Pharmaceutical Preparations Newsletter 9

Pharmaceutical
Preparations
Industrial Weighing & Product Inspection
Precise Weighing
of Highly Potent Pharmaceutical Compounds
Weighing platforms from METTLER TOLEDO ensure precision weighing
of highly potent pharmaceutical compounds for Telstar ACE, a world
leading manufacturer of specialist high containment barrier and isolator
systems for the pharmaceutical industry.
Telstar ACE needed highly accurate scales
for weights varying from 10 grams up to
10 kg in an ATEX Zone 1 environment.
The solution from METTLER TOLEDO
was two weighing platforms: a WM503xCL
platform for the small weights and a
KA15sx for the larger weights. Both platforms are connected to one IND690
weighing terminal. The weighing terminal is then connected to the clients system
through an RS232 interface. The scales
in this system are intrinsically safe and
ingress protected to IP66, allowing high
pressure spray washing.
They are then connected via barriers to the
indicator in the safe area. According to Telstar ACE’s Project Engineer Neal Horobin,
“We selected METTLER TOLEDO because
of its reputation as the leading supplier of
weighing technology. The equipment has
worked exactly as required, meeting the
very precise weighing accuracies expected
by our client.” He added, “I must say that I
found METTLER TOLEDO to be very helpful throughout the whole process, from
the selection of the right weighing equipment right through to final commissioning on site.”
9
News
High Precision
High Precision Weighing for Isolators
METTLER TOLEDO’s new stainless steel
WM-Ex platforms are designed for measuring small weights, in this case up to
500g with a readability of 0.001g, in haz-
ardous environments (ATEX Zone 1, FM
Class 1, Div. 1). The WM-Ex range was specifically developed to meet the growing
market trend towards decreasing sample
sizes coupled with increasing quality and
precision requirements, particularly in
hazardous environments such as pharmaceutical manufacturing facilities.
The picture above shows the inside of an isolator with the KA15sx located in the foreground and the WM593x located in the background
Publisher
Mettler-Toledo AG
Industrial
Heuwinkelstrasse
CH-8606 Nänikon
Switzerland
Production
MarCom Industrial
CH-8606 Nänikon
Switzerland
Subject to technical changes
© 01/2010 Mettler-Toledo AG
Printed in Switzerland
2
­METTLER ­TOLEDO
Pharmaceutical Preparations News 9
KA15sx
Maximum capacity 15.0 kg
Approved readability 0.1g
WM593X
Maximum capacity 510 g
Approved readability 0.001g
The KA15sx, also stainless steel, is designed for measuring larger quantities,
up to 15kg, with a readability of 0.1g
and is also approved for use in hazardous environments (ATEX Zone 1/21, FM
Class 1, Div. 1). The IND690 weighing
terminal can be used with up to four
weighing platforms simultaneously. Designed for hygienic sensitive areas, including GMP areas, it is water and dust
tight to IP69, allowing high pressure
cleaning. Easy to use, its large high luminance VFD dot matrix display shows
weight or other data with characters up
to 35mm high.
IND690
Up to 4 platforms (IDNet, SICS, analog)
can be connected. Suitable for all
industrial environments thanks to IP69k
protection. Fully expandable with
8 application specific software pacs.
For more information Log onto:
www.mt.com/IND690
www.mt.com/k-line
www.mt.com/weigh-modules
The picture above shows the outside of the isolator with the IND690 weighing terminal in its panel format.
About Telstar ACE
Telstar ACE, formerly known as Applied
Containment Engineering, was purchased
in 2007 by Telstar, an international business group operating in sectors as varied
as industry, scientific research and development, and life and health sciences.
Based in Dewsbury, West Yorkshire, UK,
Telstar ACE specializes in the design and
supply of sophisticated high containment
barrier and isolator systems almost exclusively for the pharmaceutical industry.
The company has a worldwide client base
including names such as Astra Zeneca,
GlaxoSmithKline and Pfizer.
www.telstar-lifesciences.com
­METTLER ­TOLEDO
Pharmaceutical Preparations News 9
3
®
Formulation
FormWeigh.Net
A
UnSizeable
objectif Objective:
de taille :
Ensuring
BetterlaFormulation
Traceability
mieux assurer
tracabilité de
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The
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the secteurs
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aussireason
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tations
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et en 2007 les consultations officielles ont commencé.
