 million to date, with this
expected to rise steadily over the coming years and
employs a dedicated team of professionals.
Not only does that mean customers have complete
peace of mind, but it keeps Ecolab Contamination
Control at the forefront of delivering contamination
without compromise, allowing its customers to focus
on their own production.
For contamination control without compromise, talk to Ecolab Contamination Control.
For further information or to request a site visit, please contact your Ecolab Contamination Control
Expert or call customer service on 02920 854 390 or +44 (0) 2920 854 395 (Export)
Ecolab Contamination Control, Brunel Way, Baglan Energy Park, Neath SA11 2GA UK
Product packaging and
labelling set for change
New regulations relating to the packaging
and labelling of products, as part of the new
European Legislation for Classification,
Labelling and Packaging of chemical
substance and mixtures (CLP), are also set
to be introduced.
This is based on the UN’s Globally
Harmonized System of Classification and
Labelling of Chemicals (GHS), which aims
to standardise the labelling of products
worldwide and make their safe use more
straightforward.
Although substances have needed to be
classified and labelled according to CLP
in the EU since late 2010, from 1 June
2015 formulations or mixtures will also
need to be classified in the EU according
to CLP regulations. Some classification
of products will change, however Ecolab
Contamination Control will not be changing
any formulations because of CLP.
The update will include amended graphical
representations (pictograms) of the type of
hazard that a chemical product is classified
as, the use of two signal words (Danger and
Warning) and both hazard and precautionary
statements.
‘The cleanroom disinfectant manufacturers
have been working towards the 2015 deadline
for some time, with no penalty being
imposed for lack of compliance’, says Mr
Tucker. ‘From this year that is
all going to change and the
industry needs to be ready.
Put simply, if a customer
purchases an unsupported
or non-compliant product,
they may be forced to make a
change, meaning the product
in use would not be validated
and could result in their
production lines ceasing.’
8
January 2015
industry news
ESSENTRA OPENS PURPOSE-BUILT LABELS AND
MANUFACTURING FACILITY IN NEWPORT, WALES
gained the triple certification
Essentra has officially
of ISO 9001, ISO 14001 and
opened its labels
OHSAS, as well as the
manufacturing facility in
BRC/IoP global standard for
Newport, Wales, which
packaging and packaging
provides the company with a
materials.
52,000ft2 facility from where
The new facility was
it can meet the growing
opened by Essentra’s
demands of existing and new
Chairman Jeff Harris and
customers.
CEO Colin Day in front of
This latest investment
Economy Minister Edwina Hart (centre) officially
employees and Economy
follows the announcement
opens the Newport facility
Minister Edwina Hart from
that the company is to
the Welsh Government, which provided £290,000 of
acquire Clondalkin Group’s Specialist Packaging
finance for the project. The site currently employs
Division for around US$455m.
66 people and has plans for further expansion.
The Newport site incorporates Essentra’s latest
Harris said: ‘Our Essentra facility at Newport
investment in digital printing and a cleanroom for
represents a substantial investment in our label
production of primary packaging foils for the
and primary packaging capabilities, and ensures we
healthcare market. To ensure the exacting
have the best operational footprint and necessary
requirements of this market are met, the
space to meet the growing needs of the healthcare
cleanroom meets Class 8 ISO standards and is the
and consumer packaging markets we serve.’
first for Essentra. The factory also meets
Essentra’s internal standards for quality, and has
www.essentra.com
Steriliser energy recovery
concept provides cost savings
With a new patented energy recovery concept for
hot water shower sterilisers, Bosch enables users
to achieve significant energy savings in heating
and cooling during the sterilisation process.
The concept was developed by Bosch company
Schoeller-Bleckmann Medizintechnik (SBM). SBM’s
hot water shower sterilisers are used in the pharma
industry for the sterilisation of liquids in 100%
sealed containers, such as vials.
The self-contained, independent system consists
of a multilayer water storage tank, which is divided
into several temperature zones and piped to the
steriliser via a heat exchanger. The water
temperature in the permanently filled storage tank
increases from bottom to top. Separation planes
prevent the temperature zones from mixing too
quickly.
The water temperature of the sterilisation phase
is usually 121°C. During cooling, the hot process
water flows through the heat exchanger, where it is
cooled by cold water from the storage tank. The
water in the storage tank thereby absorbs energy
from the steriliser, and heats up again. By using
existing cold water from the multilayer storage,
manufacturers can reduce the amount of additional
and costly cooling medium. After the steriliser has
been reloaded, the energy in the multilayer storage
can be re-used to heat the process water to 121°C.
A continuous repetition of these steps reduces
the required amounts of heating and cooling
media. As a result, up to 40% of the initial heating
energy can be saved. Thanks to an additional
heating exchanger in the storage tank, the saving
potential amounts to 60%. www.bosch.com
CHINESE LAUNDRY SERVICE AWARDED
RAL QUALITY CERTIFICATION
Jesse Healthcare
Linen Services, in
Shanghai, has
become the first
laundry service in
China to be awarded
the RAL Quality
Certification Mark
992 for Professional
Textile Services
(RAL-GZ 992). Dr
Andreas Schmidt,
Compliance with the standard
from the Hohenstein
is regularly checked on site by
Institute in
experts from the Hohenstein
Institute.
Bönnigheim,
Picture: Hohenstein Institute
Germany, presented
the certificate to Zheng Yongxiang, Director of
Jesse Healthcare Linen Services and his team.
For Yongxiang, proven and certified safety with
regard to quality and hygiene was seen as
particularly crucial: ‘The provision of proper
hygienic textiles is the top priority for our industry.
Our customers can rest assured that our laundry
consistently satisfies the highest international
quality and environmental requirements. The
proven and certified safety guidelines mark us out
from other service providers and can thus help us
to build on our position.’
The Quality Certification Mark is exclusively
awarded by the Gütegemeinschaft sachgemäße
Wäschepflege (German Certification Association for
Professional Textile Services), which is also located
in Bönnigheim. www.hohenstein.de
New heat sealer from
Nelipak
Dutch medical
thermoforming specialist
Nelipak Healthcare
Packaging has launched
a tabletop tray heat
sealer, used for
packaging items in
Class 7 cleanroom
environments.
Manufactured in
stainless steel for ease
of cleaning, the NX-T1
machine is easy to use
and requires little
maintenance.
The heat sealer
features a ‘hands-free’
sealing system, which
automatically closes to
begin a sealing process
and opens when this is
complete, reducing the
risk of contamination. It
also features new
software, including an
upgraded Siemens PLC
HDMI Controller.
The NX-T1 includes a
function that allows the
user to ensure the
correct tool set – the
tools inside the machine
used to finish the trim of
the package – is selected
in combination with a
particular recipe of
plastics needed for the
package. If the wrong
combination is selected,
the machine
automatically locks up.
www.nelipak.com
bioMérieux launches
3P culture media for
cleanrooms and
isolators
bioMérieux Industry has
added 3P, a new culture
media for cleanroom and
isolator use, to its
portfolio.
3P was tested for
growth promotion from a
library of 100+
organisms, including
USP strains and wild
plant isolates. It was
developed with an
innovative packaging
system to manage
moisture content in the
product. It enables
storage from 2 – 25°C.
www.biomerieuxindustry.com
Profile - Cleanroom Leasing
INTERNATIONAL EXPERT:
CLEANROOM LEASING
SERVICE
The preparation of cleanroom
clothing requires expert knowledge
that only a few suppliers possess.
CWS-boco has been relying on its
international experience in the
cleanroom clothing segment for
over two decades already. CWSboco operates its own cleanroom
laundries in Germany, Ireland,
Poland, Belgium and China and, as
such, is ideally placed to serve this
segment.
The company services a wide
range of industries including the
microelectronic, automotive and
pharmaceutical sectors as well as
biotechnology and many others.
CWS-boco offers textile laundering
for the pharmaceutical grades A to
D and ISO classes 4 to 9 depending
on the country in question.
The Helmke drum test
CWS-boco employee in Cleanroom
with decontaminated clothes
It is all about quality and reliability
The quality assurance, testing
methods and compliance with
standards are continuously
redefined in order to satisfy the
most stringent international
requirements. In this way, for
example, certified reprocessing is
conducted under cleanroom
conditions as per EN ISO 14644. The
cleanroom expert uses disinfection
and validated washing methods to
ensure consistent washing
standards. Various items of clothing
are recorded individually by means
of electronic inventory management
and can therefore be allocated to
the specific wearer. CWS-boco
documents all the processes and
handling steps. In addition, it
performs quality management as per
DIN EN ISO 9001:2008 including
laboratory tests.
Profile - Cleanroom Leasing
The boco cleanroom line
Its state-of-the-art cleanroom
laundries allow CWS-boco to
provide a full service encompassing
all aspects of cleanroom clothing.
The specially trained experts are on
hand to provide customers
professional and tailored advice.
CWS-boco offers a diverse range of
standard cleanroom clothing in the
quality for which CWS-boco has
become synonymous. Smooth
surfaces help to reduce wear, all
itemscan be completely
decontaminated and sterilised,
there is no build-up of electrostatic
charges due to integrated carbon
fibres and the outstanding
resilience of the clothing means a
long service life is guaranteed. The
clothing is delivered to customers in
individual contamination-protected
packaging, on request with
sterilisation, in a transport
container.
Sustainability matters
At CWS-boco sustainability is a
central part of the company’s
strategic alignment. According to
the CWS-boco business model, the
improvement of economic success
and sustainability go hand in hand.
The focus here is on environmentally
friendly manufacturing, consumption
and disposal as well as reusable
products in terms of both product
development and material
procurement. The delivery,
processing and decontamination of
reusable cleanroom clothing offers a
cost-effective and environmentally
friendly solution to all cleanroom
requirements – from the design to
the delivery.
The service circle of CWS-boco
Spiddal | Irland
Puurs | Belgien
Shanghai | China
Heidenheim | Deutschland
Międzyrzecz | Polen
CONTACT
CWS-boco International GmbH
Dreieich Plaza 1 B, 63303 Dreieich
● Tel +49 (0) 6103 309-0
● www.cws-boco.com
The CWS-boco cleanroom laundries
12
January 2015
industry news
LOTUS PRO CLEANING SYSTEM TRANSFORMS TAP
WATER INTO A POWERFUL CLEANING PRODUCT
Green World Innovations, a specialist in
disinfecting and sanitising using ozone-based
products, has launched the lotus PRO cleaning
solution in the UK market. The company is the
exclusive partner for Tersano, the Canadian
manufacturer of the product.
Suitable for industrial cleaning, the lotus PRO
transforms water into aqueous ozone by infusing it
with ozone, which the unit can efficiently stabilise
for up to 24 hours. The infused water is chemicalfree and a viable alternative to potentially harmful
chemical cleaning products. It can be used to clean
before changing safely back into ordinary water
and oxygen, reducing the impact on employees and
the environment, the company says.
Capable of producing a continuous flow of
approximately 14 litres of aqueous ozone/minute
using the equivalent power of just two 40W
lightbulbs, the system provides a residue-free
cleaner that offers a longer-lasting clean. As well as
eliminating pathogens, grime and grease, the
solution does not use any toxic chemicals, which
Purite improves laboratory
efficiency with Integra 200E
The Integra 200E high performance ‘plug and play’
water purification system from Purite, a UK
designer and manufacturer of advanced water
purification systems, delivers laboratory grade
water up to 15 M1.cm, while minimising installation
and servicing times.
The unit provides laboratories with reverse
osmosis, electro-deionisation, ultra-violet
irradiation and bacterial microfiltration technology
to supply users with optimum efficiency and
flexibility in the water purification process. The
system is configured and tested before delivery to
minimise installation times.
Variable speed pumps are installed to ensure
that laboratories can keep their energy
consumption to a minimum, while category 5
backflow prevention technology offers protection
to the mains supply.
The Integra 200E unit is said to be easy to use,
and features a comprehensive control system
complemented by a colour LCD touch screen.
Added security is provided through a password
access menu and a semi-automated chemical
cleaning programme. It has a make-up flow rate of
200 litres per hour and users can choose storage
tank options to suit different needs, including 350,
500 and 1,000 litres.
Enhancing efficiency and safety further, the
Integra 200E is supplied with an in-built automatic
alarm system that monitors any leakage and quality
of the purified water. If this detects a leak or a
reduction in water quality a notification is sent to
alert users that there might be a problem.
www.purite.com
means there are no hazards from splashing or
fumes, or skin or eye irritation. It also improves
productivity since no rinsing is required compared
with other chemical cleaners on the market.
With a track record in Canada – where the
solution was first launched five years ago – the
lotus PRO can cut cleaning costs by up to 50%.
Martin Booth, Managing Director of Green World
Innovations, said: ‘We are very excited to bring the
lotus PRO technology to the UK market as a
proven and powerful chemical-free cleaning
alternative. Aqueous ozone technology is not only
improving the quality of work for employees but is
also helping to reduce costs and improve
productivity.’
The solution has been tested and certified under
strict regulatory requirements. It has also been
tested and recognised as an effective cleaning
solution, meeting the Green Seal Environmental
Standard (GS-37) for performance as an industrial
cleaner.
www.gw-com.com
VETTER ADDS THIRD CLEANROOM IN
CHICAGO FOR SYRINGE PROJECTS
Vetter, a specialist in
aseptic filling, has
completed the next
stage of the
expansion of its US
development site on
the Illinois Science
+ Technology Park
in Chicago, with the
addition of a third
cleanroom.
Clinical syringe
projects are now
being accepted at the German CDMO Vetter adds a
facility, which can
third cleanroom in Chicago
handle preclinical to
Phase II projects. The overall 3,000m2 site offers all
of the resources needed for early-stage clinical
manufacturing, including chemical analysis and
microbiology labs, material preparation and
compounding functions. At the heart of the facility
are its three cleanrooms, together with visual
inspection capabilities and GMP storage.
With the addition of the third cleanroom, filling
of single-chamber syringes is now available at a
maximum filling speed of 3,600 units/hour, and
batch sizes up to 25,000 units. The line is
constructed as a Restricted Access Barrier System
(RABS), offering various filling pumps, as well as
fully automated tub processing.
The two existing cleanrooms, operational since
2011, provide fully automated vial filling.
www.vetter-pharma.com
Sartorius adds
BIOSTAT Cplus lab
bioreactor for process
development to
portfolio
Sartorius Stedim
Biotech’s BIOSTAT Cplus
stainless steel
fermenter/bioreactor is
for the cultivation of
micro-organisms and cell
cultures. Typical
applications include
process development for
the production of
biopharmaceuticals,
vaccines, biofuels and
secondary metabolites,
the optimisation of batch,
fed-batch, continuous
and perfusion processes,
as well as scale-up
and scale-down
experiments.
The Sterilisable-InPlace (SIP) system is
equipped with a DCU
controller and other
functions such as
gravimetric feed control,
advanced DO controller
and integrated off-gas
measurement. The
culture vessels are
supplied with operating
volumes of 5, 10, 15, 20
and 30 litres.
The BIOSTAT Cplus
features a modular
design that allows for
individual system
configuration to meet
specific requirements.
For example, additional
functions are available,
such as automatic
pressure control, as well
as re-sterilisable valves
and sterile sampling kits.
The culture vessel can
be sterilised with electro
or steam heating, which
allows the fermenter/
bioreactor to be
integrated into existing
infrastructure easily.
The compact design
saves valuable
laboratory space; rollers
under the supply unit
ensure mobility and
allow the system to be
moved around to other
labs while offering easy,
unimpeded access to
permit the floor
underneath to be
cleaned.
www.sartorius.com
We just get
Beta and Beta
Micronclean’s revolutionary, non-corrosive
sporicide, Beta, is just the latest innovation
in our continued development of cleanroom
solutions over the past 34 years.
Our history, however, dates back to 1883
as the Skegness Steam Laundry providing
a service to the hotels and boarding
houses which were rapidly being built in
the area.
During the 1970s, the Company changed
to specialist suppliers of clean garments
to the food processing and manufacturing
industries.
In 1981 Micronclean designed and
patented a processing system for
garments which were to be worn in
Class 10 (ISO 4) and Class 100 (ISO 5)
Cleanrooms. Three Micronclean plants
now provide specialised cleanroom
#"! """
!#"
#""
Skegness Class 4, Louth Class 6, and
Grantham Class 8.
In September 1987 the Company
"#"!
"
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Management System BS 5750 (now BS
EN ISO 9001:2008) for its process and
garment rental operation and in 1996 the
" "#"!
achieve BS 7750 (now ISO 14001) for its
environmental management systems.
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In February 1997 a brand new cleanroom
laundry was opened in Skegness
demonstrating the company’s
commitment to the cleanroom industry.
This ISO 4 (GMP Grade B) cleanroom
laundry uses a high purity Reverse
Osmosis water system and has a fully
computerised tracking system.
In 2013, Micronclean acquired Guardline
Technology to expand its cleanroom
!"#
#" dedicated R&D team continues to build on
this range with innovative new products,
and there are a number of exciting
projects in the pipeline that will be released
to the market during 2015.
In April 2003 a state-of-the-art facility was
opened in Louth, validated to ISO 6 early
in 2004. This facility remains the most
technically advanced Class 6 laundry in
Europe.
The company now has approximately 300
employees, three processing sites and
three dedicated regional delivery hubs.
We are proud to supply a diverse range of
!""
!
sectors.
During 2007, Micronclean became
registered to ISO 13485, the Medical
Device standard, and launched a range of
sterile medical devices.
In 2011 the company opened an ISO 5
cleanroom to manufacture a range of
consumable products used in cleanrooms
" ""##
safe cleanroom dosing of alcohol
into cleanroom trigger sprays and
impregnated wipes.
Micronclean continues to live up to
its reputation as one of the most
forward-thinking and innovative textile
leasing, consumable and medical device
" "
some things at Micronclean that will never
change: the principles of quality, customer
care and service upon which the company
was founded and which are as important
today as they have always been.