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anune
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», ajoute Monsieur
Mr.
Hyfte,
IT Manager
at Pharmatis.
Van Van
Hyfte,
Responsable
Informatique
de
In
place since
new2008,
softPharmatis.
EnMarch
place 2008,
depuisthe
mars
ware
package
has provided
usersatissatle nouveau
progiciel
donne100%
entière
isfaction.
All utilisateurs.
the raw materials,
faction aux
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les maand
ingredients,
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principes
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label
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the
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codeThe
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and
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et identifie
ses
aid
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matières
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à l’aide d’un lecteur
codes-barres.
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of
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1500kg
et d’une
balancebalance.
de laboratoire.
4
6
­METTLER
M
ETTLER ­TTOLEDO
OLEDO
Préparations pharmaceutiques
News9 8
Pharmaceutical
Preparations News
included
current
batch.
Thanks
à la peséeinde the
chaque
matière
intervenant
to
interface
between enthe
Pharmadansthele lot
de la fabrication
cours.
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tis
CAPM system,
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all the
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entrewhich
le système
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data
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it is et
postionsFormWeigh.Net
de la base matières
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le
sible
to FormWeigh.Net,
display information
on the safety
logiciel
un affichage
autoof
the weighed
product
automatically,des
in
matique,
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de pictogramme,
the
form of a pictogram.
Theduoperator
informations
sur la sécurité
produit conpesé
tinues
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est possible.
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peséewhich
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à un barrethe
graphe
qui luitolerance
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zone
“We
have achieved
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« Nous avonsgreater
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dérablement gagné
en sécurité
pharma®
since
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ceutique
et en productivité
depuis la mise
software”,
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en place dudeclares
logicielMr.
FormWeigh.Net»,
déwho
the site’s
Production
Department
clare isMonsieur
Piha,
pharmacien,
respon-
® formulation
Logiciel de formulation
FormWeigh.Net
FormWeigh.Net
software ® avec affichage
des données
sécurité
dessafety
matières
premières.
with
display ofderaw
material
data.
9000-liter tank
mounted
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de la qualité.
Garvenspondérale
checkweigher
with remote
display déporté
Trieuse
Garvens
avec affichage
Trieuse pondérale Garvens avec affichage déporté
sable du service Production du site. « Les
Manager.
“We no
longer need
to weigh
sable
du service
Production
du site.
« Les
doubles pesées et les saisies manuelles sur
things twice
and
manual
entriessur
on
doubles
pesées
et make
les saisies
manuelles
l’indicateur de pesage ne sont plus nécesthe weighingdeindicator”.
acl’indicateur
pesage neMoreover,
sont plus all
nécessaires. » De plus, tous les accès sont gérés
cess is »managed
by user
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sont gérés
par des mots de passe utilisateurs qui gaguarantee
thedetraceability
of data.qui gapar
des mots
passe utilisateurs
rantissent la traçabilité des informations.
rantissent la traçabilité des informations.
Weighing: Present at Every Stage
Le pesage : présent à toutes
of the
Production
Process
Le
pesage
: présent
à toutes
les étapes de la fabrication
In addition
terminals, balles
étapes todeweighing
la fabrication
Outre les boxs de pesée, les balances sont
ances are
also found
all over
the PharmaOutre
les boxs
de pesée,
les balances
sont
présentent sur l’ensemble du site Pharmatis site. After
reconciliation
the
présentent
surthe
l’ensemble
du sitestage,
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materials
usually
enter production
in
tis.
l’étape
de réconciliation,
les matières premières passent en fabrication le
mixerspremières
equippedpassent
with weighing
sensors.
tières
en fabrication
le
plus souvent dans des mélangeurs équipés
Thesesouvent
reaction
vessels
then supply équipés
several
plus
dans
des mélangeurs
de capteurs de poids. Ces réacteurs alimenpackaging
bothCes
forréacteurs
liquid and
semide
capteurslines,
de poids.
alimen-
tent ensuite plusieurs lignes de conditionnesolidensuite
pharmaceutical
forms.
In order to
tent
plusieurs lignes
de conditionnement aussi bien pour les formes galéniques
optimize
and comply
withgaléniques
the regument
aussifilling
bien pour
les formes
liquides ou pâteuses. Afin d’optimiser le
lations, statistical
checks
then made
liquides
ou pâteuses.