There’s a Beta
solution for all your
cleanroom needs
Non-Corrosive
Independently tested and approved
Sporicidal Action
Tested in accordance with EN 13704
Extensive Validation
Including independent Phase III
Microbiological validation in a life
science cleanroom facility
Available Formats
500ml Trigger Sprays, Wipes, Mops,
5ltr Container, Single Unit Dose
Encapsulated Irradiation
Indicator
No paper, no ink present
Transparent Bottle
Contents visually obvious
Ask for details of
our Alpha biocide
and complementary
Beta sporicide, broad
spectrum trigger sprays.
Quality
Qualit
ty Inno
Innovative
vativve S
Solutions
olutions
Roman
Roman Bank,
Bank, Skegness
Skegness,, Linc
Lincolnshire
olnshire PE25 1SQ.
Tel:
767377. Fax:
Fax: 0845 2992
2992166
166
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e
el: 01754
01754 767377.
Email: enquiries@micr
[email protected]
onclean.co.uk
Web: www
www.micronclean.co.uk
w..micronclean.co.uk
Garments & M
Mops
ops website
Web: www
www.micronclean.eu
w..micronclean.eu
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Consumables
onsumables website
ISO 14001
EN 14065
ISO 9001
ISO 13485
16
January 2015
industry news
GLOBAL DEMAND FOR INDUSTRIAL & INSTITUTIONAL
CLEANING CHEMICALS TO REACH US$46.3BN IN 2018
The fastest growth in cleaning chemicals will occur
in the healthcare sector over the next four years
owing to a rise in the number of hospital stays and
concerns about healthcare-associated infections
(HAIs), according to a new report from the
Freedonia Group.
The World Industrial & Institutional (I&I)
Cleaning Chemicals study from the Cleveland, USbased market research firm predicts that world
demand for industrial and institutional (I&I)
cleaning chemicals will increase 4.3% a year to
US$46.3bn in 2018, stimulated by increasing
efforts to prevent the spread of disease in
healthcare and food and beverage manufacturing
applications. The manufacturing sector is expected
to be a significant source of growth, particularly in
developing economies, as rising incomes lead to
increased demand for processed food and beverage
products and a focus on improving cleaning
standards.
Greater use in healthcare applications will come
from ageing populations in Europe, North America,
Australia, China and Japan, as well as from rising
prosperity in many developing countries.
Disinfectant and sanitiser sales will be
particularly strong, as these products feature
heavily in strategies to prevent the spread of HAIs,
which is a major focus within the healthcare
industry, the study forecasts.
Strong growth in food and beverage
manufacturing will be another important driver of
I&I cleaning chemical demand. Increased processed
food and beverage production will reflect rising
consumption in developing countries due to
growing spending power and the continued
adoption of more Western-style eating habits.
General purpose cleaners will continue to make
up the largest share of I&I cleaning products and
experience healthy growth going forward, but the
nature of this growth will be complex, owing to a
number of factors. Market maturity in many
developed countries, as well as product substitution
in response to the marketing of targeted,
specialised cleaners is expected to restrain
advances. This will be balanced by gains in less
developed markets where formulated general
purpose cleaners are increasingly used in the place
of basic chemicals, and by the shift towards more
sustainable, cost effective, and user friendly (but
ultimately higher value) products in regions such as
the US, Western Europe and Japan.
PEOPLE
leading commercial
laundry and textile
business, has appointed
Scott Inglis, previously
Group Finance Director,
as Commercial Director.
Inglis joined the
business in 2012. He
was previously Finance
Director at Turriff
Contractors.
Lucy Renaut,
previously Financial
Controller, has been
appointed Finance
Director. She joined the
business in 2012 having
been Finance Manager at
May Gurney.
TROX UK hires new
Marketing
Co-ordinator
Alice Arnott has joined
TROX UK, a designer and
manufacturer of HVAC
and building services.
She comes to the
company from Lotus,
starting there in a client
liaison role and then
transferring to Lotus’s
engineering division as a
Marketing Executive.
www.troxuk.co.uk
CDC launches
facilities
management
business
Cleanroom Design and
Construction (CDC), a
Stourbridge, UK-based
business, has launched a
facilities management
division to service
growth in demand for its
maintenance services.
The new company will
be known as CDC
Facilities Management
and operate across all
sectors including retail
and commercial
premises, as well as
CDC’s core industries of
pharma, healthcare,
medical, aerospace and
automotive.
Director Carl Isakovic
(above) will head the
company, which also
includes Sean Gallimore
as Senior Maintenance
Engineer and Justin
Donoghue as Service
and Maintenance
Co-ordinator.
www.cleanroomdesign.co.
uk
Fishers Services
makes boardroom
appointments
Fishers Services
(Fishers), Scotland’s
www.freedoniagroup.com
www.fishersgroup.co.uk
Nitritex appoints
Frank Tamburello as
Commercial Director
Nitritex, a UK-based
manufacturer of
cleanroom consumables
marketed under the
BioClean brand, has
appointed Frank
Tamburello as its new
Commercial Director.
Tamburello joined
Nitritex in 2006 as
General Manager, having
previously been
Purchasing Director for
one of the largest UK
NHS suppliers. His
commercial and
management experience
spanning 30 years has
provided him with a
wealth of high-tech
cleanroom product
knowledge and
expertise.
www.nitritex.com
Connect 2
Cleanrooms adds
Senior Contracts
Manager
Connect 2 Cleanrooms, a
UK-based supplier of
modular cleanroom
solutions for critical
environments, has
appointed Mike Enright
as Senior Contracts
Manager to identify
opportunities to integrate
the Puracore panel
system into the
company’s modular
cleanroom range.
www.connect2cleanrooms.
com
Biosenta disinfectant
kills 100% of moulds,
fungi, bacteria and
viruses
Biosenta, a Canadian
developer of chemical
compounds for domestic
and industrial
applications using
nanotechnology, reports
that laboratory research
testing on the
physical/chemical
properties and efficacy of
its most advanced
household disinfectant
has found it to be
effective in killing 100%
of potentially deadly
moulds and fungi, and a
wide range of bacteria
and viruses, on hard
surfaces.
According to the US
Center for Disease
Control (CDC), the new
disinfectant, which has
yet to be given a name,
will kill Ebola and
Enterovirus D68. This is
based on laboratory tests
that prove the new
disinfectant kills the
Polio virus which is
similar in cell structure
to Ebola and Enterovirus
D68.
The new disinfectant
uses nanotechnology to
create compounds that
have a significantly lower
concentration of active
ingredients; this has
several benefits,
including a lower toxicity.
This lower toxicity means
that the new disinfectant
can be safely used in the
kitchen as well as the
bathroom and living
areas. The new
disinfectant is a safe and
powerful disinfectant and
cleaner, yet it is safe for
daily use.
Dene Rogers,
President and CEO of
Biosenta, based in
Toronto, said: ‘The new
disinfectant is one of
several new and
advanced formulations
that Biosenta will have
approved in the US and
Canada.
‘Other products will
include a hand sanitiser
and wipes.’
www.biosenta.com
When performance is critical look to Ardmac
for compliant cleanroom solutions
Ardmac is an international cleanroom construction company working with engineering
consultancies and clients to provide cleanroom environments for the Pharmaceutical,
Biotech, Micro-Electronic and Medical Device sectors.
To find out how we can help your business contact us at:
[email protected]
IRL: +353 1 894 8800 UK: +44 161 866 8086 BE: +32 1068 6520
www.ardmac.com
www.pmtgb.com
Accredited on site calibration
Particle Counters and Microbial Air Samplers
PMT (GB) Ltd. · Willow End Park · Malvern
Worcestershire WR13 6NN · UK ·
Phone: +44 1684 312950 · Fax: +44 1684 312969
e-Mail: [email protected] · www.pmtgb.com
PMT (GB) Ltd.· Willow End Park · Malvern· Worcestershire WR13 6NN · UK· Phone: +44 1684 312950 · Fax: +44 1684 312969· e-Mail: [email protected] · www.pmtgb.com
Profile - Consumables
CONTEC LAUNCH RANGE OF
CLEANROOM DISINFECTANTS
Contec, a leading manufacturer of
contamination control products for
critical cleaning and disinfection in life
science manufacturing environments
worldwide, have added sterile and filtered
disinfectants to their range. With more
than 25 years of experience we
understand the unique cleaning
requirements of this specialist market
and are uniquely placed to help
customers find or create a Contec
product that best meets their needs.
Contec’s extensive existing product range
for life science and electronic
cleanrooms, includes sterile and nonsterile, knitted and non-woven dry wipes.
Presaturated wipes are available in a
variety of formats, substrates and sizes
suitable for every size and cleanliness of
cleanroom.
CONTEC PROCHLOR
Contec ProChlor is one of the fast acting,
sporicidal disinfectants available for life
science cleanroom use. Manufactured in
a Grade B cleanroom and filtered to
0.2µm Contec ProChlor is especially
suitable where a fast acting and effective
sporicide is needed. With a contact time
of only 1 min and low residue, Contec
ProChlor will be ideal to meet the MHRA’s
new requirement of a sporicidal phase
during transfer disinfection.
Contec ProChlor has a validated, 100%
reduction in spores (EN13697) in under 1
minute. Remarkably, for this level of
efficacy, Contec ProChlor carries no
associated hazard, as it is neither an
irritant or corrosive substance. Now
available sterile and double bagged,
Contec ProChlor is specifically designed
for all cleanroom use.
CONTEC HYDROPURE
For product contact areas, where surface
residues are not appropriate, Contec
HydroPure is a blend of stabilised 6%
hydrogen peroxide in WFI (EP) which
breaks down to water and oxygen leaving
no residue.
Contec HydroPure has a guaranteed
endotoxin level of less than 0.25EU/ml
and uniquely; is terminally sterilised at no
less than 25kGy. Sporicidal in 15 mins,
Contec HydroPure is manufactured using
the highest grade of hydrogen peroxide
and complements the hydrogen peroxide
used in vaporised systems.
CONTACT
For more information about Contec
products for cleanrooms and critical
environments, please contact us:
Contec
● Europe +33 (0)2 97 43 76 90
● Email [email protected]
● www.contecinc.com
HOW LONG DOES
IT TAKE TO...
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CONTEC PROCHLOR
COMPLETE SPORICIDAL ELIMINATION
IN LESS THAN 1 MINUTE*
Contec ProChlor is a new innovative sporicidal biocide with a proven
log 6 kill in under 60 secs (*EN 13697). Filtered and double bagged,
Contec ProChlor is specifically designed for use in pharmaceutical
cleanrooms. Available in a 1L trigger spray and 5L capped container.
Probably the fastest acting, cleanroom sporicide available.
Contact Contec at
[email protected] or by
calling 0845 652 2582
to request a sample.
www.contecinc.com
Use biocides safely. Always read the label and product information before use.
4 MINs
20
January 2015
industry news
PROCESS AUDIT IMPROVES CLEANING OF ESD CLOTHING
The Hohenstein Institute in
shades and the greying,
Germany has developed a
conclusions can be drawn
process audit to help
about the resistance of the
commercial laundries improve
PPE’s functionality. As well as
the way they clean high
using the test fabric, all aspects
visability and electrostatic
of the washing and drying
discharge (ESD) clothing,
processes such as thermal and
especially in the contract
mechanical characteristics and
laundering sector. The audit is
the use of chemicals and
for customer-specific treatment
detergents are analysed.
processes but applies
For professional ESD
Hohenstein experts are planning more test
regardless of the manufacturer
clothing,
a commercially
fabrics for PPE e.g. heat/flame resistance
of the textiles being processed.
available test overall goes
For personal protective equipment (PPE) high
through the customer’s cleaning process, again 25
visability clothing, the audit uses a new test fabric
times. The overall then undergoes standardised
consisting of standard commercially available
tests in accordance with DIN Norm 61340-5-1 and
woven and knitted fabric in all three fluorescent
its protective functionality is examined.
colours (yellow, orange-red and red) and including
The commercial laundries receive a certificate
the retro-reflective tape. This test fabric is soiled
confirming that their cleaning process is set up in
with up to six stains containing dense oil and soot
such a way that the protective function and service
particles and is put through the customer's cleaning
life of the ESD clothing is preserved and extended.
process 25 times. Standardised tests in accordance
This certificate is valid for a year and provides
with DIN EN ISO 20471 are then carried out at the
evidence that the commercial laundry offers
Hohenstein Institute.
maximum effectiveness in its cleaning processes.
By analysing the light density factor, the colour
www.hohenstein.de
EVENTS
18 FEBRUARY
Sterilisation,
Sanitisation and
Disinfection
A seminar and workshop
on effective contamination
control and the
appropriate steps to
manage deviations
www.phss.co.uk
26 FEBRUARY
Contamination
Control and
Microbiological Risk
Assessment
Nottingham, UK
This conference covers a
wide range of topics to
reduce contamination and
assess microbiological risk
in pharma and cosmetics.
www.pharmig.org.uk
3 – 4 MARCH
Medtec UK
ExCeL, London, UK
The event will cover a full
range of technologies and
solutions for the medical
life sciences sector.
www.medtecukshow.com
Ardmac to build cleanrooms for
the NBMC in Darlington, UK
Cleanroom design and construction specialist
Ardmac, based in Manchester, UK, has been
contracted to deliver new cleanroom facilities at
the National Biologics Manufacturing Centre
(NBMC) in Darlington.
Currently in the design phase, the project forms
part of the Centre for Process Innovation (CPI), a
Government-led initiative which aims to stimulate
growth in manufacturing sectors across the UK.
Working alongside Archial Norr and Interserve,
the project consists of full architectural design,
product selection and construction delivery. The
nature of the NBMC facility, which will provide
contract manufacturing services to clients in the
biosciences industry, means that the cleanroom
must be flexible to allow the continuous changing
of equipment and services for respective clients.
The NBMC space also includes an exhibition hall
with views into the new cleanrooms.
As part of this project, Ardmac will be providing
opaque LCD smart glass on the windows to allow
for observation and privacy when necessary.
Ardmac Business Development Manager,
Philippa King-Smith, said: ‘We are really looking
forward to seeing the project go live on site. Our
design team has worked well with the architectural
leads to ensure the GMP areas provide many
interesting features, all the while maintaining
compliance. The Ardmac, Archial Norr and
Interserve teams have worked extremely well
together and we look forward to seeing this project
through to completion.’ www.ardmac.com
VWR LAUNCHES ‘GOWN UP, GIVE BACK’
GARMENT RECYCLING SCHEME
VWR, a US provider of laboratory products,
services and solutions, has launched its second
garment recycling service. Called ‘Gown Up, Give
Back’, the service will allow VWR’s US customers
to recycle a variety of single-use garments.
Each year, millions of pounds of single-use
garments end up in landfill and VWR says its
recycling solution gives customers the opportunity
to give new life to their used garments. The plastic
waste from these garments is recycled into resin
that is used to make items such as composite
decking, railway sleepers and drainage pipes.
Similar to the company’s pipette tip box recycling
scheme, the ‘Gown Up, Give Back’ programme
provides a waste collection, shipment, and recycling
solution for most single-use garments, as long as
they are contamination-free and bought from VWR.
VWR’s ‘From the Lab Bench to the Park Bench’
pipette recycling scheme, launched in 2012, has
helped to divert more than 230,000 pipette tip
boxes, equal to 40,000lb (18,143kg) of waste, out of
landfills. The plastic waste collected in the US and
Canada for this programme is turned into pellets
and converted into park benches and other ecofriendly products.
‘VWR is excited to help support our customers’
sustainability goals by reducing their landfill waste
with our pipette tip box and garment recycling
solutions,’ said Mark McLoughlin, SVP and
President, US Lab and Distribution Services.
www.vwr.com
4 MARCH
Ethylene Oxide
Conference
Warwickshire, UK
This event will provide an
overview of ISO 11135:
2014 and the changes that
arise for ethylene oxide
sterilisation.
www.synergyhealthplc.
com
24 – 26 MARCH
Facilities
Management 2015
NEC, Birmingham, UK
This event for the facilities
industry will be co-located
with the Cleaning Expo.
www.easyfairs.com
31 MARCH – 2 APRIL
ContaminExpert/
ContaminExpo 2015
Paris, France
The latest developments in
controlling biological,
chemical and particle
contamination.
www.aspec.fr
21 – 23 APRIL
Interphex
New York, US
The single source for
biopharmaceutical
manufacturing solutions.
www.reedexpo.com
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Profile - Consumables
ATTENTION TO DETAIL IN
CRITICAL CLEANING
Investment in processing and support
equipment within cleanroom manufacturing
continues to rise year on year. Once the
investment is made, cleaning and
maintaining the machinery to the required
standard is essential.
Known for its range of products designed
for conventional wet and dry cleaning,
Micronova has made their core mopping
system more relevant by adding useful
accessories that simplify specialized
equipment cleaning – saving the operator
time and effort.
Inspection Mirror
Stainless Carts
INSPECTION MIRROR
The QDIST-66P Inspection Mirror has a highly
polished stainless steel surface that, when
attached to one of the various stainless steel
or fiberglass handles, allows the operator to
check under equipment, inside tanks and
around mixer blades to ensure that all
surfaces have been cleaned and
decontaminated. A 360o Swivel allows
optimum flexibility. Available with an
optional LED flashlight for use inside tanks
and other low-light applications.
Swab Holder
SWAB HOLDER
Ergonomic awareness along with safety
concerns mean that taking required samples
from surfaces in certain controlled
environment can be a challenge. The
QDSWT-01 SwabHolder attaches to any
length of the SSU- series of handles to
access awkward angles and hard to reach
areas. Used with the QDAH accordion handle
it allows the operator to reach above and
behind heavy fixtures and equipment.
The W-10 MegaWringer
Econo CurtainCleaner
ECONO CURTAINCLEANER
This simple, ‘squeegee’ like cleaning tool
cleans and/or dries both sides of vinyl strip
curtains at the same time cutting back on
time and operator effort. The no-nonsense
head fits onto even the longest Stainless or
Fiberglass handle to allow for extended reach
without the use of stepladder. A selection of
fabric slip covers are available.
STAINLESS CARTS & MEGAWRINGER
WET DRY WIPES FOR SCREEN AND
INSTRUMENT CLEANING
STAINLESS WIRE BRUSHES
Designed to clean sensitive instrument
panels in airline protocols, the fast drying
Wet/Dry Wipe has applications in controlled
environments for cleaning sensitive screens
and instrumentation.
100% Electropolished stainless steel. The C-9
series cart is available as a single, double or
triple unit and with the W-10 MegaWringer
efficiently wrings string and flat style mop
heads. All 304 grade stainless, both cart and
wringer elements break down for easy
autoclave and storage.
A selection of brushes offering different
widths, lengths and bristle stiffness cater to
pipe and vessel cleaning in labs and
production facilities. Available with a choice
of microfiber, polyester and irradiated slip
covers.
Stainless Wire Brushes
CONTACT
3431 W. Lomita Boulevard
Torrance, CA 90505-5010
● Tel (310) 784-6990
● Email [email protected]
● www.micronova-mfg.com
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4356
January 2015
25
BUSINESS
MOVING
ON UP
Many of the business areas
covered in Cleanroom
Technology saw M&A activity
in 2014 and out of nearly 20
deals, the US took the lion’s
share but there were some
important transactions in
Europe. Jane Ellis reports
By far the biggest deal in 2014 was
from Steris, which bought UK-based
Synergy Health for US$1.9bn in a cash
and stock deal.
Steris said it would create a new UK
company to undertake the acquisition,
joining a growing list of US companies
that are trying to cut their tax bills by
shifting their domicile from the US.
The combined company is expected to
have annual revenue of approximately
$2.6bn and 14,000 employees in more
than 60 countries, and the deal will result
in annual pre-tax cost savings of $30m.
For medical device manufacturers,
Steris’s Isomedix and Synergy’s Applied
Sterilisation Technologies (AST) will
create a leading global supplier with a
network of 58 facilities in 18 countries.
For hospitals, the combination of
Steris’s Infection Prevention and Services
businesses with Synergy’s Hospital
Sterilisation Services will strengthen the
breadth and depth of the offering,
accelerating the development of hospital
sterilisation outsourcing worldwide.
The transaction is expected to close by
31 March this year.
Another sizeable deal was US-based
Cantel Medical’s purchase of PuriCore
International, a UK provider of automated
endoscope reprocessors, endoscope drying
and storage cabinets, chemistry and
consumables and maintenance and
validation services, for $26.9m in cash.
PuriCore employs 120 people, including
a sales and service team, and has facilities
in Stafford and Clevedon, North Somerset.
Cantel, based in Little Falls, NJ, US
provides infection prevention products
and services. Products include medical
device reprocessing systems, advanced
water purification equipment,
disinfectants and sterility monitoring
devices.
Although the majority of transactions in the contamination control industry in 2014 took place in the
US, there were some big deals in Europe
Cantel said the deal would allow it to
expand its reach and capabilities in
international markets and provide a
platform for future expansion both in the
UK and continental Europe. It expects the
business to show ‘significant sales and
profit growth over the next several years’.
Meanwhile, Sterigenics, a global
provider of contract sterilisation, gamma
technologies and medical isotopes based in
Deerfield, Illinois, had a busy year, buying
three companies for $826m. These were
Gammarad, Italy’s leading gamma
sterilisation provider, as well as two firms
on its side of the Atlantic – Food
Technology Service, a Mulberry, FL
irradiation facility, and Nordion, a
Canadian supplier of sterilisation
technologies and medical isotopes.
Sterigenics’ CEO Michael Mulhern said
that in addition to these deals, the
company has committed more than $32m
in growth capital to expand existing
facilities across the Americas and Europe.
Growth in single-use systems
Single-use disposable solutions are seeing
increased use in aseptic environments and
two transactions in the US reflected their
growing popularity.
US laboratory products provider VWR
expanded its portfolio of products for the
life science and biopharmaceutical
industries with the acquisition of two
bioprocessing single-use system
integrators, Integra Companies and STI
Components.
Integra Companies provides single-use
connectivity solutions including tubing,
hoses and gaskets for high-purity
environments to customers in the
biopharmaceutical, food processing and
microelectronic industries in the
Northeast US. Established in 1974 and
headquartered in Devens, MA, the
company is ISO9001 certified and operates
two ISO Class 7 cleanrooms.
STI Components offers high-purity fluid
handling components and custom
engineered solutions to the same
industries, but to the Southeast US
region. Founded in 1987, the company’s
Morrisville, NC location is ISO9001:2008
certified and also operates a certified ISO
Class 7 cleanroom.
Meanwhile, European company
Sartorius Stedim Biotech (SSB), which
offers integrated solutions covering
fermentation, cell cultivation, filtration,
purification, fluid management and lab
technologies to the pharmaceutical and
biopharmaceutical industries, agreed to
take a majority stake in US start-up
company AllPure Technologies, based in
New Oxford, PA.
AllPure, which employs 25 people, has
been operating for four years and in 2013
reported revenue of around $3m. It
specialises in single-use components for
biopharmaceutical applications, such as
aseptic sampling techniques.
Reinhard Vogt, a member of SSB’s
Executive Board, said: ‘AllPure further
completes our portfolio with innovative
products that help our customers develop
and manufacture their pharmaceutical
drugs more safely safer and efficiently.’
The rise of modular cleanrooms, which
are enabling quick and flexible production
for pharmaceutical companies, was also a
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28
January 2015
BUSINESS
growing theme in 2014, and US
drugmaker Pfizer, through its venture
capital arm Pfizer Venture Investments
(PVI), made a ‘multi-million dollar’
investment in G-Con Manufacturing,
which develops autonomous cleanroom
PODs.
‘We are very encouraged and motivated
by this investment, which will accelerate
G-Con’s already rapid growth,’ said Maik
Jornitz, COO of G-Con Manufacturing.
Under the terms of the agreement,
PVI’s Bill Burkoth joined G-Con’s board
of directors. He said G-Con’s POD
technology ‘has the potential to change
the pharmaceutical manufacturing
landscape’.
‘The autonomous cleanroom PODs can
be deployed quickly and easily, which
allows manufacturers to distribute
medicines at the time they are needed and
also in smaller volumes. We are pleased to
help G-Con further capitalise on its
growth opportunities,’ he added.
PVI and G-Con will continue to work
together in the Portable Continuous
Miniature and Modular (PCMM)
consortium with GEA Process
Engineering to develop oral solid dosage
processing technology that addresses the
rapidly changing requirements of
pharmaceutical development and
manufacturing.
In the area of cleanroom design and
construction, there were two transactions
of note. In the UK, York-based MSS Clean
Technology was acquired by a new
company called IMCO (121014), formed by
Environmental Engineering, based in
Dukinfield, Cheshire, securing the jobs of
all 12 staff including the management.
MSS Clean Technology, established in
1982, specialises in the design,
manufacture, installation and
commissioning of laboratories, cleanrooms
and controlled environments. It operates
worldwide and has clients in the
pharmaceutical, biotech, healthcare and
electronics sectors. The company will
continue to trade under its original name.
Richard Asquith, Chairman of
Environmental Engineering, commented:
‘Environmental Engineering and MSS
have a good understanding of their
respective strengths and the acquisition
provides a natural extension of both the
capabilities and market position of the
combined business.’
In the second deal, AM Technical
Solutions (AMTS), an Austin, Texas-based
engineering, procurement, and
construction management company,
acquired Dallas-based L&L Maintenance
Company and L&L Cleanroom
Construction. L&L was founded in 1981
and has a large customer base in the
Southwest and Southeast of the US.
The acquisition builds on AMTS’s global
footprint and delivery of cleanroom
construction solutions in high-tech
environments. It also brings new in-house
capability to expand the company’s
integrated approach to clean
environments.
‘This acquisition will allow us to bring
complete architectural cleanroom builds to
our existing customer base as well as
continue to expand an ever-growing base
Watson-Marlow Pumps Group bought Bio Pure Technology, which specialises in the design and
production of advanced single-use tubing connector systems for biopharmaceutical customers
of semiconductor, life science and
university clients that L&L has had over
the last 30-plus years,’ said Tim Glasson,
AMTS SVP of Corporate Development.
AMTS says it has completed more than
5,000 projects, including construction
management, cleanroom certification,
design/build, QA/QC analytical testing,
and cleanroom testing.
Equipment suppliers get in on the act
M&A activity did not stop here, however,
with equipment suppliers getting in on
the act both in the US and Europe.
Particles Plus, a developer of particle
counters and vacuum pumps
headquartered in Stoughton, MA, US,
bought Airy Technology of Orem, Utah, a
manufacturer of handheld and remote
particle counter technology, to help it
move nearer to a leading position in the
indoor air quality and controlled
environments markets.
Airy Technology has 105 distributors in
27 countries and claims to have
established itself as one of the world’s
largest suppliers of handheld particle
counters. The company’s headquarters
will relocate to Stoughton, where it will
continue to operate as an independent
company. It also has operations in Japan
and China.
In the UK, another pump manufacturer,
Watson-Marlow Pumps Group (WMPG),
bought Bio Pure Technology through its
parent company Spirax-Sarco Engineering
for £8.5m.
Bio Pure, based in Portsmouth,
specialises in the design and production of
advanced single-use tubing connector
systems for biopharmaceutical customers.
The business was established in 1998 by
Roy Maunder, who will continue as a NonExecutive Director with Steven Feasey as
Sales Director.
WMPG said the Bio Pure brand is a
natural extension of its peristaltic pump
range, complementing its offering in the
biopharmaceutical sector, and joins a
portfolio comprising Watson-Marlow
Pumps, Watson-Marlow Tubing, Flexicon
Filling Systems, Alitea OEM Pumps,
MasoSine Process Pumps and Bredel Hose
Pumps. WMPG already had a strong
commercial relationship with Bio Pure,
having jointly promoted Watson-Marlow
pumps and tubing and Bio Pure
connectors to shared customers.
‘The strategic acquisition of Bio Pure
further broadens our product range and
strengthens Watson-Marlow’s position in
the single-use biopharmaceutical market,’
said Jay Whalen, President of the WatsonMarlow Pumps Group.
January 2015
29
BUSINESS
Meanwhile, the Mann+Hummel Group,
a German filtration specialist in the
automotive and mechanical engineering
industries, bought Vokes Air from private
equity firm The Riverside Company to
expand its presence in filtration markets
outside the automobile industry.
Based in Sweden, Vokes Air is a
filtration solutions provider that produces
and distributes filters for indoor and
process air purification. The company
employs 400 people in Europe, mainly in
Germany, Sweden, and the UK.
‘With Vokes Air, we enter a new market
with great potential,’ said Alfred Weber,
Chief Executive of Mann+Hummel. ‘This
acquisition creates new chances for both
the companies and the employees.’
Also in Europe, Swedish air filter and
clean air solution specialist Camfil
purchased Handte Umwelttechnik of
Germany. Handte, which has operations in
Switzerland, Czech Republic and China,
joined the Camfil Air Pollution Control
(APC) business unit, a specialist in
industrial dust and fume collection.
‘Handte has a full line of dust collectors,
mist collectors and wet scrubbers that
strategically complement the Farr Gold
Series cartridge dust collection line,’ said
Camfil APC’s President Lee Morgan.
‘The integration of these product lines
will broaden our portfolio and strengthen
the company’s industrial air pollution
control offerings to customers in the US
and internationally.’
Jakob Handte, former shareholder of
Handte, who will become Chief
Technology Officer of Camfil APC, added:
‘I am looking forward to further develop
the APC business of Camfil on a
worldwide basis in my new function.’
Key applications for Handte’s products
include metalworking and machining,
automotive, foundry, mining and dry
processing industries, including chemical,
food and pharmaceutical.
In the cleanroom consumables area,
DuPont Protection Technologies sold its
Sontara nonwovens business to
Switzerland-headquartered Jacob Holm.
Sontara produces nonwoven products
used in a variety of medical and wipes
applications. Jacob Holm is a leading
company for spun-laced nonwoven fabrics
used in the home care, hygiene and
industrial markets.
Polymer Group Inc (PGI), a US-based
supplier of nonwoven fabrics for infection
control, medical apparel and wound care
applications, as well as wipes, took a
controlling interest in Companhia
Providencia Industria e Comercio, a
Brazil-based manufacturer of nonwovens
used in similar applications.
There was also activity in the testing
and analysis area, another important part
of the controlled environment industry, as
witnessed by international food safety
company Neogen, based in Lansing,
Michigan, US, acquiring all the
outstanding stock of BioLumix. Also
located in Michigan, BioLumix makes
automated systems for the detection of
microbial contaminants.
Consolidates to offer rapid solutions
Neogen said it would consolidate the
BioLumix business with its Soleris
technology, which is used for the detection
of micro-organisms in the food industry, as
well as the nutraceutical market.
‘Combining the Soleris and BioLumix
technologies, market bases and
outstanding technical staff will greatly
enhance both businesses and offer
significant labour-saving rapid solutions
for the food, pharmaceutical and personal
care businesses,’ said James Herbert,
CEO and Chairman.
The BioLumix test platform includes an
instrument where test vials are incubated
and automatically read for results, and an
automatic system to alert users to sample
results. The basic unit accommodates 32
different test vials at a time and can be
combined in modules to handle up to
1,000 different samples simultaneously.
Test vials are the consumable portion of
the platform and contain growth
media and indicators for a number of
different micro-organisms. A sample is
simply added to the vial, and the vial
Top: Sartorius Stedim Biotech took a majority stake
in AllPure Technologies. Above: Handte joined the
Camfil Air Pollution Control (APC) business unit
inserted into the instrument.
BioLumix currently has 19 different
micro-organism tests. Specialised software
shows test results as soon as detections
occur, and avoids the need for involvement
from an operator. The software also
creates and maintains all the necessary
audit trails to comply with various
government regulations.
Meanwhile, Eurofins Scientific, a
product testing and analytical company,
purchased SF Analytical (SFA)
Laboratories for an undisclosed sum,
strengthening its growing presence in the
US, as well as expanding its current base
of operations in the Midwestern region.
Founded in 1900, SFA Labs is an
independent commercial testing
laboratory with multiple testing
disciplines, offering a range of chemistry,
nutrition, allergen and microbiological
testing for food processors and
manufacturers, in addition to
environmental and water testing.
Profile - Design & Build
EXPERIENCE BRINGS
REWARDS FOR CLEAN
ROOM CONSTRUCTION
cleanroom will facilitate production of wing
components for the Airbus A350 XWB jetliner
family when it becomes operational in 2015.
CRC is also working on specialist research
and laboratory facilities for the £90m
Technology and Innovation Centre building at
the University of Strathclyde. The project in a
specially designed building in the heart of
Glasgow will transform the way the university
and industry collaborate and innovate in their
research into power and energy, health and
manufacturing.
The National Graphene Institute
is due to open in 2015
Growing demand for high quality and cost
effective cleanroom solutions which also
push the boundaries of design and
sustainability has led to one of the busiest
years on record for the UK’s most
experienced cleanroom design and build
specialist, Clean Room Construction Ltd
(CRC).
This growth is being driven by the
development of new and emerging
technologies and biologics; healthier
pharmaceutical, hospital and healthcare
sectors and rising regulatory requirements to
safeguard the quality and integrity of
products and the safety of staff working on
them.
CRC’s managing director Steve Lawton
described 2014 as “full-on” with the Kentbased specialist working on numerous
flagship design and build projects. These
have included cleanroom facilities for the
prestigious £61m National Graphene Institute
at The University of Manchester and state-ofthe-art laboratories for the Cell Therapy
Catapult at Guy’s Hospital.
LIFT-OFF FOR SPACE-AGE PROJECTS
In 2014 CRC has continued to work with e2V
on facilities for high performance imaging
projects. e2V is the Chelmsford company
responsible for designing and supplying the
camera system that took ground-breaking
pictures of the comet’s surface from Philae
in the recent Rosetta comet mission.
CRC is also in the midst of delivering a
space-age facility at RAL Space, world
leaders in research and technology
development, space testing facilities,
instrument and mission design capability.
CRC is working with Willmott Dixon
Construction Ltd to engineer one of its tallest
cleanroom facilities on the site at the Harwell
Oxford Science and Innovation Campus in
Oxfordshire, with some ceilings exceeding
12m in height. Construction has started
linked to the £420m 3Ts redevelopment of
the Royal Sussex County Hospital. CRC is
working with Laing O’Rourke to provide
Brighton and Sussex University Hospitals
with temporary facilities for some of the
clinical services that need to move to make
room for the main redevelopment, enabling
the hospital to continue servicing the local
community during the redevelopment.
Meanwhile CRC is designing, building,
commissioning and validating a new millionpound cleanroom facility for GE Aviation at a
production site in Hamble-le-Rice. The
EXPERIENCE IS SECOND TO NONE
CRC’s Steve Lawton said: “Clean Room
Construction has been designing and building
cleanrooms across these pioneering science
and technology sectors for nearly 50 years.
We have a dedicated in-house team whose
expertise and experience is second to none,
with an average length of service for all staff
of more than 17 years. Our site managers
can even beat that, with an average 27 years
in post. That’s how we are able to
differentiate ourselves in a competitive
marketplace. Clients investing huge amounts
of money in world class facilities need to
know the company they are entrusting with
delivery of their complex projects is
experienced and reliable. We have always put
quality at the forefront of what we do and
have never compromised on that, even
during the recession. That’s why we’ve come
out of the tough times in a strong position.”
It promises to be a happy new year for CRC.
CONTACT
Clean Room Construction Ltd
●
Tel +44 (0) 1634 295111
●
Email [email protected]
●
www.crc-ltd.co.uk
EXPERIENCE COUNTS
WHEN YOU NEED
A CLEANROOM
Clean Room Construction (CRC) is the UK’s most
experienced cleanroom design and build specialist.
We also repair, refurbish and upgrade cleanroom
facilities while our in-house service team experts can
provide commissioning, qualification, validation and
maintenance services.
Contact us now to see how we can use our experience
to engineer a quality cleanroom solution for you.