Afinare
d’optimiser
le
remplissage et d’être en conformité avec la
using METTLER
TOLEDO
SQC balances
remplissage
et d’être
en conformité
avec la
réglementation, des contrôles statistiques
connected to the
software.
réglementation,
des FreeWeigh
contrôles statistiques
sont ensuite opérés à l’aide de balances
Garvens
checkweighers
can be
for
sont
ensuite
opérés à l’aide
de used,
balances
SQC METTLER TOLEDO connectées au loexample,
to check
the average
weightauand
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METTLER
TOLEDO
connectées
logiciel FreeWeigh. Des trieuses pondérales
for missing
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in drug
packs.
giciel
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Beingle very
satisfied
METTLER
trôler
poids moyen
et leswith
manquants
dans
les étuis de médicaments.
TOLEDO’s
equipment, Pharmatis enles
étuis de médicaments.
Très satisfait des équipements METTLLER
trusted
all the
of its
balances
Très
satisfait
desservicing
équipements
METTLLER
TOLEDO, Pharmatis a confié l’ensemble
and its legal
metrology
monitoring
to
TOLEDO,
Pharmatis
a confié
l’ensemble
de l’entretien de son parc de balances et
METTLER
TOLEDO.
planned
new verde
l’entretien
de son Aparc
de balances
et
le suivi en métrologie légale à METTLER
sion
of the
softle
suivi
en statistical
métrologiequality
légale àcontrol
METTLER
TOLEDO. Un projet de nouvelle version de
ware is even
new chalTOLEDO.
Un being
projet discussed.
de nouvelleA version
de
logiciel de contrôle statistique de la qualité
lenge fordeMETTLER
TOLEDO…
logiciel
contrôle statistique
de la qualité
est même en cours de réflexion. Un nouest même en cours de réflexion. Un nouveau challenge pour METTLER TOLEDO…
veau challenge pour METTLER TOLEDO…
Issu à l’origine, d’une équipe pluridisciplinaire
Issu
à l’origine,
d’une équipe
pluridisciplinaire
Initially
comprising
a multidisciplinary
du groupe Boehringer Ingelheim, le laboradu groupe
Ingelheim,
le laborateam
from Boehringer
the Boehringer
Ingelheim
group,
toire pharmaceutique Pharmatis est fondé
toirePharmatis
pharmaceutique
Pharmatis laboratory
est fondé
the
pharmaceutical
en 2001. Spécialisé dans le façonnage des
en 2001.
Spécialisé
dansSpecializing
le façonnage
was
founded
in 2001.
in des
the
liquides
de sachets
et sticks
et des pâteux,
liquides de sachets
et in
sticks
et des
pâteux,
manufacture
of
liquids
sachets
and
sticks
Pharmatis est aujourd’hui le leader euroPharmatis est aujourd’hui le leader euroand
Pharmatis
is now the
péen semi-solids,
sur les gels buvables
conditionnés
en
péen sur les gels buvables conditionnés en
European
in drinkable
gels
packaged
sachets etleader
en sticks
et compte
environ
150
sachets et en sticks et compte environ 150
in
sachetsPharmatis
and sticksréalise
and has
workforce
salariés.
plusa de
la moisalariés. Pharmatis réalise plus de la moitié around
de son chiffres
d’affaires More
à l’export
of
150 employees.
than pour
half
tié de son chiffres d’affaires à l’export pour
le compte
de grands
groupes
pharmaceuof
Pharmatis’
export
sales
are
to
major
le compte de grands groupes pharmaceutiques, de laboratoires
et de lapharmaceutical
groups,génériques
generic laboratories
tiques, de laboratoires
génériques
et de laboratoires
vétérinaires.
and
veterinary
laboratories.
boratoires
vétérinaires.
Outre la fabrication, Pharmatis est capable
Apart from
manufacturing,
Pharmatis
is able
Outre
la fabrication,
Pharmatis
est capable
de fournir un service complet à ses clients
to provide
complete
to its
customers
de
fournir aun
serviceservice
complet
à ses
clients
depuis l’analyse des matières premières
depuis
l’analyse
desmaterials
matièresto release
premières
from analysis
of raw
of
jusqu’à la libération des lots. Pharmatis réajusqu’à
libération des
Pharmatis
réabatches.laPharmatis
alsolots.
develops
formulas,
lise également le développement de formules,
lise également
le développement
de draws
formules,
validates
analytical
methods
up
les validations
analytiques
et laand
rédaction
de
les validations analytiques
et la rédaction
de
pharmaceutical
dossiers
(CTDs).