Our clients span the science and technology
sectors in the UK and overseas including:
• Biotechnology
• Containment and laboratories
• Display technology
• General manufacturing
• Healthcare
• Hospitals
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January 2015
33
DESIGN & CONSTRUCTION
Pharmaceutical facilities are among
the most complex to build as the medicines
being produced are designed to be more
potent and require greater containment.
For example, Schilling Engineering of
Baden-Württemberg described the build of
200m2 of cleanrooms for German
parenteral nutrition and cytostatic
medicines producer Eurozyto.
Eurozyto wanted two separate labs –
cleanroom class GMP A in B. By
separating manufacturing into toxic and
non-toxic areas, it could avoid any crosscontamination. Schilling supplied its
CleanSteriCell cleanroom system, which
meets GMP requirements. In the first
facility, each lab is reached via a multilevel personnel and material lock system
that ensures structured work processes
and safety. Three personnel locks
arranged one after the other with
connected work preparation rooms
increase the cleanroom class to GMP B
using falling pressure differentials and
increased air change rates. Cytostatic
workbenches ensure germ-free conditions
and personnel safety during production.
The second lab, for parenteral nutrition,
was equipped with laminar flow
workbenches. Flush-mounted laminar
flow units with ultra low penetrating air
(ULPA) filters supply ultra-clean air via a
low-turbulence laminar flow system. The
circulation and air return is integrated
into the walls of the cleanrooms. An air
circulation process developed by Schilling
for use with pre-conditioned air is said to
allow the system to be operated with
greater energy efficiency than comparable
systems. A GMP-compliant monitoring
system ensures continuous control and
precise calibration of room parameters.
A special feature of the build was the
wall connectors, mounted using a siliconefree GMP sealing clip system. The
connections are not subject to any wear
and can be demounted for possible
expansions or reconfiguration.
Six pharmaceutical plants were
recognised in the ISPE’s 2014 Facility of
DESIGN TRENDS AND
BEST BUILDS OF 2014
In 2014 most new facilities were built around designs that would
offer future flexibility, energy savings and ease of maintenance.
Good use of space, daylight and HVAC were prerequisites and, for
some, enclosed process lines and single-use technologies were key
Transparency and flexibility were central
themes throughout Boehringer Ingelheim’s
recent Aseptic Area 5 and Combi Line project
the Year Awards programme. Among
them, Penn Pharmaceutical Services
designed a solid dose facility housing
small and large scale equipment to
manufacture 1kg–120kg batch sizes, using
full containment with an ability to process
multiple products simultaneously.
The facility was integrated into an
existing operational area in 12 months.
The small and large batch scale processes
were fully contained with integrated
transfer processes and ‘wash in place’
systems. Applications more common in
sterile and biologics facilities were
deployed into the granulation, tablet and
capsule production processes. The facility
was also designed to eliminate the need
for personal protective equipment (PPE)
in routine operations and to handle
Part of the new mammalian cell culture manufacturing facility at
Fujifilm Diosynth Biotechnologies in Billingham, UK
molecules with occupational exposure
limits down to 0.01μg/m³.
Clear vision
Transparency and flexibility were central
themes throughout Boehringer
Ingelheim’s Aseptic Area 5 and Combi
Line project. This project was winner of
the Equipment Innovation category.
Transparency was achieved by innovative
use of glass cleanroom walls, air returns,
and technical space, which allows visitors
on the outside to observe operations and
operators on the inside to make use of
exterior daylight and easily communicate
with each other.
Flexibility was another theme for this
project. The U-shape line design allowed
flexible use of individual processing units
while maximising operational time of the
area during decontamination of separate
isolators on the line.
Pfizer Ireland Pharmaceutical’s Grange
Castle manufacturing plant project
involved re-purposing existing production
space to add a new vaccine suite plus a
multiproduct small to medium scale drug
substance bioprocess suite. The company
had to demolish existing facilities and
construct new ones, without interfering
with existing operations. The project team
ensured the new production suites had the
latest, electronic, process analytical and
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36
January 2015
disposable technologies and a Lean
Management strategy was used
throughout, which won Pfizer Ireland the
Operational Excellence category.
F. Hoffmann-La Roche won the
Sustainability category for its project on
the Roche Analytical Laboratory B250 –
Q2K in Kaiseraugst, Switzerland. The
adopted building concepts ensured
maximum flexibility to meet future
requirements and a 130,000 ft2 facility
that exceeds Switzerland’s strict energy
efficiency requirements by 40%.
Features include labs with open ceilings
and optimum use of space to reduce the
facility footprint. A novel combination of
glass elements and blinds enabled
maximum use of natural daylight. Energysaving features included: heat recovery
from an existing data centre; solar roof
panels; and a green roof to conserve water
and create a friendly habitat. An
innovative design to reduce air changes by
over 50% was developed using a system
that has a two-step response to demand
changes, which involves cooling panels.
The facility also regulates airflow to a
minimum during off-hours.
Disposable technology
Single-use technology was a key topic in
2014. Rentschler, one of the world’s first
biopharmaceutical toll manufacturers to
establish a complete single-use plant for
the upstream and downstream area,
highlighted the design requirements of
such facilities.
The company had a flexible disposable
concept consisting of two multi-product
single-use bioreactor systems with two
1,000L bioreactors and an additional
2,000L bioreactor set to follow. This
allows easy scale-up, reduced production
costs and product cycle times.
The disposable plant involves four
independent all-purpose cleanroom suites
for operating the 100% mobile one-way
production plant for upstream and
downstream processing as well as an
inoculum suite. All the cleanroom suites
are connected to a plant-wide data logging
system which is preconfigured for ‘plug
and play’ mobile production equipment.
What makes single-use facilities
attractive is their cheap and fast
implementation. Rentschler says the
project lead time for implementation is
reduced by at least eight months
compared with traditional stainless steel
based facilities.
Closed process systems were also
introduced, which can reduce costs while
also maintaining segregation for
individual products. Closed systems still
Fraunhofer IPA and Romania’s Microelectronica
joined forces to build a new LED facility and a
specialist quality and cleanliness competence
centre in Romania
require fixed components, such as the
high-purity process piping, said
Rentschler, but can be combined with
single-use products to create an efficient
process operation.
The production of stem cells for
research and therapeutic use is a new and
growing area, and providing the right
environment for their production, use and
storage was a theme considered by MRC
Systems when it described the design and
build of the Bioscience Institute’s cell
factory in San Marino, Dubai. This facility
is dedicated to biological cryopreservation,
cellular culture and scientific research.
Extraction, analysis, expansion and
programmed freezing of different cell
types are carried out in its labs. For the
cleanroom, Bioscience required a modular
design, meeting international cleanroom
standards and European GMP.
The facility is split into two parts: the
first is where patients are received for
consultations and medical procedures; the
second part houses the cryo-preservation
area, labs and cleanrooms. The
cryopreservation area was fitted with
sensors operating an exhaust system
designed to maintain safe concentration
levels of oxygen in the air. This area has
direct access to the outside to allow for the
movement of nitrogen tanks in and out
without passing through the facility or the
common areas of the building.
Samples obtained from patients are
taken to the labs where tests are
conducted, and the materials are then
passed through to one of the cleanrooms
for further processing. A grade A laminar
flow cabinet was installed to provide a
sterile environment for sample testing. In
the classified area, separate personnel
entry and exit routes were provided. A
double-sided garment cupboard in the wall
separating these two areas allowed
operators to leave their lab coats in the
changing room going in and take them on
the way out without re-entering the
changing room. Both of these areas are
maintained at Class 7. Once through the
gowning area operators pass through a
connecting corridor maintained at Class 7
to another Class 7 area, where
refrigerators and freezers are installed for
cell preservation. Also through this
connecting corridor operators will be able
to access all three Class 5 cleanrooms.
Each cleanroom has its own changing
room and interlocked pass-through box for
material transfer. A grade A laminar flow
cabinet, an incubator (with space for more
in the future), refrigerator and
workstation with microscope were fitted
in each cleanroom.
All Class 7 and 5 areas have separate air
handling units and a continuous
monitoring system tracking temperature,
relative humidity, room pressure and
particle count. Two separate air handling
units provide air to the different classified
areas. These were installed in a compact
technical space towards the back of the
cleanrooms. As in the cryopreservation
area, a door provides access for
maintenance personnel without needing to
pass through the cleanroom. The
cleanroom ceiling is also designed to allow
maintenance access to services above.
The modular system chosen for this
build is manufactured from glass
reinforced polyester, which has benefits in
terms of chemical resistance, hygiene,
January 2015
37
easy maintenance and cleandown.
Ardmac was involved in the build of a
cell culture facility in the UK – the
mammalian cell culture manufacturing
facility at Fujifilm Diosynth
Biotechnologies in Billingham. Working
alongside main contractor M&W Group,
Ardmac undertook a modular construction
project that involved the installation of
Dagard products, including walls, liner
and walk-on ceilings for construction
access. This was completed with fully
flush lighting top and bottom. Ardmac
also provided bespoke stainless steel
utility panels to bring services into the
cleanroom areas, and fully flush glazing
panels around the perimeter corridor.
Medical devices
As medical devices become more
sophisticated, there is increased need to
reduce contamination in the production
and assembly of components. For
component manufacturers, such as
Advanex Europe, this means developing
methods to reduce particulate. Advanex
produces metal and plastic components
used in devices such as inhalers, auto
injection systems and nasal sprays.
The design of each component and its
potential for generating particulate is
carefully considered. Where springs are
ultimately to be assembled into devices
within cleanrooms, customers need
components to be free from biological
contamination, as well as particulate.
Advanex installed two ISO Class 7
cleanrooms – up to 10,000 particles/ft3 of
air – so that parts can be cleaned inhouse. The facility allows product to be
passed into the cleanroom via an airlock
‘pass-through’ directly from the clean
manufacturing area. Once inside the
cleanroom, the parts are ultrasonically
cleaned, double-bagged within the
cleanroom, and passed through a further
airlock to await despatch.
The GMP Group demonstrated that
facilities meeting the highest standards
can be achieved by repurposing existing
office buildings. It achieved such a
conversion for Medreich’s new blister
packaging facility. This comprised primary
and secondary packaging within ISO Class
8 cleanrooms and controlled non-classified
areas. The central courtyard of the
building was used (on three levels) to
create the plant space: air handling units
on the ground floor; compressed air and
pumping on the first floor; and
refrigeration on the top floor.
Electronics
A joint project between Fraunhofer IPA
and Romania’s Microelectronica resulted
in a new LED facility and a specialist
quality and cleanliness competence centre
in Romania. The Fraunhofer IPA
Department of Ultraclean Technology and
Micromanufacturing was responsible for
its design. The centre has a cleanroom
area of about 120m² with the highest
technologically achievable air cleanliness
level of Class 1. Here, services for verifying
dimensional accuracy and assessing
cleanliness are carried out as well as
inspections and precision cleaning with
CO2 snow. A further 100m² of clean zones
were built with controlled conditions that
can be used to inspect technical
cleanliness.
Creating the perfect
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With our many years of global experience, Envair have a proven ability
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or email
[email protected]
40
January 2015
Rayner Intraocular Lenses, the
world-leading life sciences company, is the
only manufacturer of intraocular lenses
(IOLs) in the UK. It designs and
manufactures IOLs and proprietary
injection devices for use in cataract
surgery and its products have been used to
surgically restore the sight of millions of
people worldwide.
The company is a member of the
Rayner group, which has had interests in
optics since it was established in 1910.
The company has grown continually, now
selling to more than 70 countries and it
remains at the forefront of innovation.
To support future growth, the company
is moving to a new state-of-the-art
manufacturing plant that will
dramatically increase its production
capacity.
The creation of this world-class facility,
which is due to open in October 2015, has
been a collaboration between Morgan
Sindall Professional Services (MSPS), the
multidisciplinary design consultancy, and
Rayner’s internal resource. MSPS is
providing architectural, civil and
structural, process, mechanical and
electrical, BREEAM and CDM services.
With experience that has seen it design in
excess of two million square feet of
cleanroom space over the past 20 years, it
is well placed to partner with Rayner to
ensure the new facility delivers real value.
The team includes Mike Collins, a
consultant project director at Rayner,
Mark Dickson, sector director of life
sciences at MSPS and David Downing,
MSPS’s principal architect.
Facility requirements: Having
predicted reaching maximum production
capacity in its existing facility, Rayner put
out to tender a brief that would futureproof its production capabilities.
Implantable medical devices are subject
to rigorous technical and quality
standards, imposed by the regulatory
authorities around the world.
With this in mind, Mike Collins
comments: ‘In partnership with MSPS,
Rayner will deliver a state-of-the-art
manufacturing facility producing
intraocular lenses for sale to markets
worldwide. The decision to base the
facility in the UK is a tribute to the
quality and productivity leap that will be
achieved in this country.’
MSPS’s front-end engineering and
process skills were employed to develop
User Requirement Specifications (URS)
and the multidisciplinary design solution
was developed in a Buildings Information
Management (BIM) environment, coordinated through the building design
An artist’s impression of Rayner’s planned
intraocular lens production facility
A FUTURE-PROOF
FACILITY FOR LENS
PRODUCTION
When designing a new production facility for a leading life
sciences company, Morgan Sindall Professional Services set out to
create the perfect environment to promote best practice
software Revit, such that MSPS could
clearly and visually communicate the
design’s attributes and benefits.
Part of the MSPS process engineering
consultation included production of the
Process Equipment Requirement
Specifications, which included many
complex bespoke items. This translation of
critical user requirements, of both
performance and validation, into detailed
documents for the supplying vendors was
successfully achieved with a collaborative
approach, led by MSPS, with input from
Rayner’s operations team. The equipment
chosen will deliver the greatest efficiency
and benefits to the business’s production.
The new development is close enough to
Rayner’s existing facility to retain its
highly skilled, specialised workforce and
the consultancy will support a phased
occupation to take place, ensuring no
interruption to production.
CO2 and energy consumption: A key
driver for Rayner was minimising the
overall energy consumption that is often
associated with ISO Class 7 and 8
cleanrooms. To achieve this, studies were
undertaken to determine the most
efficient and practical way of reducing
CO2 and energy use.
The studies concluded that optimising
the efficiency of the central plant and
distribution systems, rather than
significantly improving the fabric
performance of the building, was the most
efficient solution, due to the large amount
of air that has to be conditioned and
circulated through the cleanrooms. For
this reason the following features were
incorporated into the design:
● Reduction in specific fan powers by
limiting the velocity of air within HVAC
system components and by specifying ‘low
pressure loss’ fittings
● All pump and fan motors over 1.1kW
will incorporate variable speed drives
● All fan and pump motors will be
minimum IE2 Class High Efficiency
● Variable capacity HVAC systems
(capacity modulation depending on
demand and night set-back air-change
rates in cleanrooms)
January 2015
41
● The low temperature hot water (LTHW)
and chilled water system serving the
HVAC equipment is a two-port system
incorporating variable speed pumps to
deliver LTHW and chilled water volume as
required by the HVAC coils at any given
time
● Selection of high efficiency chiller plant
(i.e. plant will have a better Energy
Efficiency Ratio (EER) than the minimum
of 2.5 set out in the Non-domestic
building services compliance guide)
● Selection of high efficiency boiler plant
(i.e. plant will have a better gross seasonal
efficiency than the minimum of 86% set
out in the Non-domestic building services
compliance guide)
● A low air leakage (permeability) for the
building envelope has been specified –
5m3/(hr/m2) at 50Pa; this is half the
minimum requirements of a new build
● Implementation of combined heat and
power (CHP) to input into the building’s
heating, process and power systems. This
will only have an impact of reducing CO2.
Based on a CHP electrical output of
534,360kWh p.a., the CHP will provide
12% of the building’s total energy
consumption. This exceeds the planning
requirement of 10% energy provision
through renewable energy.
These also significantly contributed to
achieving the BREEAM ‘very good’ status,
a requirement of the UK Planning
authorities.
Future capacity: The facility has been
designed utilising lean manufacturing
principles, which make processes more
efficient with the systematic elimination
of waste, adding overall value to a
manufacturing facility for the duration of
its lifecycle.
One of the disadvantages of building a
lean facility, however, is that increasing
capacity through further waste reduction
is no longer an option, since nearly all
waste should have already been
eliminated. To resolve this, an innovative
solution was devised where, by increasing
the footprint of the initial processing area,
it will be possible to increase initial
capacity by more than 300% during the
lifecycle of the facility, at minimal initial
investment.
Further increases in both efficiency and
capacity are already being worked on
through process development. However, in
this tightly regulated industry these
changes can take considerable time and
resource to implement. This solution
allows Rayner the time to look at process
development as part of a future growth
strategy.
Maintaining a cleanroom
environment – contamination:
Unsurprisingly, when manufacturing
products that are surgically implanted
into the human body, contamination
The new building, due
to open in October
2015, has been
designed to achieve
the BREEAM ‘Very
Good’ status
control and therefore retaining a
cleanroom environment with not only
particulate filtration, but also tight
humidity control of the utmost integrity, is
crucial. Design forethought into
maintenance is therefore critical to ensure
electrical fittings, for example, can be
changed and machinery and equipment
maintained without losing the integrity of
the space.
Decisions were made early in the design
process to enable the cleanroom areas to
be easily maintained with minimum
impact on the process equipment, and
therefore the process flows.
Both process and build environment
equipment and systems were categorised
into one of the following:
● Direct impact – where failure directly
affects product quality and/or safety
(usually process equipment)
● Indirect impact – where failure may
indirectly affect product quality and/or
safety (HVAC and process utilities)
● No impact – where failure will not
affect final product quality/safety.
All direct impact equipment and
systems will be the subject of rigorous
audit by the US Food and Drug
Administration (FDA) and the UK
Medicines and Healthcare products
Regulatory Agency (MHRA). The audits
will consider all aspects of the equipment,
including maintenance. Standard
operating procedures (SOPs) will be
established for the operation and
maintenance of such equipment, and to
make the audit procedure as
straightforward as possible, it is essential
that processes are robustly carried out
and reported.