For
some
dossiers pharmaceutiques (CTD). L’entreprise
dossiers
pharmaceutiques
(CTD).
L’entreprise
years
now,
the
company
has
even
had
a
fleet
s’est même dotée, depuis quelques années,
s’est même dotée, depuis quelques années,
of
vehicles
for véhicules
transporting
pharmaceutical
d’une
flotte de
permettant
le transd’une flotte de véhicules permettant le transproducts
at controlled
temperature.sous temport des produits
pharmaceutiques
port des produits pharmaceutiques sous température dirigée.
pérature dirigée.
Located at Estrées Saint Denis in the Oise
Située
à Estrées
Saint Denis
dansPharmatis,
l’Oise sur
department
on a 35,000
m 2 site,
Située
à Estrées
Saint Denis
dans l’Oise sur
2, Pharmatis, déjà
un
terrain
de
35000m
already
certified
ISO
9001,
is
one
of
the déjà
first
2
un terrain de 35000m , Pharmatis,
certifié
ISO9001, est
l’unindes
premiers
sites
pharmaceutical
sites
France
to
have
certifié ISO9001, est l’un des premiers sites
pharmaceutiques
français
a avoir
obtenu la
been granted the ISO
14001
environmental
pharmaceutiques
français
a avoir
obtenu la
certification ISO14001 pour l’environnement.
certification.ISO14001
The production
site, which
certification
pour l’environnement.
Le site de production, soumis aux Bonnes
Le
site dewith
production,
soumis auxPractice,
Bonnes
complies
Good Manufacturing
Pratiques de Fabrication, est capable de
Pratiques
de Fabrication,
est capable
can produce
3 million single
doses de
a
sortir jusqu’à 3 millions de doses unitaires
sortir
de doses
unitaires
day, jusqu’à
resulting3 millions
in annual
production
of
par jour soit une production annuelle d’envipar
jour soit une6000
production
approximately
tons ofannuelle
product. d’environ
6000 tonnes de produits.
ron 6000 tonnes de produits.
Monsieur Piha, pharmacien,
Monsieur
Piha, pharmacien,
Mr. Piha, pharmacist,
responsable
de la Production et
responsable de la Production et
Production
Manager
Monsieur Van
Hyfte, and
Monsieur Van Hyfte,
Mr.
Van
Hyfte,
Responsable Informatique
Responsable Informatique
IT Manager
METTLER TOLEDO Préparations pharmaceutiques
METTLER
TOLEDO
Préparations
pharmaceutiques
­METTLER ­
TOLEDO
Pharmaceutical
Preparations
News 8
News 8
9
7
5
7
Metal Detection
Tablex-PRO Provides New Cure
for Pharmaceutical Metal Detection Headaches
METTLER TOLEDO Safeline has announced the release of a new generation
of its well established Tablex metal detection systems. Tablex-PRO utilises
a new version of Safeline’s advanced Profile software which is tailored to
meet the specific requirements of the pharmaceutical industry.
Developed with today’s highly regulated
pharmaceutical production plants firmly
in mind and with an emphasis on current and future compliance requirements,
Tablex-PRO delivers the opportunity for
manufacturers to increase productivity,
reduce overall manufacturing costs and
improve their competitiveness. The new
systems will take metal detection for the
On-screen detector access log information
pharmaceutical and neutraceutical industries to an even higher level of sophistication providing manufacturers with real
benefits to address the challenges of an
increasingly demanding market.
Meeting and Exceeding
Compliance Needs
Among the features in the new software
package is a dual level, electronic signature log-in system which requires operators to enter a user name and password
for access. This advanced system captures
6
­METTLER ­TOLEDO
Pharmaceutical Preparations News 9
Tablex-PRO
pharmaceutical
metal detection
system
and stores all access activities in the form
of an access log. The log can be displayed
and viewed on the full colour touch screen
along with other important manufacturing data providing full compliance with
the requirements of 21 CFR part 11.
Inspection process traceability is supported through the inclusion of important
barcode and manufacturing batch code
information within the data collection
and storage system. This key data can be
displayed on the operator interface during
the manufacturing process.
Enhanced quality assurance is provided
through a dedicated password protected
QA system access level. Tablex-PRO systems advise when test routines need to be
performed and when testing is overdue via
highly visible screen messages. Built-in
performance validation software provides
intuitive, step-by-step guidance for quality
assurance testing.
Operational Efficiency –
the Key to Success
Maximising process efficiency and minimising downtime are critical as manufacturers strive for operational excellence.
The issue of maximising uptime is addressed through the use of a revolution-
ary Condition Monitoring feature which
constantly assesses the performance and
operation of key detector elements. This
system gives advanced warning of changes
which could potentially cause downtime if
left unaddressed. Messages from the Condition Monitoring system are displayed
on the high visibility touch screen user
interface. The early warning of potential
problems before they escalate to stop the
production process enables maintenance
routines to be conducted when equipment
is off-line to maximise uptime and production capacity.
System faults and warning messages are
also signalled via a high level, highly
visible, tri-colour status warning lamp
mounted on the machine. The lamp displays a green, amber or red status to indicate Condition Monitoring messages and
gives warnings of performance verification test requirements.
Informed to Make Decisions
Critical messages from Tablex-PRO detectors can be communicated directly to key
individuals within the manufacturers’
organisation via a unique GSM gateway
communication system. This allows the
detector to send instant SMS text messages
and emails to the mobile telephones or
SMS messages
sent direct to your
mobile telephone
in-boxes of those that need to know. Typically, maintenance engineers can receive
early warnings regarding potential downtime or line stoppages via the Condition
Monitoring feature whilst QA or Production Managers can be advised of over-due
validation testing of the system which
could lead to non-compliance issues if
not addressed.
Detecting Challenging Contaminants
Sensitivity enhancements have been
achieved through the development of a
multi-channel inspection technique combined with the use of ultra high frequency
technology. These techniques will set new
standards of performance within the industry, particularly with respect to the
detection of stainless steel contaminants
and irregular shaped contaminants such
as broken sieve wires.
Effective Contaminant Rejection
Tablex-PRO retains the benefits offered on
existing Tablex systems of a choice of two
interchangeable and failsafe reject devices
suitable for all product types and applications. The side diverter system is particularly effective where inlet and outlet
heights are low or restricted as the compact design minimises overall throughput
length. The lift flap diverter system has
been specifically developed for manufacturers needing straight line product flow.
This can help to reduce potential damage
to larger, effervescent and delicate tablets.
Both systems offer simple ‘no-tool’ stripdown, easy cleaning and are fully compliant with 21 CFR parts 210 and 211.
www.mt.com/safeline-tablexPRO
www.mt.com/metaldetection
www.mt.com/pi-pharma
Tablex-PRO side-divert reject option
­METTLER ­TOLEDO
Pharmaceutical Preparations News 9
7
Pharmaceutical Serialisation Integration
Smart Pharmaceutical Solutions
Help in the Fight Against Counterfeiting
The XS2 MV checkweighing, marking and vision control system from METTLER TOLEDO
Garvens has been chosen as the standard solution by one of the top 3 global pharmaceutical manufacturers as part of their worldwide serialisation, anti-counterfeiting and
quality improvement programme. The XS2 MV is designated to be installed in different
production lines in over 20 countries worldwide processing over 750 products of varying package size and weight.
The pharmaceutical company had a very
clear vision of the solution and requirements. These were meticulously written
down in a 60 page “User Requirement
Specification” (URS) document, cataloguing the 160 minimum technical,
software and performance requirements
which needed to be fulfilled. The pharmaceutical company made it clear that
The XS2 MV is the
complete pharmaceutical
serialisation solution
8
­METTLER ­TOLEDO
Pharmaceutical Preparations News 9
there was no room for compromise on
these requirements. During the 5 day
Factory Acceptance Test (FAT) carried out
on each unit, not only all these requirements were thoroughly tested but also
0.02% false reject rates at a line speed of
350 ppm were achieved. Only after all tests
had been passed and fully documented
was approval given for delivery.
Why METTLER TOLEDO Garvens?