In addition to the above, intelligent
design has been used to reduce the risk of
maintenance affecting systems indirectly
in the following ways:
System redundancy
Critical systems have a level of in-built
redundancy to ensure a backup of
components and methodologies during
failure and/or maintenance operations.
Locating maintainable devices
outside the clean area
A full walk-on ceiling has been
incorporated over the cleanrooms so that
maintenance can be done from outside the
clean area. Back access luminaires will be
used so that they can be maintained from
the walk-on ceiling.
Using remote control centres to
monitor environment
Electronic monitoring will be installed to
enable the environment within the
cleanroom to be monitored and adjusted
from outside.
42
January 2015
Separating critical environmental
management system (EMS) from
building management system (BMS)
By separating the two management
systems, the EMS, which is audited by the
FDA and MHRA, can be regulated without
an overhaul of the entire system.
Good Manufacturing Practice: This
is key to the design of the new facility, and
will be integral to all aspects of the
building including its operation, the
materials used and their cleaning and
maintenance. Auditors will regard
maintenance as a GMP risk, and so robust
documentation will be used to mitigate
that risk and assure auditors that the
necessary steps are taken.
The required auditing of such facilities
reaches far beyond the documentation for
specific equipment review; for example,
GMP regulations require ongoing proof
that all employees are trained
appropriately before they enter GMP
areas to carry out maintenance. Training
includes a thorough understanding of the
need for policies, procedures and work
instructions for all direct and indirect
impact equipment and systems.
A low air leakage
(permeability) for the
building envelope has
been specified –
5m3/(hr/m2) at 50Pa
Mark Dickson says MSPS was chosen
for its leading experience in complex
manufacturing: ‘We have delivered a
design that makes intelligent use of
internal space to ensure increased output
and a reduction in operating costs. Our
design goes beyond building regulations to
reduce energy consumption, which is
detailed on a per lens basis.’
The design has been used to create an
environment that promotes best practice.
The end result will be a facility that
supports the business in delivering
intraocular lenses for sale in growing
markets worldwide.
CONTACT
Morgan Sindall Professional Services
20 Timothy’s Bridge Road
Stratford-Upon-Avon
Warwickshire CV37 9NJ
UK
T+44 1789 208 252
www.professionalservices.
morgansindall.com
FPS, the natural choice
for the containment systems in the
pharmaceutical industry
synthesis
INDEPENDENT VALIDATION SPECIALISTS
drying
milling/micronization
● Cleanroom – commissioning & validation
● Microbiological Safety Cabinet – installation & relocation,
commissioning, validation, fumigation, filter replacement &
repairs
packaging
● Fume Cupboard & LEV – type testing, commissioning
including containment testing, service and COSHH inspections,
fault finding, carbon filter replacement & testing, repairs
granulation
● Containment facilities CL 3 & 4 (ACDP, SAPO, DEFRA) –
advice on design, provision of fumigation protocol, fumigation,
commissioning, validation, room integrity testing, fault finding &
filter replacement
Isolators for processing high potent and/or sterile drugs
Complete micronization systems
www.crowthornehitec.co.uk
Tel+44 (0) 1252 372333
Our working style
We do not have a solution for everything, but all the solutions you will need
WE do not only DESIGN equipment, but SYNERGIES between our technology
and your operations. We know what you really need, without the need you let us know
Because our service for the chemical pharmaceutical industry is the fruit of our efforts.
F.P.S. Food and Pharma Systems - Via Vandelli, 20 - 22100 - Como - Italia
Tel. +39 031 543429 - www.foodpharmasystems.com
● Fumigation Service – we offer a routine and emergency
fumigation service using either formaldehyde or VHP
Micronization & Containment Solutions
Crowthorne Hi-Tec Services Ltd /
Unit 16 Farnborough Business Centre / Eelmoor Road /
Farnborough / Hants / GU14 7XA
WE’RE HIRING
Business Development Manager - UK Market
Permanent | Location - Home Based/England | Salary - £Negotiable
ClearSphere is a single-source specialist in controlled environment technology, with 20 years’ experience delivering the highest
standards to the Irish, UK and European Markets. The company takes pride in its reputation for excellence as a one-stop-shop for
clean operations for the Life Science / Medical industry. Due to expansion we are now looking to appoint an experienced Business
Development Manager to cover the UK market.
This is an exciting opportunity to join a growing business and take control of Sales & BD for the whole of the UK.
The role will involve creating a portfolio of clients, maintaining existing client relationships, identifying opportunities,
account management and closing sales.
Key Responsibilities:
•
•
•
•
•
•
Full Sales cycle Management of UK Sales.
Growing existing client base as well as developing
new business opportunities.
Develop knowledge of the Company's products
and solutions.
Sourcing key decision makers in UK Life Science companies.
Conduct market research on sector activity and
competitor knowledge.
Representing the business in a polished, professional
manner at all business meetings and events.
•
•
SOLUTIONS FOR CONTROLLED ENVIRONMENTS
THINK CLEAN AIR.
Cleanrroom,
Cleanroom,
o
Suite
Containment
Laboratory
Aseptic Suit
e and Cont
ainment Labor
atory
specialistt within the pharmaceutical,
design and build specialis
pharmaceutical,
manufacturing
sectors.
NHS, precision
prrecision
ecisio
e
manuf
acturing and rresearch
e rch
esear
c sect
orrss.
MHRA, FDA,
Compliance.
FDA, EA and ACDP
ACDP Complianc
e.
F
For
or mor
more
re inf
information
ormation or tto
o rrequest
eques
e
site
t a sit
e visit ccontact
ontact us on:
[email protected]
+44 (0)1489 885111 or email: sal
[email protected]
www
www.bassaire.co.uk
.bassaire.co.uk
Collaborate with internal departments on campaigns
to drive new leads.
Report on sales activity, appointments, inquiries,
calls and proposals.
The ideal candidate will have a strong proven
background in B2B business development experience
of selling Cleanroom and/or Containment solutions to
the UK Market.
If you are interested in applying for this role please
send your CV in Word format to [email protected]
THINK BASSAIRE.
• All types & gr
grades
ades of cl
cleanroom
eanrroom
o
acilities
• Aseptic preparation
prrepar
e ation ffacilities
• P
ortable/Transportable unit hir
re
Portable/Transportable
hire
• Refurbishment, e
xpansion and modific
expansion
modification
existing
ation of e
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• In-house servic
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service,
maintenance
engineers
alidation engineer
rs
44
January 2015
HVAC
HVAC IMPROVEMENTS
CUT ENERGY COSTS
With energy still a major cost for laboratories and cleanrooms,
cutting usage was the major trend in 2014. Susan Birks
highlights the best reported projects for improving HVAC
HVAC systems in life science laboratories
are high users of energy and, if not well
designed and finely tuned, can make labs
expensive to run. In the past, the trend
has been to overspecify with a view to
maximising safety, but as energy costs
have risen and budgets tightened
companies have been looking to optimise
plant location and load sizing. This
enables organisations to specify smaller
air handling units (AHUs) and cut down
on expensive ductwork. Innovative
technology for new builds or that can be
retrofitted is also being employed to cut
HVAC costs.
Among the case studies presented at the
Supporting World Class Science
Conference, held at King’s College,
London in September in conjuction with
the S-Lab Awards, was the Hutchison
Medical Research Centre in Cambridge,
UK, which was built over a decade ago as
a joint venture between the UK Medical
Research Council (MRC) and Cambridge
University for translational cancer
research. The biomedical ‘wet lab’ for 150
scientists and support staff consists of five
floors, three of which house research labs,
one support floor and a top floor plant
room. The labs were arranged into four
areas with offices in the corners divided
by a cross-shaped area in the centre that
houses both equipment- and cold-rooms.
However, the building had several HVAC
design flaws.
In 2013, it transferred wholly to
Cambridge University and an energysaving initiative was put in place in which
the HVAC was reviewed. The building
suffered from leaking valves that
controlled the chilled water heat
exchangers in the air handling units and
the malfunctioning air handling units
were also creating pressure differential
which led to a higher energy demand.
Removing them eliminated the pressure
differential, resulting in a drop in the fan
curve and a fall in energy demand.
Retrofitted standalone fan coil units in
the offices to maintain comfortable
temperatures and keep equipment rooms
cool led to wide temperature fluctuations
during working hours. This was improved
such that the rooms would reach set point
by the time employees arrived in the
morning and would remain at a
comfortable temperature throughout.
A lab ventilation management system
from Aircuity was also installed. Rather
than the ventilation system running 24/7
at 20 air changes an hour (ACH), the
Aircuity system organised the ventilation
in accordance with the rate of occupancy
of the labs. The health and safety team at
MRC was involved throughout the
implementation, to allay concerns that
reducing the air change rate (ACR) in labs
could compromise worker safety in case of
a spillage. As a result of the changes, the
company saw a fall of 37% in gas
consumption in kWh in the period May to
October 2013 compared with the same
months the previous year.
In a US case study, the Oklahoma
Medical Research Foundation (OKMRF)
revealed how when designing its new
Research Tower the organisation managed
to reduce the load by the use of Chilled
Beams and Venturi Wedges. Installing
these technologies enabled the use of
smaller AHUs, smaller and fewer ducts,
reduced chilled water and steam
requirements, leading to reduced overall
energy and no need for flow tracking
controls. The gains made, however, had to
be balanced with the need for a secondary
water loop and the requirement for
constant volume air.
Many laboratories were managing to
safely ratchet back ACRs during periods of
inactivity. At Newcastle University
Institute of Neurosciences, for example,
the department’s new extension had an
AHU that enabled it able to switch
between 15 ACH when research was going
on and 4 ACH when rooms were out of
use. But it was pointed out that reduced
air flow meant that the overall cooling
capacity also reduces – so it should be
kept in mind that extra cooling
contingency may be required to
compensate for this.
Vivariums are one of the biggest users
of ventilation and have specific ACRs
(usually 15 ACH) to ensure that animals
are comfortable and that workers do not
suffer from exposure to allergens or high
levels of ammonia.
Tecniplast, which designs ventilation
systems for vivariums, successfully
reduced energy costs by separating the
room ventilation from that of the cages.
Its Airflow Solution integrates
Individually Ventilated Caging (IVC) air
delivery and exhaust with the building’s
air handling system. It employs a MultiFlow AHU design and includes a climate
control system connected to each cage
rack that continuously monitors and
maintains the relative humidity. This
means individual cages don’t change their
pressure mode with a change in the
environment. Also by taking the air in the
room (not in the cages) from outside there
is no need to worry about humidity; only
the air going to the cages has to be treated
for humidity, creating a big saving.
Wind responsive fume extraction
For many organisations, fume cupboard
use is the greatest energy consumer, as a
rapid movement of air is required to keep
the user safe. The air in the fume
cupboard is then often discharged via
fume stacks on the roof of buildings.
Mark Turner, Head of Engineering
Services at Southampton University
presented a project carried out with the
help of KJ Tait Associates that used wind
responsive fume extract linked to realtime monitoring of variable air volume
(VAV) fume cupboard sash positions.
Fume cupboards are designed to operate
at a face velocity sufficient to contain any
January 2015
45
HVAC
Tecniplast's Airflow Solution integrates Individually
Ventilated Caging (IVC) air delivery and exhaust
with the building’s air handling system
fumes created within them. This rate is
normally set at 0.5m/s, although in some
instances it can be set lower than this,
depending upon the particular
circumstances; this means that closed
sashes result in a far lower extract rate
being required than that when the sash is
fully open.
Although the guidance contained in BS
EN14175-Part 2 results in safe dispersal
of fumes in almost all circumstances by
‘working on the safe side’, it is likely to
result in excessively high discharge rates
(and hence energy consumption) for most
of the time. This is because it is only
during very windy weather from certain
directions that fumes are likely to be
driven by eddy currents down to occupied
areas if velocities are too low. For most of
the time the fumes will disperse upwards
causing no excessive concentrations.
This project addressed this issue by
constructing a physical model of the lab
building and surrounding buildings. The
model was then tested in a wind tunnel
(by Brad Cochran of Cermak in the US)
to determine a ‘lookup table’ of exhaust
velocity required for differing wind speeds
and directions.
A weather station was fitted to the
neighbouring building to give velocity and
direction readings and the lookup table
was then built into the Building Energy
Management System that controls the fan
speed, reducing it to the minimum value
that will ensure good fume dispersal
whatever the weather. Now when a signal
comes from a VAV controller it will stage
in exhaust fans by modulating the damper
to bring in air.
Reducing a fan by a small amount can
produce huge power savings. The project
saved electricity with a value of £47k in
its first full year of operation, a rate that
would recoup the capital investment of
£114k in just two-and-a half years.
Matt Harris, Head of Energy and
Compliance Division at energy efficiency
consultancy EECO2, presented a case
study where energy savings could be made
on fume cupboard use. His advice was to
be clear about the baseline and set useful
alerts on key metrics. In a case study
involving The Wilton Centre (originally a
facility owned by ICI but subsequently
sold and redeveloped into a multitenanted technical and business centre)
some 50 extract fans were removed and a
ducted bridge was installed. The supply
AHUs were upgraded; low energy
filtration and high efficiency motors were
introduced; VAV dampers were installed,
along with fume cupboard VAV controls
and room-by-room pressure differential
control of supply air.
The retrofitting of VAV fume cupboards
and automatic sash closing was a common
theme. Graham Eady, of airflow monitors
and controls provider TEL, presented a
case study on Manchester Metropolitan
University’s John Dalton Tower, which
had 48 Constant Air Volume (CAV) fume
hoods working 24/7. The inefficient
system was costing in the region of
$120,000 per month in electricity
operating costs. TEL devised a retrofit
solution for conversion to a VAV scheme.
Automatic sash closing requires a
sensor that detects the presence of the
operator. The sensor will re-learn the area
if objects are placed in front of the fume
hood, e.g. stools, equipment, etc. Only
when the operator moves away from the
fume hood does the sensor tell the sash
drive to close. According to TEL, fitting
its VAV control to fume hoods and linking
this to the lab air supply would give up to
80% energy savings when the sash is
closed, and the Auto Sash Closer saves
energy by closing the fume hood when the
operator walks away.
Fume cupboard standards
Changes to standards for fume cupboard
and ventilation design was the topic
presented by Mike Dockery, MD of Sui
Generis. As a lab design consultant, he is
also Chairman of the BSI Lab Technical
Committee LBI/1-1 (furniture and
fittings), Chairman UK delegation lead to
the CEN TC332 WG4 Fume Cupboards
Technical Committee.
He discussed several changes to the
standards that are imminent. For
example, the release of the first part of a
Filtration Fume Cupboards (FFCs)
standard covering recirculation filtration
devices (RFFCs) can be expected in 2015
with ducted units (DFFCs) to follow.
It was also proposed that the 2015
release of a lab ventilation Code of
Practice would also cover microbiological
safety cabinets. He also indicated that a
forum was to be hosted at ACHEMA 2015,
at which the aim was to ‘set a direction
for an ISO standard for fume cupboards’.
Questioning old norms and moving from
guesstimates to real testing has also been
crucial to the implementation of new
technology that can cut HVAC costs. In
August 2014, Alexander Fedotov, Invarproject, looked at ways of reducing energy
consumption-based examples and real
project figures.
He highlighted the fact that most
normative documents do not specify exact
numbers for ACRs, yet the inclusion of a
set figure in some early US documents
derived from the 1950s has carried
through to some important standards
used today. This means some companies
and regulators still work to a set figure
(the most common being 20 ACH).
He also discussed how cleanroom
clothes have an impact on ACR and how it
is possible to reduce the ACR from 20 to
10 ACH by improving the quality of
garments, without other expense.
Among his considerations for making
savings were:
● reducing cleanroom size to a minimum
● avoiding over-specification of cleanliness
class
● use of HEPA filters with reduced
pressure drop (membrane filter 50 Pa
instead of 250 Pa glass fibre filters)
● sealing all leaks
● local protection where higher cleanliness
class is maintained in a limited area as
required by a process
● minimising the number of personnel
and using technologies that don’t require
people (closed systems, RABS, isolators)
● careful attention to operation, garments,
hygiene, training, etc.
● reducing air flow rate when not in
operation
● avoiding over-specification of ACRs and
recovery time
● determining that actual required air
flow rates during testing and operation
and adjusting ACR to a minimum based
on these data.
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January 2015
47
CLOTHING & PPE
According to research and consulting
firm MarketsandMarkets, the overall
global market for antimicrobial coatings
was US$41.5bn in 2012 and will have a
compound annual growth rate (CAGR) of
11.8% from 2013 to 2018; protective
gowns are a growing part of this market.
Anticipating this growth, the
International Organisation for
Standardisation (ISO), is developing
ISO/NP 18266, which would create
performance requirements and test
methods for protective clothing against
infective agents. The standard is now in
ISO’s preparatory stage.
‘The ISO/NP 18266 describes systems
and their performance, which represent a
barrier against bacteria and viruses,’ said
Rainer Steffens, the project leader for this
standard.
While this standard would apply
globally, a similar set of rules has existed
in Europe since 2003 – which is the reason
why Steffens, who has also worked with
the German Institute for Standardisation
(Deutsches Institut für Normung or DIN),
proposed the standard to the ISO.
The European Committee for
Standardisation’s (CEN) standard 14126
specifies requirements and test methods
for re-usable and limited use protective
clothing, providing protection against
infective agents.
In April, ISO released standard ISO
17299 for odour control textile products
that differentiates them from
antimicrobial control standards; this was
seen as a positive move by antimicrobial
producers.
In North America and Europe, the
antimicrobial textiles sector has been
subject to a significant number of updates
in standards and testing procedures. The
American Society for Testing and
Materials (ASTM), for example, has
several voluntary standards.
The method that has most affected
textile testing is ASTM 2149 – a dynamic
shake flask method designed to assess the
ability of fabrics to inhibit E.coli bacteria
that it is helping companies test for, and
improve, antimicrobial durability, even
when fabrics have been washed and worn.