This very complex project was processed
by Wulf Pries and Frank Borrmann at
the Garvens production site in Giesen,
Germany. During a recent interview Mr.
Pries stated that, “there were three main
reasons why this company chose Garvens: the first was the trust which had
been built up between the two companies through many years of business; the
second was the very reliable worldwide
service and support essential for global
operations and the final reason was that
only Garvens was able to satisfy all requirement specifications and deliver the
very consistent and high quality product
needed for the applications.”
Integrating Laser Printing Systems
“A further area of great interest is always
the choice of printing and camera systems”
continued Mr. Borrmann. “The decision
for this pharmaceutical company was really quite simple. This company already
had experience with using printing systems from Domino and Wolke and vision
systems from Systec, Laetus and Cognex.
All these companies were already listed
as one of their trusted partners. The URS
specified 3 different marking and vision
configurations depending on country of
delivery, production line constraints and
application requirements. The integration
of these marking and vision systems were
Laser marking,
vision control,
checkweighing
and labelling
combination
system
Strong Strategic Partnership
One small but very interesting point
Mr. Pries mentioned at the end of interview was that he noticed that the relationship between the two companies had
changed. The pharmaceutical company
now regarded Garvens more as an important strategic partner and not just an
equipment supplier.
System Advantages and Benefits
The XS2 MV is the most compact complete
serialisation and checkweighing solution
at present on the market needing only
a minimum of floor space which allows a
seamless integration in almost all production lines with the absolute minimum of
production line re-engineering. There are
two major plus points which make the XS2
MV so innovative and interesting for multinational pharmaceutical companies:
• Flexibility
The XS2 MV has been designed to be a
standard solution which will satisfy the requirements for the majority of production
lines where global deployment is planned.
It also has enough flexibility to offer bespoke solutions where a standard solution
is not possible.
• Designed for Trusted Partners
The XS2 MV has been designed to function
with a multitude of world leading marking
and camera systems giving complete freedom to choose components from suppliers
already designated as “trusted partners”
which greatly simplifies the integration
into IT networks by using tried and tested
data communication protocols.
All components, which include world
leading ink jet printing or laser marking systems, high-resolution verification
cameras, mechanical transfer units,
weighing assembly, automatic labeller and 3 separate sorting devices, have
been finely tuned to work in perfect unison even at extremely high speeds up to
90 m/min.
Application Functionality
The high precision mechanical transfer
unit takes the carton directly from the cartoner and transfers it to the printer in the
optimal position for serialisation marking. The marking is verified for legibility and correctness using a very sensitive
optical camera system before transferring
the carton to the weighing section. Once
the correct weight has been verified the
carton is then transferred to the optional
labeller for additional marking. The XS2
MV can optionally detect if the box has
open flaps or is not correctly aligned to
protect the printer head and downstream
bundle packaging equipment. All cartons
where the marking or weight cannot be
100% verified as being “good” are reliably rejected into lockable catch bins.
Each component has its own catch bin
to effectively separate and sort rejected
items. Finally all “good” boxes are safely
transferred to the customer’s conveyor for
further processing.
Full Track & Trace Compliance
The XS2 MV is fully compliant with current pharmaceutical regulations and
guidelines for the many different Track &
Trace concepts at present in use. The open
software interface concept eases communication with all standard data protocols
and network systems with simple upgrade
procedures for future Track & Trace requirements where standards may change
or are evolving.
The XS2 MV Marking and Verification
system is a complete serialisation solution
giving Track & Trace capabilities to existing or new production lines with the highest degree of flexibility presently available
on the market.
www.mt.com/garvens
www.mt.com/garvens-serialisation
GARVENS
White Paper
no problem for Garvens as the XS2 MV was
designed to work with all possible combinations of all leading printing and vision
verification system components.”
Checkweighing
A Guide to Pharmaceutical Serialisation
Choosing the Right Equipment Supplier
­METTLER ­TOLEDO
Pharmaceutical Preparations News 9
9
Online Tools
Use www.mt.com as a
Work Efficiency Resource
Webinars – Learn More with Little Time and Effort
Join a wide array of webinars to learn about various topics
from choosing the right technology to process optimization.
We offer both Live Webinars where you can speak directly
with our specialists and recorded On Demand Webcasts
which are available at your convenience, 24 hours a day.