‘There are many treatments now that
are either bound or optimised within or on
the polymer that lend themselves to much
longer durability,’ said Daniel Price, a
member of ASTM subcommittee E35.15
on antimicrobial agents. ‘And there are
some particular silver species within some
of these treatments that seem actually to
get better the more it’s washed.’
One of the most important areas of
focus is developing new ways of
ANTIMICROBIALS HELP
PREVENT THE SPREAD
OF INFECTION
New standards in testing antimicrobial textiles and garments
designed to cut hospital acquired infections, and greener solutions
to garment disposal are among some of the main developments in
protective clothing in 2014. Jane Ellis reports
maintaining the longevity of antimicrobial
systems such as coatings and silver
threads. The biggest challenge is in
finding ways to make the active ingredient
adhere to the garment or textile.
After forming a partnership with
Vestagen Technical Textiles of Orlando,
Baptist Health, a healthcare organisation
based in South Florida, US, invested in
staff uniforms and patient garments that
repel fluids to minimise the risk of
transmission of bacteria.
More than 30,000 pieces of staff
uniforms, lab coats and nursing scrubs
were distributed in phase one of the
project, in an investment of $1m. The
garments featured Vestagen’s Vestex
textile technology, which is said to have a
durable fluid barrier, an antimicrobial and
a special breathable material for wearer
comfort. More than 6,000 Baptist Health
staff with frequent patient contact
converted to the new uniforms during the
phase one distribution.
Sustainable options to deal with the
large number of single-use garments used
in the healthcare sector that end up in
landfill was another theme in 2014.
VWR, for example, launched its second
recycling service called Gown Up, Give
Back, which allows its US customers to
recycle single-use garments purchased
from the company and turn the plastic
waste into resin for use in permanent
infrastructure such as composite decking,
railway sleepers and drainage pipes,
thereby giving new life to their discarded
clothing.
The scheme provides a waste collection,
shipment, and recycling solution for most
single-use garments as long as they are
free from contamination and were
purchased from VWR.
Other projects announced during the
year tackled sustainability in garment use
via different approach.
A joint research project by the
Hohenstein Institute and the wfk
(Cleaning Technology Institute e.V.) is
investigating the development of reusable
operating theatre textiles that are more
comfortable to wear and, at the same
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CLOTHING & PPE
time, more durable because they can be
cleaned using a gentler process.
The project is sponsored by the Alliance
for Industrial Research and will run until
the start of 2016. Both project partners
are complying with the requirements of
the European Commission’s Closed Cycle
and Waste Management Act (KrWG).
The KrWG, as implemented in the
Waste Framework Directive RL
2008/98/EC, has been part of German law
since 2012. The reform states that to
avoid waste, materials should remain in
the production cycle for as long as
possible. However, in the healthcare
sector, especially in hospitals, the trend is
in the opposite direction. In the interests
of ease of handling and guaranteed
sterility at all times, as well as cost, the
proportion of disposable clothing used in
hospitals is increasing all the time.
The resulting waste amounts to about
3.2kg of textiles for each patient per day
that have to be disposed of correctly,
equating to an annual 1,200kg mountain
of waste for every hospital bed.
Medical textiles such as bed covers and
operating theatre clothing are classed as
licensed medical products and are subject
to various textile technology requirements
under the European DIN EN 13795
standard. These include mechanical
resistance, microbiological purity and a
barrier effect against fluids.
To offset the relatively high cost of
reusable protective clothing, it must be
able to withstand about 50–70 cycles of
use and reprocessing. Consequently, the
wearing comfort of reusable textiles
always suffers – yet comfort is precisely
the characteristic for which, in addition to
environmental performance, they are
superior to disposable textiles.
Gloves and goggles
The global disposable gloves market is
expected to reach $7.85bn by 2019,
growing at a CAGR of 6.2% from 2013 to
2019, according to a report from
Transparency Market Research. The
market was worth $5.21bn in 2012 and in
volume terms accounted for more than
200 billion pieces.
The report, Disposable Gloves (Natural
Rubber, Vinyl, Nitrile and Others) Market
for Medical and Non-Medical (Food,
Cleanroom, Industrial and Other)
Applications – Global Industry Analysis,
Size, Share, Growth, Trends and Forecast
2013–2019, said increased healthcare
spending and growing non-traditional
end-use industries in the emerging
economies of Asia Pacific and Latin
America will boost the market over the
Goggle trends in general include designed using more flexible materials and with better venting options to
improve comfort and encourage use
next four years, but volatile raw material
price and currency fluctuations could
hamper market growth.
North America was the market leader
in 2012, accounting for 42.3% of global
demand, but the US market is relatively
saturated and other regions are likely to
see comparatively stronger growth.
Europe, the second-largest consumer of
disposable gloves, is expected to grow at a
CAGR of 5.4% over the forecast period.
Asia Pacific, riding on the high growth
in countries such as China and India, is
expected to be the fastest-growing market
in terms of volume over the next four
years. This region accounted for 15.3% of
the global market for disposable gloves in
2012 and is expected to grow at a CAGR of
6.7%.
Meanwhile, Frost & Sullivan’s Analysis
of the Asia-Pacific Disposable Gloves
Market noted that the frenetic pace of
economic growth in Asia-Pacific combined
with a thriving healthcare sector,
particularly in southeast Asian countries,
has provided a major boost to demand for
these gloves; the market reported revenue
of more than $309.8m in 2013, and is
estimated to reach $435.7m by 2018.
Countries such as Thailand, Malaysia
and Singapore have emerged as medical
tourism hubs and this growth, along with
the large populations in these countries,
has augmented the demand for medical
disposable gloves, which constitute at
least 50% of the total number of
disposable gloves sold globally.
While the disposables sector of the
gloves market appears to be set for
growth, in other areas it was a quiet year
for product launches.
New products from Nitritex included
isolator and Restricted Access Barrier
Systems (RABS) sleeves and gauntlets for
use in highly controlled environments.
BioClean BarrierPlus Sterile Gauntlets
are available in lengths of up to 840mm
(33in) and three port sizes from 150mm to
300mm (6in to 12in); BioClean
BarrierPlus Sterile Sleeves are available
in lengths of up to 660mm (26in), and are
suitable for port sizes from 150mm (6in)
to 300mm (12in); while BioClean
BarrierPlus Mittens, a cost-effective
alternative to gauntlets, are available in
lengths of up to 840mm (33in) and
suitable for port sizes from 230mm (9in)
to 265mm (10.5in).
In goggles, the trend is to provide
greater comfort. Scott Safety, for example,
used flexible, comfortable materials and
anthropomorphic data to revamp its
product range, optimising the shape and
size to ensure a secure fit for a range of
users. The new models also offer a variety
of material and venting options to improve
comfort and encourage use.
Four additional models – Luna,
Graviton, Bora and Neutron – were added
to the range, which now includes a variety
of goggles to protect against impact,
chemical splash, UV and IR radiation.
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January 2015
53
CONTAINMENT
Isolators, glove boxes and downflow
booths remain at the heart of the
containment sector and continue to evolve
to provide greater protection, convenience
and cost-effectiveness.
UK containment specialist Extract
Technology recently supplied a multichamber advance cell therapy isolator to a
new research and manufacturing facility
in the Czech Republic. The seven-chamber
isolator incorporates full process
integration of incubators and microscopes
within a grade A laminar flow
environment, dedicated chambers for
process separation, different pressure
regime control within each chamber and
an integrated hydrogen peroxide system.
The Czech Republic facility for
regenerative medicine and tissue
engineering now boasts one of the most
advanced cell therapy isolators on the
market. It will minimise human
interventions in processing areas,
significantly reducing the risk of
microbiological contamination from the
environment.
The same company also supplied two LS
Downflow Booths to Johnson & Johnson
Pharmaceuticals in Shanghai, China for
the manufacture of over-the-counter
medicines. The containment criteria was
100μg/m3 and the booth design
requirements included 1.8m safe work
zone, stainless steel construction, three
stage filtration and on-board coiling to
offset heat gain.
Spanish company Telstar’s Aeolus
laminar flow cabinets claim to offer 20%
more working area in an ISO 4 sterile
environment. The cabinets are suitable for
handling non-pathogenic samples in
applications related to hospital protocols
and clinical pharmacy, in vitro
fertilisation, food quality control and
microbiology, in vitro cultivation of plant
and animal cells, microbiology and
cleanrooms for pharmaceutical, veterinary
and food industries, as well as hospitals,
universities and research centres.
The laminar flow system enables work
to be carried out under sterile conditions
with low particulate count by virtue of a
continuous filtered air sweep in the work
area. An automatic airflow velocity control
system ensures an optimised protection
level for the product, an appreciable
reduction of sound level and 20% more
sterile working area while maintaining a
compact external footprint.
Engineers at Hosokawa Micron
engineers have manufactured a recordbreaking 11-metre wide downflow booth
that encapsulates eight IBC filling
stations and was engineered to suit the
CONTAINMENT COMES IN
ALL SHAPES AND SIZES
Containment systems come in many shapes and sizes – from
modular room-sized units for use with whole suites of equipment,
down to small bench-top units. Hilary Ayshford looks at recent
developments at both ends of the scale
layout and available factory space. The
booth’s open-fronted design uses no
vertical supports, offering unrestricted
operator access into the booth and to the
filling stations, which makes for easy
transfer of IBCs.
Offering a safe working zone for
operatives, the downflow booth uses
HEPA filtered air to push dusts or
vapours down and away from the
operators’ breathing zone, creating a clean
processing zone that is a safe and more
user-friendly alternative to wearing
personal protective equipment. The
filtration system can be accessed either
from inside or from the rear of the booth.
Operator protection
The company also has responded to
industry demands for improved levels of
personnel and product protection by
developing a range of modular downflow
booths capable of delivering operator
exposure levels (OEL) of <1μg/m3. The
booths also provide product protection by
creating a ‘clean processing zone’ to
minimise cross contamination risk from
other products or processes. Their costeffective yet flexible
modular design makes
them suitable for a
range of applications
when it is necessary to
undertake processing
steps outside a closed
food processing
machine, such as
sampling, filling or
packing operations.
The booths are
designed to deliver a
quick and costeffective route to
contained processing
and operator
protection – without
Hecht’s Proclean
single-use isolator
system can handle
potent APIs and
reduces cleaning
costs
the need for restrictive PPE equipment.
They deliver a unidirectional flow of air
forced downward through ceiling mounted
distribution screens in a vertical, laminar
flow. This suppresses the elevation of dust,
taking the dust away from the operator’s
breathing zone and into the booth’s low
level perforated extraction grilles.
Greater accessibility
UK-based Bigneat developed a new style
of safety workstation called Optiflow,
featuring a recirculatory filtration fume
system that offers consistent airflow and
ensures the integrity of the ‘working safezone’ while providing unhindered
accessibility. Optiflow is a bench-mounted
ductless fume cabinet that provides
unrestricted access for procedures and
difficult to perform operations within a
standard fume cabinet.
For applications where multiple mills,
micronisers or air jet mills are required
for a single product or process, Powder
Systems (PSL) has devised the multiple
mill isolator, which can accommodate
different mills in a single glovebox. The
Universal Multiple Mill Glovebox offers
Cleaners & Sterilants
Airborne Decontamination
Microfiltration
56
January 2015
CONTAINMENT
the advantage of a nitrogen-purged
environment, nanogram containment, a
small area to clean and better control over
cross-contamination. The glovebox
features an L-shaped window with good
access for changing, stripping and
cleaning mills within the glovebox. Due to
the explosive nature of milling and
micronising, an assured explosion
protection system is fully integrated into
the design, with PSL’s nitrogen purge
systems able to achieve less than 1% RH.
TAP Biosystems (now part of the
Sartorius Stedim Biotech Group), a UKbased supplier of cell culture and
fermentation systems, developed for a
major pharmaceutical company a stainless
steel version of its Fill-it system, designed
for safely dispensing biohazardous
materials such as vaccine stocks. It fits
into standard isolator cabinets, thus
reducing the product contamination risk,
as well as the operator’s exposure to
biohazardous material.
The system automatically decaps, fills
and recaps a rack of 24 x 2ml vaccine vials
every two minutes. This ensures vial-tovial consistency and makes routine vial fill
and finishing safer. Each vaccine batch is
aseptically processed using GMP-certified,
single-use tubing. The stainless steel
exterior of Fill-it can be sterilised after
each batch run with high strength
hydrogen peroxide vapour, further
reducing product contamination risk.
Single-use flexibility
The biotech industry pioneered the use of
single-use equipment and has shown that
it works well in an industrial setting. An
increasing number of companies are
looking at the disposables route because it
offers the opportunity to reduce
production and cleaning costs and the
issues of production residues and cross
contamination no longer come into play.
Hecht Technologie has designed and
built a number of single-use systems that
combine the advantages of isolators with
the benefits and flexibility of plastic
liners. In co-operation with Hosokawa
Alpine, Hecht has developed the world’s
first manufacturing process in a
disposable system, in which APIs can be
micronised with the support of a
disposable air separation mill.
Safe fluid transfer
Another of the year’s innovations
involving single-use disposable
components to increase operator safety is
the AdvantaPass cleanroom wall passthrough technology for transferring
critical fluids during pharmaceutical and
Major improvements in
containment
technologies allow the
use of a single,
compact and mobile
isolator to integrate a
full aseptic filling line
for potent materials.
The product is
protected from
bacterial agents, the
operator and
environment remain
safe and operating
costs are lower than
cleanroom facilities.
This dual isolator from
Powder Systems Ltd
(PSL) was designed
for high containment
and aseptic processes
and has a compact
and mobile design
with low utility
consumption
biopharmaceutical production.
It combines single-use tubing and
isolation chamber assemblies to offer a
practical, safe, secure and easy way to
move large volumes of liquids from one
room to another while maintaining
separate atmospheres and minimising the
risk of cross contamination.
Manufactured by AdvantaPure, the
sanitary products division of US-based
NewAge Industries, it is said to be the
first system of its kind to offer complete
isolation between manufacturing
environments when transferring multiple
lines of fluid through a single wall portal.
It conveys fluids without having to move
bins and totes, thereby removing the risk
of breakage, spillage and lost
pharmaceutical product associated with
bin transfer. The system was recently
granted a US patent.
The QCS 150 Pass-Through autoclave
from Priorclave is the company’s latest
and smallest double-door autoclave
designed to enable laboratories to
maintain a secure sterile path for media
and waste as it passes in and out of a
sealed laboratory.
The highest level of door interlock
settings prevents doors on either end of
the chamber being opened simultaneously.
All sterilising processes are controlled by
the advanced Tactrol 2 microprocessor,
which provides simple yet variable
settings of process time and temperature,
all supported by graphic indication of cycle
status. Operation is fully automatic once
the cycle has begun.
There are two versions of the Priorclave
QCS 150 Pass-Through: a 150L
electrically heated version and an
externally steam heated design, each
offering cooling and automatic timed freesteaming. A microbiological filter can be
fitted where there is concern about biohazardous material in the autoclave.
Unfiltered condensate is returned to the
autoclave for sterilisation.
Demand for small modular facilities,
whether for manufacturing in a controlled
environment or containment of
transmissible diseases, was strong again
in 2014. Connect 2 Cleanrooms developed
Rapid Room, a low-cost and quick-toinstall modular cleanroom system.
Demand from the global medical device
industry for ultra-high quality medical
devices is driving organisations to seek
cost-effective and prompt solutions to
contamination control for all stages of
device production; from manufacture and
assembly to inspection and packaging.
The Rapid Room, available through
Cleanroomshop.com, has a 1.8 x 1.8m
footprint, can be installed in 30 minutes,
and meets ISO Standard 14644-1 Class 7.
Disease containment
Meanwhile US company G-CON
Manufacturing has expanded its portfolio
with the launch of a transmissible disease
containment POD. The TDC POD is 8.5ft
wide, allowing it to be transported by
tractor-trailer or its own axle system. It
features double bag-in/bag-out HEPA
filters and is equipped with its own
generator unit. It can be cleaned using a
number of methods, including vaporised
hydrogen peroxide or chlorine dioxide.
Each POD can hold a number of
patients and equipment in a larger area.
G-CON Manufacturing is planning further
POD developments, including mobile
surgical suites.
The new standard in
Cleanroom technology
Integrity® Cleanroom offers an extensive range of high quality cleanroom
consumables, developed to meet industry’s needs.
With an established product range and an unrivalled customer service ethos,
Integrity® Cleanroom consumables have been applied in the medical,
automotive, defence, aerospace and electronics industries.
To see how Integrity® Cleanroom can deliver award winning solutions for you,
speak to a member of our sales team or visit our website.
www.integrityproducts.co.uk | +44 (0) 1473 836 205
Stationery
Tacky
Wipes
Apparel
Cleaning
Disinfectants
Facemasks
Gloves
Pharmagraph
Pharmagr
aph enVigil-PnP Monitoring System
Demonstrates
Demonstr
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cleanrooms
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operations. With a range of package sizes supporting up to
20 particle counters, 100 active air samplers and up to 160
environmental inputs enVigil-PnP is easy to deploy, verif y
and validate.
enVigil-PnP is provided with an over view menu with status
indicators, trends, alarms, data logging, reports and data to
MS Excel. Optional modules are also available to support
instrument tracking, batch reporting, network view nodes,
OPC ser ver and GSM modem support for data on alarm to
email and SMS text.
forr isolator gassing operations
enVigil-PnP offers support fo
and particle counter “swap-ability” in order to minimise
system downtime due to contamination failures. If you do
not require particle counting then enVigil-PnP offers a low
cost version for environmental or viable (active air sampling)
monitoring only.