View the full range of webinars:
www.mt.com/webinars
Value Calculators – Find Out How to Save Money
Download our calculators and work out how much
you could be saving.
Colored weight control system saves both time and money:
www.mt.com/ind-colorweight-calculator
Save money with quality control and correct filling:
www.mt.com/sqc-calculator
Eliminate unnecessary costs during formulation
and maximize your profitability:
www.mt.com/formulation-calculator
Learn how to save over 100,000 €/year by reducing
only 0.5g per pack:
www.mt.com/garvens-savesmoney
10
­METTLER ­TOLEDO
Pharmaceutical Preparations News 9
Download Comprehensive Product Documentation
METTLER TOLEDO Safeline Profile Metal Detectors provide the ultimate
in metal detection performance. They help manufacturers increase productivity,
reduce overall manufacturing costs and improve competitiveness.
www.mt.com/safeline-profile
The largest selection of hazardous area weighing equipment on the
market has been combined into one easy to use catalogue combing
regulatory guidelines and comprehensive product information.
www.mt.com/ind-hazcat
Case Studies
Looking for solutions to a problem? No problem.
Read case studies of real problems and see how
METTLER TOLEDO found a solution.
www.mt.com/case_studies
Free Guides and White/Technical Papers
METTLER TOLEDO has published a range of authoritative
guides and white papers that cover focus areas which enable
you to select the right solutions to improve your processes.
From statistical quality control, installing equipment in an
explosive area and Good Weighing Practice™ these free guides
provide comprehensive information on how you can improve
your process, comply with hazardous legislation and ensure
you weigh to your regulations. Request your free copy here.
www.mt.com/sqc-guide
www.mt.com/GWP
www.mt.com/hazardous
Garvens
Checkweighing
Guide
Safeline
Metal Detection
Guide
Safeline
X-ray Inspection
Guide
GWP®
Good Weighing Practice™
These guides offer support in installing an all-encompassing
product inspection program and provide advice to help you
in achieving compliance with standards, regulations and
legislation. Request your free guides:
www.mt.com/pi-guides
Good Weighing Practice™
Guaranteed Quality
Minimized Risk
Reduced Costs
Secure Audits
Minimize Weighing Risk
by Adopting Good Weighing Practice™
SQC
Guide
Hazardous
area guide
Good Weighing
Practice™
­METTLER ­TOLEDO
Pharmaceutical Preparations News 9
11
IPac Delivers Optimised Performance
Qualification and validation protocols and documentation solutions that satisfy
the demand of the FDA and other regulatory bodies. ISO standards state:
"Equipment shall be verified at specific intervals, or prior to use. The basis
for verification shall be recorded. Records of the results of calibration and
verification shall be maintained."
At METTLER TOLEDO we appreciate the
importance of obtaining the optimum
performance of new equipment from day
one. Our comprehensive IPac qualification package ensures new machines are
providing a return on your investment
right from the start. Knowledgeable service professionals will confirm satisfactory
installation of new weighing systems and
commission your equipment to achieve
the highest level of performance. Getting
the best from your weighing system, providing peace of mind for you and guaranteed product quality for your customers.
Ongoing performance levels are assured
through hands-on operator familiarisation training.
With IPac you will:
• Achieve and maintain the qualified
state
• Reduce the chance of audit challenges
• Ensure proper results using
OEM protocols
• Lower the expense of in-house
solutions
ISO22000 & ISO9001 CI 7.6
Industrial Weighing: IPac Initial
Qualification Package (IQ, OQ, PQ)
IPac is designed to be consistent with the
requirements of GMP and other quality
systems. Execution of an IPac by a trained
METTLER TOLEDO service representative
delivers a self-contained solution for new
equipment qualification or for re-qualification of equipment that is re-purposed,
moved or lacks adequate documentation.
The IPac qualification package supports
your verification processes and includes:
• Confirmation of acceptable equipment
installation standards
• Initial commissioning, set up and
testing using your own products
• Generation of an initial performance
verification certificate
• A proposal and schedule for a
continuous performance verification
programme
For more information log onto:
www.mt.com/ipac
Mettler-Toledo AG
CH-8606 Greifensee
Switzerland
Tel. + 41 44 944 22 11
Fax + 41 44 944 30 60
www.mt.com/ind-pharma
Your M
­ ETTLER ­TOLEDO contact:
For more information