Installation and Operational Acceptance Test Protocols
allowing the enVigil-PnP system to be easily designed,
Pharmagraph
Pharmagr
aph enVigil-PnP Monitoring System
Scalable,
Scalable, modular solution
Pha mag aph s mon o ng sys ems can s a sma sav ng
n a nves men hen sca e up as he ac y g ows bu d ng
on ex s ng ha dwa e and mon o ng senso s and p ov d ng
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Printed on 05-Aug-2011Monitoring
Audit Log Report
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PnP Drying Monitoring
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Drying Monitoring
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Room
Temp
Signature:
:
Start Date/Time
01-Jan-2011
Printed on 05-Aug-2011
Signatures:
Name:
Tag/ID
:
Descriptor
Pharmagraph
Start Date/Time
04-Jun-2011
-
Title:
:
100
Date:
:
Title:
:
1
50
40
Date:
:
80
00:00:00
31-Jan-2011
Page 1 of
1
End Date/Time
13-Aug-2010
of
60
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Signatures:
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Signature:
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Title:
30
20
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Page
120
at 10:24:42
Printed on
05-Aug-2011
at 10:27:06
: :
PnP Drying Monitoring
ENV_6_1
Room RH
Units
degC
%RH
04/Jun/11
00:00:24
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:
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Page 1 of 1
10:24:26
End Date/Time
26-Jul-2011
04-Jun-2011
01:00:00
: :
Start Date/Time
End Date/Time
27-Jul-2011
10:24:26
[email protected]
a es@pharmagrapo.
h c .uk
www.pharmagraph.co.uk
www.pharmagraph.co.uk
60
January 2015
DISINFECTION
With the outbreak of Ebola in parts
of West Africa and the continuing concern
over hospital-acquired infections, it is
little wonder that demand for cleaning
and disinfection products continues to
grow. According to a report by the
Freedonia Group, world demand for both
industrial and institutional cleaning
chemicals will increase by 4.3% each year
to US$46.3bn in 2018. Disinfectant and
sanitiser sales will be particularly strong;
however, Freedonia also predicts a rise in
demand for speciality biocides in the US
by 3.9% a year to $4.3bn in 2018, as a
result of improving economic conditions,
coupled with a rising emphasis on
improved sanitation in production
processes and workplaces.
Several disinfectant products were
launched in 2014. UK-based MTP
Innovations’ DiffX disinfection product is
a powerful non-chlorine disinfectant that
is said to eliminate all surface
contamination, including C. Difficile
spores, MRSA, bacteria and viruses. DiffX
has been shown to continue to act despite
the presence of organic material that
inactivates many other disinfectants, says
MTP. It is supplied as a powder in a
soluble sachet, aiding dilution control and
ensuring that cleaning staff do not come
into physical contact with the substance.
Another novel dispensing concept was
launched by Redditch Medical in the form
of a burstable pouch system in which the
mop or wipe is separated from a sporicide
by a frangible layer until the point of use.
Applying pressure to the pouch ruptures
the membrane and allows saturation of
the wipe with a precise volume of liquid.
Kimtech WetTask dual-performance
wipes from Kimberly-Clark Professional
have a white side for regular cleaning and
a purple, textured side for hard-to-remove
substances. The physical act of scrubbing
removes a large number of microorganisms and visible soils from surfaces,
the company says; after cleaning,
attention can be turned to disinfecting.
Ecolab’s new non-sterile surface
cleaning and disinfection product, Incidin
Pro, cleans and disinfects surfaces in one
step and combines antimicrobial efficacy
with short contact times, making it
suitable for use in isolated low grade (C &
D) cleanrooms and adjacent outer areas.
The product’s compatibility with a
variety of materials, including metals,
ceramics and plastics, helps avoid surface
corrosion, while the omission of
ingredients such as fragrance and
aldehyde improves user safety.
Tristel launched a fast-acting sterile
sporicidal disinfectant suitable for use in
The InSpec wipe and sporicidal agent can now be
combined in a two-part pouch; one side for the dry
wipes, the other for the sporicide solution. After
activation sporicidal efficacy is retained
INFECTION CONCERNS
FUEL DEMAND FOR
CLEANING SYSTEMS
AND MATERIALS
Cleaning and disinfection systems remain at the front line of the
battle against hospital acquired infections. Hilary Ayshford
summarises the major developments in 2014
all grades of cleanroom. Crystel Titanium
is sporicidal in 60 seconds, non-corrosive
and can be used on all hard non-porous
surfaces.
But the frequent use of powerful
cleaning chemicals can take its toll on the
fabric of buildings and on expensive,
sensitive equipment. A joint project in the
US between the Austen BioInnovation
Institute and Omnova Solutions, both
located in Ohio, aims to explore the
interactions between disinfectants and
common health facility surfaces, with the
goal of developing solutions that minimise
the risk of infection while safeguarding
physical assets. The project involves using
Omnova’s PreFixx protective coating in
healthcare applications and analysing
which surfaces, cleaning products and
cleaning methods are the most effective in
disrupting the transmission of HAIs.
This hidden contamination risk was
behind the development of Bayer
MaterialScience’s robust wall coating. The
high durability (HD) polyurethane coating
technology has markedly better resistance
to scrubbing with disinfection chemicals
such as strong bleach solutions, hydrogen
peroxide and quaternary ammonium salts.
The matrix of the new HD coating
consists of polyurethane. It is formed by
reacting a water-based hydroxyl polyacrylic dispersion with a water-soluble
isocyanate molecule with very high
reactivity, crosslinking the components
very densely with one another, to form an
extremely tough and durable surface.
Another antimicrobial surface coating
shown to reduce hospital pathogens is
Allied BioScience’s SurfaceWise. The
invisible coating binds to surfaces at a
molecular level, forming a protective
shield that creates a hostile microscopic
environment for pathogens.
Research centres worldwide have been
conducting tests on the latest disruptive
technology from Nanotouch Materials in
the US. NanoSeptic has been the subject
January 2015
61
DISINFECTION
of extensive testing against a variety of
pathogens. The latest test by an
independent FDA-compliant US lab
showed that the NanoSeptic surface
eradicated the human Coronavirus in less
than 30 minutes. The NanoSeptic selfcleaning surface products include door
push pads and handle wraps, portable
mats for counters, tray tables and
bathroom fittings.
Meanwhile, hospitals around the world
are increasingly adopting antimicrobial
copper equipment to reduce the spread of
infections via frequently-touched surfaces.
Items benefiting from copper’s natural
antimicrobial activity range from desks
and keyboards, to toilet and shower grab
rails, door handles, toilet seats, light
switches and taps.
It is probably even more important to
ensure that strict hand hygiene regimes
are observed. According to Frost &
Sullivan, the value of the hand hygiene
market in Western Europe is estimated to
reach $680.8m by 2018. Alcohol-based
hand rubs are expected to become the
most popular solution in the hand
disinfectant and surgical hand antisepsis
segments owing to their proven efficiency
and ease of use.
Adoption of hand hygiene compliance
monitoring (HHCM) devices in hospitals
is improving compliance levels markedly,
the company says, and predicts a host of
opportunities as automatic HHCM
technology is integrated with most
automated and manual dispensers to
become a standard across all hospitals in
the next five to seven years.
For example, the OhioHealth group of
hospitals in the US is working with IBM
to help stop the spread of hospital
infections using a network of wireless
sensors and real-time Big Data analytics
that measure hand-washing practices. The
pilot project in Columbus has already
achieved more than 90% compliance with
hand-washing standards – a 20% increase
over its previous practices and well above
the 50% national compliance level.
Meanwhile, the Joint Commission
International (JCI), a US-based quality
accreditation organisation, is providing a
Targeted Solutions Tool (TST) for hand
hygiene to help reduce healthcareassociated infections. The online tool has
been tested by JCI-accredited healthcare
organisations in Asia-Pacific, the Middle
East and Europe, and pilot results showed
a 72% improvement in hand hygiene
practices.
Ecolab’s Nexa hand hygiene dispensing
platform, which will be available in
Europe in Q1 of 2015, is said to make it
easier to promote good hand-washing
practices. The Nexa platform can dispense
a number of Ecolab hand hygiene
products, including liquid and foam hand
soaps, lotions, hand sanitisers and body
shampoos, all from the same unit.
Nexa’s design offers easy product
identification through optional colourcoded badges and language-free icons;
adjustable dosing; compact dispensers;
better inventory management through the
ability to hold both large and small
product bottles; less waste through
patented pumps that dispense up to 99%
of product; and greater sustainability
through the use of recyclable materials.
UV disinfection
Ultraviolet light has become increasingly
popular as a method of sanitising hospital
surfaces, and even entire rooms. The
Women’s Hospital in Newburgh, Indiana
is using a V-360+ UV Room Sanitizer
from UltraViolet Devices to provide
surface disinfection. The
V-360+ is a mobile germicidal irradiation
device that generates high intensity UV
energy and quickly disinfects
contaminated surfaces.
UV is also used in the Aerobiotix T1 Air
Disinfector-Recirculator, a mobile unit
designed to be used in enclosed spaces
that require a significant reduction in
airborne microbial load. Marketed by USbased Aerobiotix, the system rapidly
draws in contaminated room air,
inactivates airborne viruses, spores and
bacteria via an internal UV field, and
recirculates the cleaned air.
Similarly, UK HVAC specialist E-CO has
launched a disinfectant product that can
be installed and fitted flush to the ceilings
of individual rooms. It shines UVC light
on surfaces, sterilising them and reducing
the spread of pathogens.
Royal London Hospital has been
piloting an innovative infection control
solution with integrated support services
company Carillion. The six-week pilot
featured a UV-C light triple tower
technology system. The system involves
placing three articulating UV-C towers in
a patient room, which is equipped with
laser validation to ensure the area is
completely covered during a 30-minute
process. The technology allows all areas of
the patient environment to be disinfected,
overcoming obstacles such as shadows and
distance that are inherent issues with
using single-emitter UV-C systems.
A medical centre in North Carolina in
the US has demonstrated that the
PhotoxAir purification system
significantly reduces airborne bacteria in
Hospitals are increasingly adopting antimicrobial
copper equipment to reduce the spread of
infections via frequently-touched surfaces
clinical trials conducted in an emergency
department setting. PhotoxAir treats
indoor air with a proprietary Photocatalytic Oxidation process that uses a
fibrous mat material coated with titanium
dioxide and platinum, which is then
exposed to UV light. Air is sent through
the fibrous mat where multiple catalytic
sites adsorb airborne bacteria found in the
air. The catalyst is photo-activated by UV
light and the bacteria are oxidised and
destroyed on the catalytic surface.
Moving away from UV, Telstar’s ionHP
biodecontamination system for use in
pharmaceutical aseptic enclosures
increases the effectiveness of the
decontamination process and reduces
degradation of construction materials by
virtue of requiring a very low
concentration of H2O2, the Spanish
company says. IonHP requires a
significantly shorter decontamination
process time and has no requirement for
special atmospheric conditions, which
eliminates the need for air conditioning
units, thereby reducing equipment cost.
UK-based AMSBIO’s purpose-built
compact ozone gas generator, the Ozilla,
will fit in most standard laboratory cell
culture incubators, air incubators, cell
culture hoods, PCR hoods, or other
environment where a sterile atmosphere is
critical. It is able to eliminate airborne as
well as surface contaminants. A novel
‘scrubbing’ technology removes all ozone
gases at the end of each sterilisation cycle
by converting ozone gas back to oxygen.
Interview
INTERVIEW:
DR TIM SANDLE
In 2014, Dr Tim Sandle conducted a
disinfectant field trial in a UK
pharmaceutical facility. The field trial
examined two disinfectants manufactured
by Micronclean: Alpha and Beta
(Compliance 100® range). The
performance of the disinfectants was
examined over a 15 week period in three
different grades of cleanroom: EU GMP
grades B, C and D.
The trial assessed the numbers and
types of microorganisms found within the
cleanroom facility by contact plate testing.
Samples were taken prior to disinfection
and following disinfection.
Alpha is a broad spectrum hard surface
disinfectant with bactericidal and
fungicidal activity. Beta is a broad
spectrum hard surface disinfectant with
bactericidal, fungicidal and sporicidal
activity.
Micronclean recently spoke to Dr.
Sandle regarding the study:
Please describe the current best
practice approach to validation of
disinfectants for cleanroom use.
There are different approaches for the
validation of disinfectants, particularly
between the U.S. and Europe. Within
Europe there are a series of steps to be
followed. The process begins with a
suspension test, which measures the time
taken for the disinfectant to kill (or
inactivate) microorganisms. It is a useful
test, but arguably it does not represent
practical conditions. The next phase of
testing is more robust. This looks at how
the disinfectant works on different
surfaces in relation to the destruction of
microorganisms. This is useful for
establishing the contact time, and there
can be variations between different
surface materials. The third phase is the
field trial. This involves using disinfectants
within the controlled environment and the
efficacy of the disinfectant is assessed
through environmental monitoring. This
approach allows the disinfectant to be
assessed in terms of application
techniques and the frequency of
application: it answers the question “how
often should I disinfect my cleanroom?”
The field trial also allows for an
assessment of resistant strains to be
made, through the conducting of microbial
identifications.
Please describe the field trial that you
conducted with Alpha and Beta.
To examine the two products, a series of
cleanrooms of EU GMP grades D, C and B
(in ascending order of cleanliness) were
examined. The two disinfectants – Alpha
and Beta – were used to disinfect each
room on a weekly basis, with a rotation
pattern of 4 weeks of using Alpha followed
by 1 week of Beta; and then repeating the
pattern. To assess the performance of the
two products, surface samples were taken
(contact plates containing a
microbiological agar with neutralisers).
What conclusions were you hoping to
reach in conducting the trial of Alpha
& Beta?
The aims were to assess whether the
microbial counts decreased once the two
products were used and whether the
continual use of the products kept the
microbial counts at a low level. This was
very well demonstrated.
Another factor was to consider whether
any of the microorganisms recovered were
problematic in terms of their theoretical
resistance to the disinfectants (for
example , bacterial spores). Through the
course of the study, no resistant
microorganisms were recovered in high
numbers.
Interview
Caption: Beta’s non corrosive sporicidal action significantly reduces microbial counts
Please summarise the microbiological
data obtained in the Alpha and Beta
field trial and explain what this
demonstrated.
The microbiological data was of a low level
throughout the study. In each cleanroom,
when the study began the microbial
counts decreased and they remained
below the regulatory specified action
limits. The set-use of the Beta product was
needed to prevent any creep upwards, and
the more frequent use of the Alpha
product kept levels low. Using the two
products in tandem is necessary for
maintaining contamination control.
How did operators find Alpha and Beta
to use? (e.g. practicality, cleaning
efficacy, foaming, residue, odour, etc.)
Operators found the products easy to use.
The odours were not unpleasant (having a
standard ‘disinfectant smell’ which most
cleanroom staff are used to). The products
were low foaming and dried relatively
quickly. There were no noticeable
residues.
If you could summarise the Alpha and
Beta trial in a few words, what would
you say?
The use of Alpha and Beta together makes
for an efficient combination in terms of
reducing microbial contamination down to
a level below regulatory maximal values,
and for maintaining microbial counts at a
low level. The two products, in
combination, make for an effective
contamination control solution.
The study demonstrated that the use of
the Alpha and Beta disinfectants was
effective in reducing the overall level of
microbial counts as assessed from the
surface monitoring of three grades of
cleanroom (D, C and B). The pattern of
microbial reduction in each cleanroom
was similar. Because lower grade areas
tend to contain higher number of
microorganisms (such as a Grade D area
compared to a Grade B area), the
reductions are numerically greater.
However, when compared in terms of
percentage reductions the levels of
microbial kill are broadly similar.
The data also indicates that the
application of the disinfectant reduced the
level of microbial counts for each
application (as shown with the comparison
of pre- and post-disinfection
environmental monitoring data). Statistical
analysis showed the reduction to be
significant.
The data demonstrates that a rotational
regime using Alpha for four weeks
followed by Beta for one week kept each
of the cleanrooms in a state of control.
This is evidenced in relation to both
microbial counts and in terms of the
microbial profile, where there was no
build-up of resistant strains (the majority
of the isolates across both cleanrooms
were skin-based microflora).
On the basis of this field trial, the Alpha
and Beta disinfectants are effective for
contamination control in different grades
of cleanroom.
Quality
Qualit
ty Inno
Innovative
vativve S
Solutions
olutions
●
●
●
●
Roman Bank, Skegness,
Lincolnshire PE25 1SQ.
Tel 01754 767377. Fax: 0845 2992166
Email [email protected]
Web www.micronclean.co.uk
Web www.micronclean.eu
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66
January 2015
MICROBIOLOGY
Research is revealing more
information about microbes found on
humans and in the manufacturing
environment, changing the way
microbiological strategies and tests are
devised. Pharmig’s annual conference,
held in Nottingham, UK, highlighted some
areas where pharmaceutical regulators
have embraced these new concepts but
have not, as yet, mandated or specified
procedures in the standards.
Tim Sandle, Site Microbiologist, BPL
began the proceedings by looking at recent
research from the Human Microbiome
Project (HMP) and its implications for
cleanroom microbiology. Research on the
HMP has revealed that there are some
1,000 different species of microbes found
on men and women, and it is now
recognised that a human adult houses
about 1012 bacteria on the skin, 1010 in the
mouth and 1014 in the gastro-intestinal
tract. There is also a considerable
diversity of species and a variation
between individuals.
The skin is now regarded as an
ecosystem with different areas populated
by different species. Knowing what is
there is important because people can
shed as many a billion skin cells a day, and
up to 10% of those may carry on average
four microbes per skin cell.
Today, we can identify those microbes
through the use of genotypic techniques
(such as 16s rRNA genes in lysed
microbial DNA) and whereas previous
culture methods tended to detect
Microccocus spp., Staphylococcus spp., and
a low incidence of Gram positive rods, new
research indicates the prevalence of other
species such as: more Gram-negative
bacteria (Acinetobacter is the dominant
genus) under the arms and between toes,
more Gram-positive and anerobic bacteria
linked to arms and torsos, and more fungi
generally distributed all over the body.
For microbiologists concerned with
bioburden, this difference between what is
found in the cleanroom using culture
methods compared with what we now
know resides on most people poses the
question, is the media and its incubation
regime (time and temperature) suitable
for the recovery of the types of microbe
likely to be shed from the skin?
In the light of this, Sandle considered
various implications: Is there a need to
change environmental monitoring (EM)
methods? Is anaerobic or fungal
monitoring needed? Does the disinfectant
efficacy panel need expanding? Does
media growth promotion need to change?
What can be learned for micro data
deviations? And do the findings inform
MEETING REGULATORY
EXPECTATIONS
Best practise and meeting the expectations of regulators on the
use of plant isolates, bioburden strategies, rapid ID methods,
auditing environmental controls and deviation management are
topics taxing microbiologists. Susan Birks reports on these and
other issues discussed at the recent Pharmig conference
about gowning practices?
One of Sandle’s conclusions was that
culture-based methods remain useful as a
spot check for indicators of cleanroom
contamination as they pick up enough
species to show a trend. However, EM may
need to be adjusted for anerobic microorganisms, and given the relatively high
levels of Propionibacterium spp. associated
with hair follicles, he suggested, this is
particularly relevant where nitrogen gas
or compressed air lines are used as part of
the filling process and have contact with
the product.
The findings also have a bearing on
disinfection studies. Perhaps consideration
should be given to broadening the ‘test
panel’ and checks made as to which
species are most resistant, he said. In
terms of trending, it may be advisable to
review efficacy of cleaning and disinfection
regimes to check whether spore-formers
or Gram-negative species are surviving.
Finally, there were also considerations for
gowning, e.g. should more be spent on
undergarments?
Chris Wells, Director, Global Key
Accounts at bioMérieux, spoke on the use
of plant (facility) isolates in QC testing
and pharmaceutical microbiology
validation. Increasingly, pharmaceutical
companies are including their own isolates
in the battery of micro-organisms that are
used for media growth promotion testing
and validation studies. These are wildtype strains isolated during EM, sterility
and bioburden testing, and routine testing
for contamination or spoilage.
Some industry commentators, however,
point out that compendial methods do not
currently mandate such an approach,
while others have challenged the merit
and practicality of their use.
Despite their use being optional, Wells
January 2015
67
MICROBIOLOGY
said more ‘challenge testing’ was being
carried out to check if disinfectants are
working. He said that there was ‘a
perception’ among large pharma
companies that regulators in the most
developed markets expect the use of plant
isolates despite the lack of definitive and
clear guidance on what is required. In the
past 10–15 years some 10 or more
companies were cited in 483 warning
letters for not using wild isolates, said
Wells. Their use was also driven by an
aspiration towards best practice or
corporate edict, he said.
While many companies currently select
two (or more) of their high frequency
isolates based on annual review of EM
data (reassessed annually) there is no
correspondence between common plant
isolate species and those prescribed by
Pharmacopoeial methods, raising
questions about the relevance of
prescribed strains, said Wells.
Patrick Nieuwenhuizen, Manager, QC,
Genzyme, suggested ways of improving
cleanroom behaviour, aseptic practices
and operator understanding so as to avoid
regulatory observations. Cleanroom
training is key but tuition is also needed
to ensure operators understand the
microbiology principles behind
cleanrooms, such as: why they are cold,
the difference between bacteria and
viruses, why there is a pressure
difference, the difference between
cleaning and disinfection and why it is
important. Even the rationale of using a
triple bucket is important and needs to be
explained to the non-microbiologist, he
suggested.
To avoid regulatory observations, he
advised cleanroom personnel training
should include – in addition to an
introduction to basic microbiology –
courses on contamination control,
cleanroom behaviour, hand washing,
gowning qualification, process simulations
and media fills (if applicable).
Operator performance is strongly
related to environmental excursions, he
said. According to research, some 95% of
excursions reported contained microorganisms from human origin and 85% of
root causes were attributed to inadequate
aseptic handling/behaviour (Figure 1).
When training in aseptic techniques it
is useful to have somewhere that
operators can practise. Similarly, specific
training should be carried out to
demonstrate proficiency in handling
media fills, and both should be under the
supervision of a trained microbiologist.
Because training is quickly forgotten
and old habits creep in, Nieuwenhuizen
suggested the need to develop a learning
culture around cleanroom behaviour by
having weekly communications and team
meetings: ‘Get the right people involved
and explain what the microbiologists
found, why it is an issue, and what can be
done to correct it.’ Thereafter,
communicate what the outcome was and,
importantly, appreciate the input
provided, he added.
Audit planning
Elaine Doyle, Senior Compliance Auditor,
Abbott, looked at environmental controls,
audit planning and writing audit
observations. Doyle produced a long
checklist of questions for use when
auditing suppliers, such as: what
regulations they use, what they produce,
ask to see quality documents, identify
their sites and product portfolio;
determine the scope of outsourcing,
identify significant changes to sites or
quality systems (such as redundancies or
change in site management), review the
audit /inspection history of the site,
request and review applicable procedures,
determine the scope of utilities, for
example, do they use compressed gas?
In addition, she suggested requesting
and reviewing the list of nonconformances and out of spec (OOS)
investigations, any applicable quality
agreements, where contract services and
testing are utilised, and how they notify of
any changes (e.g. by letter, e-mail, etc).
Figure 1: Cleanroom Flora Distribution.
Slide courtesy of Patrick Nieuwenhuizen
(Genzyme, a sanofi company)
Operator performance related to
environmental excursions?
• 95% of excursions reported contained
modus operandi from human origin
• 85% root cause attributed to inadequate
aseptic handling / behaviour
Doyle said that many citations arise
because sites are not carrying out
processes as documented in their own
SOPs, so ask to see trend data, look at
temperature and humidity controls – do
they have alarms? are they validated? Has
there been a pattern to excursions and
how was it dealt with? To simply write on
the investigation ‘additional training’ is
not sufficient, she said. Ask whether there
is any evidence to show it has improved.
Finally, data integrity is another big
cause of citations, she said, so verify
computer systems that support the control
of facilities.
Alan Whipple, Microbiology Director,
Product Quality at GSK UK, looked at
deviation management and identification
(ID) of isolates. As technology has
improved, rapid methods mean that an
initial ID can be carried out quickly – but
be wary of rushing to management to
announce the initial findings, Whipple
warned, as certain statements could
persuade non-microbiologist managers to
stop production when it may not be
necessary.
He suggested that before rushing to
fully identify an organism the
microbiologist should ask: Is the isolate
likely to present a risk to product quality
or product safety? Is there a regulatory
expectation to identify? And is it useful to
know the potential source?
For some situations the need to identify
is clear such as OOS results in product
tests (sterility/microbial limit testing),
Grade A (and B) recoveries in aseptic
processing environments or action level
excursions in water and EM. But think
carefully before identifying other isolates
he said. ‘To comply with expectations you
don’t need to identify every organism.’
He added that traditional methods have
their uses. For example, he suggested that
a Gram stain can be used to identify a
likely source. However, the risk of
microbial proliferation needs to be
understood – e.g. some bacteria in
aqueous product should ring alarm bells.
‘Look for developing trends, such as an
increase in spore formers or moulds...and
make causative links,’ he suggested.
The difficult question is how far to take
the identification. Whipple said: ‘We don’t
always need to go to species level ID’. His
reasoning was if you give an organism a
species name, you need to be prepared to
assess and document the risk and impact
of that micro-organism.
‘Identification to species level is both
prone to inaccuracy and potentially
expensive,’ he added, and so should not be
attempted where it is not required.
68
January 2015
MICROBIOLOGY
What is always important is that risk
assessments are documented in a way that
a non-microbiologist (doctor or layman)
can understand the risk.
Mary-Anne Weatherhead, a Qualified
Person (QP) and a microbiologist at Pfizer,
discussed the QP’s role and how
microbiologists can build partnerships
with them. She looked at the duties of a
QP, key considerations for QP decision
making, how the microbiologists can help
the QP and why it is important for more
microbiologists to become one.
Part of the QP’s role is to ensure that
each batch of product has been
manufactured in compliance with national
requirements and Marketing
Authorisation (MA), and that each batch
imported from outside the community has
undergone in the EU full qualitative and
quantitative analysis of the active
constituents, and all other tests to show
compliance with the MA.
QPs and microbiologists are often key in
contamination investigations and in such
an event, the QP will want to know the
scope, impact, immediate actions taken,
root cause, corrective and preventive
action plans (CAPA), and will want to
have an overall summary.
‘Remember QPs are mutually
responsible,’ she said and so when
meeting them, as well as a clear summary,
bring back-up information to answer all
questions, trend information, details of
microbe identifications, and your idea of
what should happen next – otherwise the
QP will come up with ideas of their own.’
She also urged more microbiologists to
become QPs: ‘A time bomb is ticking, as
more QPs are retiring than qualifying,’
she said. In the UK, there are more
chemist and pharmacist QPs than
microbiologists. She added that having
more microbiologists QPs would give the
microbiology community greater influence
over quality procedures and regulation.
A bioburden control strategy
When designing a bioburden control
strategy, Dr Kevin Wright, Principal
Scientist, Microbiology, Procter & Gamble,
UK suggested prevention is better than
cure. Unfortunately, for many producers
(personal care, food and pharma) the
bioburden risk is increasing. Wright gave
many reasons why that is, including
increased use of natural raw and
biodegradable materials, as well as use of
milder formulation chemistries and fewer
preservatives.
All these trends together can increase
the risk to the consumer via (undesirable)
usage habits, and to product quality.
Pharmig Cleanroom Action Group initiated
At its November annual conference Pharmaceutical Microbiology Interest Group
(Pharmig) initiated plans to create a Cleanroom Action Group (CAG) to discuss and
formalise best practice in cleanroom procedures.
The aim is to collate best practice across many aspects, such as cleaning, gowning and
environmental monitoring, where currently none is available.
Cleanroom practice is constantly evolving and standards, regulators and facility
inspectors often specify the requirement for best practice but without specific guidance or
a benchmark for companies to compare.
Pharmig is a non-profit making professional organisation that represents the interests
of those who have responsibility for, or work alongside microbiology within the
pharmaceutical, cosmetics and healthcare sectors.
At its annual conference delegates were invited to put forward particular areas of
interest where best practice is not clear.
Brian Hayes (Ipsen Biopharm) is leading the CAG as Chairman, with the group also
benefiting from the expertise of Pharmig Vice-Chairman, Dr Tim Sandle. Hayes outlined
the main aims of the group as:
1) To establish a common understanding of world class aseptic processing;
2) To work with like-minded professionals to gain common understanding of Best
Cleanroom Practice and provide the opportunity to learn from others;
3) To hold regular visits to cleanroom facilities and to discuss and share good cleanroom
and practices.
Both Hayes and Dr Sandle would like to see the CAG becoming a key influencing group
within the pharma industry and with regulators.
Hayes explained that within the pharma industry there was a need for a ‘safe’ noncommercial forum, ‘where like-minded industry professionals can discuss best practice
for all cleanroom activities, current hot topics and industry trends and updates’.
The ethos of the group was well received and 43 delegates cutting across the industry
have since joined.
To get involved visit the Pharmig website.
www.pharmig.com
Furthermore, the production facility is
warm and wet, providing the ideal
breeding ground for microbes. This means
there is an increased need for a clean raw
material supply chain, clean facility
design, in process and raw materials
monitoring and cGMP.
To enable an estimation of the
probability and severity of bioburden
relative to the consumer and product, he
suggested collation of data that: quantifies
how much bioburden is present (dose),
identifies if it is a pathogen or
environmental, and functionalises what
the potential risk of the bioburden is to
the consumer or product.
The best strategy is to build an
‘integrated bioburden control approach’
he suggested. This is already practised by
the food sector via the ‘Hurdle’ concept,
which looks to combine hostility vectors
during production – i.e. modified
atmospheres, antimicrobials, packaging
and surface pasteurisation. In FMCG, it
could involve use of hostile intermediates,
thermal cycling, HACCP, monitoring and
intervention, pasteurisation and kill steps.
He said changes in a facility’s bioburden
may be driven by various factors: changes
by the material supplier, changes in a
formulation to less hostile ingredients,
changes in equipment or process
improvement, or letting the outside in
due to engineering works. To improve
control, Wright suggested setting up
systems that alert to changes in quality
agreements with suppliers and inform of
plant changes and increased sampling,
and to communicate more with
formulators.
Joanne Spiers, VP, Quality Operations &
Regulatory Compliance, Catalent, looked
at how to carry out effective
investigations. As stated in CFR 21 Part
211.192, any unexplained discrepancy or
the failure of a batch, or any of its
components, to meet any of its
specifications, must be thoroughly
investigated whether the batch has
already been distributed or not, she said.
Investigations must extend to other
batches of the same drug product and
other drug products that may have been
associated with the specific failure or
discrepancy. A written record of the
investigation must be produced and
should include both conclusions and
follow-up actions.
January 2015
69
MICROBIOLOGY
‘Inspectors will ask to look at deviations
and will check to ensure you have made
corrective actions and are monitoring the
situation going forward,’ she said. ‘They
will also want to know the effectiveness of
those [corrective] actions.’
According to the MHRA’s annual
review, poor investigation of anomalies
has been top of the list of inspection
deficiencies for the past five years (see
table 1). As a result, the first rule of the
investigation process, she urged, is
document, document, document.
‘If it is not documented it didn’t happen
from the inspector’s point of view.’ The
document should include the ‘who, what,
where and when,’ she said, i.e. collect the
facts, work out the impact and risk; do a
root cause analysis and an impact
assessment, and document the CAPA and
their effectiveness.
Biofilm prevention
Dr Samantha Westgate, Perfectus Biomed,
looked at industrial biofilms – a
community of micro-organisms that can be
both mono or mixed species, and that
attach to a surface (or each other), encase
themselves within a matrix of
extracellular polymeric substances and are
then internally regulated by the inherent
population. In addition to explaining how
biofilms form and attach to surfaces, she
discussed the consequences of biofilm
contamination and management methods
to prevent or control biofilm formation.
Common misconceptions about such
microbes in water systems, she said, were
that ‘maintaining water temperature
above 80°C would kill all microbes’, that
‘ozone will eradicate them’ or that
‘microbes are present evenly throughout
the system’. Within a bacterial biofilm,
microbes can withstand temperatures over
100°C for 20 minutes, she said.
The costs associated with biofilms
include the corrosion of pipework (which
increases bacterial adhesion), a decrease
in pipe diameter, which decreases flow,
and shut down and cleaning costs, as well
as costs arising from lost product.
The best weapon against biofilm is
prevention, she suggested. This could best
be achieved via a well designed system;
multiple treatment methods at both ends
of the system; testing water coming into
the plant; and regular monitoring for
early warning signs.
Dr J. Mark Sutton, Technology
Development Group, PHE Porton, looked
at the difficulties of monitoring hydrogen
peroxide (H2O2) decontamination
processes using biological indicators (BI).
BIs comprise a preparation of a specific
micro-organism that provides a defined
and stable resistance to a specific
sterilisation process. Micro-organisms
widely recognised as suitable for BIs are
spore-forming bacteria, because these
micro-organisms are significantly more
resistant than normal microflora.
Geobacillus stearothermophilus, for
example, is commonly used for H2O2 (also
steam), Bacillus subtilis var. niger for
ethylene oxide, and Bacillus atrophaeus
for dry heat.
Sutton discussed the shortcomings of
existing Geobacillus stearothermophilus
BIs and discussed research that suggests
some microbial organisms, such as MRSA,
as well as biofilms are a greater challenge
for decontamination with H2O2 than are
Geobacillus BIs.
He went on to talk about the
TABLE 1: MOST FREQUENT DEFECT CATEGORIES OBSERVED IN THE
MHRA 2013 REVIEW OF GMP INSPECTIONS
Rank
Defect category
Percentage of critical/major
deficiencies with this
defect category
1
Investigation of anomalies
6.5%
2
Quality management
5.5%
3
Investigation of anomalies – CAPA
4.7%
=4
Contamination, chemical/physical (or potential for)
3.7%
=4
Supplier and contractor audit
3.7%
6
Quality management – change control
3.6%
=7
Documentation – procedures/PSF/TAs
2.7%
=7
Personnel issues – training
2.7%
=9
Design and maintenance of equipment
2.6%
=9
Documentation – manufacturing
2.6%
=9
Finished product testing – chemical
2.6%
development of a potential alternative:
thermostable adenylate kinase (tAK)
indicators, isolated from thermophilic
bacteria Sulpholobus acidocaldariusas in
volcanic springs, which can be used as a
rapid read-out surrogate marker for
assessing decontamination process
efficacy. He provided a comparison of tAK
indicator and BI performance in lab
studies of two commercial (H2O2)
decontamination systems. When
monitoring H2O2 decontamination, the
tAK monitoring test could give reduced
turnaround time for the decontamination
process development and optimisation,
and could potentially improve surety
around process performance, he said.
Guest speaker Professor Val Edward
Jones, Clinical Director, MelBec
Microbiology and microbiology star of UK
TV series Embarrassing Bodies, gave a
wide-ranging view of microbial hygiene
issues outside of the cleanroom. The TV
series, aimed largely at teenagers and
young adults, reveals the often shocking
medical conditions of people who have
been unable to get help from regular
doctors and, thus, appear on the show on
the basis that they will get the specialist
help they need.
The show also filmed various hygiene
awareness-raising projects covering a
range of aspects from body odour and bad
breath to the hygiene of mobile phones,
handbags, make-up, toilets, playgrounds,
childrens’ toys and, the lack of handwashing in airports.
Rarely cleaned, many everyday objects
such as mobiles phones carry a multitude
of undesirable organisms: touchscreen
phones can carry upwards of 100,000
bacterial cells on the screen, she said.
Handbags, keyboards, toys and
playground furniture were also found to
have populations of undesirable microbes.
While for most people this poses a small
risk, as we lose our first-line
antimicrobials, the risk for those in
hospitals is much more severe. Unless new
antibiotics or new antimicrobial strategies
can be found we are looking at a future
where invasive surgery would no longer be
possible, she said.
With the cost of bringing new
antibiotics to market estimated at
US$500m–$1bn (£300–£550m), many
drugmakers are withdrawing from this
area of research in favour of more
profitable lifestyle drugs. Since 2009, only
a handful of antibiotics have been
developed or approved.
While alternative antimicrobial
strategies are under investigation
‘prevention is better than cure’, she said.
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