Magazine - Excellence United

Comments

Transcription

Magazine - Excellence United
Operational Excellence:
High Quality in Production
FUTURE
DEAR READER,
Focus on Quality
The debate about the quality of medicines is not new. In recent years,
however, since the Food and Drug Administration (FDA) launched
its “Pharmaceutical cGMPs for the 21st Century” initiative in 2002,
it has gained considerable momentum. In addition to the FDA, a
second international regulatory body, the European Medicines Agency
(EMA), has become active in this field – also in joint projects such
as a pilot program on Quality by Design. The International Society for
Pharmaceutical Engineering (ISPE) has launched two projects that
focus on the quality of pharmaceutical production with its initiatives
on the subjects of “Drug Shortages” and “Quality Metrics”. The
time line below lists selected milestones in this development and
demonstrates that quality is one of the key challenges of the future
for pharmaceutical production.
FDA-EMA Generic Drug
Application Inspections
Initiative
Joint initiative for the
assessment of biological
equivalence studies in the
approval of generic drugs
ISPE’s Drug Shortages
Initiative
Initiative to support
global efforts to prevent
drug shortages
FDA Office of New Drug
Quality Assessment (ONDQA)
Guidelines for the evaluation
of the critical quality attributes and manufacturing
processes of new medicines
2004
2005
2006
FDA Unapproved Drugs
Initiative
Initiative for drug safety
(prohibition of unapproved
medicines)
FDA Critical Path Initiative
Initiative to introduce
quality guidelines for
the development and
manufacture of medical
products
Quality remains one of the
most crucial topics for
the pharmaceutical industry.
That applies equally to both
products, and production
processes. This is demonstrated, among other things,
by the new EU GMP guidelines that came into force
on 1 March 2015 and
the GMP documents that
are currently still being revised. Issues such as the prevention of cross-contamination, process validation and the
continuous monitoring of global supply chains play major
roles here.
FDA Sentinel Initiative
Introduction of a monitoring
system for the safety of
medicines, biopharmaceuticals
and medical equipment
2008
FDA-EMA Pilot
Pilot program for the
parallel evaluation
of Quality by Design
(QbD) submissions
2009
2011
FDA Safe Use Initiative
Cooperation to reduce
avoidable damage by drugs
FDA Medical Countermeasures Initiative (MCMi)
Initiative for measures
against chemical, biological and infectious hazards
EMA Innovative
Medicines Initiative (IMI)
Partnership for the
more efficient research
and development
of drugs in Europe
2012
2013
FDA Global Initiative
Development of a
community for a global
public safety net
in the health sector
ISPE Quality Metrics
Initiative
Development of
uniform standards
for reports to the FDA
2014
FDA Voluntary Compliance
Improvement Program
(VCIP) Pilot
Voluntary self-assessment
and correction for
companies with quality
assurance problems
New EMA GMP Guidelines
Expanded EU GMP
guidelines with focus on
quality risk management
and contamination
control (toxicological
evaluation, prevention of
cross-contamination)
2015
2016
FDA Increase Quality
Oversight
Increased demand for
in-company quality control;
more inspections at
pharmaceutical companies
outside the USA
FDA Case for Quality
Project to improve
the quality of medical
equipment
We aspire not only to help you do your job by providing
the best technology, but also to support you with our
expertise. That is why, in the last four years since the
foundation of Excellence United, we have developed joint
offerings that are available to you worldwide. We bring
together state-of-the-art technological solutions for your
entire value chain – from development to production and
packaging to service.
The name of our magazine “we connect” puts this aspiration
in a nutshell. We connect people, technology and processes. Working with you, we develop the best possible
solutions to meet your needs.
On behalf of Excellence United I would like to cordially
invite you to find out about our products and services in
this magazine.
Yours sincerely,
Markus Ströbel
Spokesman of Excellence United
CONTENTS
2 | we connect
2
3
4
6
7
8
9
Focus on Quality
Editorial
Towards a New Culture of Quality
International Experts Exchange Experience
Pareto Principle in the Machine Room
Interview with Birgit Fischer of the Association of Research-Based Pharmaceutical Companies (VFA)
Working Together for Growth
10 New “Small” Models from B+S Bausch+Ströbel
12 Three Machines for Maximum Tableting
Productivity Fette Compacting
14 Realizing Enormous Potentials Glatt
16 Technology Made to Measure Harro Höfliger
18 Packaging Tablets Efficiently and Flexibly Uhlmann
Imprint
© Excellence United Marketing GmbH, 2015. All rights reserved.
The rights to all texts, images and graphics lie with
Excellence United Marketing GmbH and the respective partner companies.
Picture Credits
Cover: © GettyImages-485206417 – Monty Rakusen; page 5: © .shock –
Fotolia.com; page 8: © Birgit Fischer, Association of Research-Based Pharmaceutical
Companies (VFA); page 9: © pressmaster – Fotolia.com; pages 10–11:
© Bausch+Ströbel; pages 12–13: © Fette Compacting; pages 14–15: © Glatt;
pages 16–17: © Harro Höfliger; pages 18–19: © Uhlmann
we connect | 3 PHARMAPRODUCTION
Towards a
New Culture
of Quality
Pharmaceutical companies have recently experienced
problems in their production processes, leading to
bottlenecks and shortages. Another result has been intense
scrutiny of industry procedures that for years were considered tried and true. Government authorities in the US
and Europe have now taken the initiative and are working
with manufacturers to establish a new culture of quality
in the pharmaceutical industry.
It’s an eye-catching statistic: between 2010 and 2013,
the number of warning letters issued by the US Food
and Drug Administration (FDA) for noncompliance with
pharmaceutical industry regulations increased tenfold.
Consequently, by April 2013 there were significant shortages of some 300 drugs in the US alone, with the cost
of compensating for the shortfalls estimated at 400 million
dollars. According to the European Medicines Agency
(EMA), disruptions in the production of critical medicines in
Europe have also increased dramatically in recent years.
A study published in June 2013 by the International Society
for Pharmaceutical Engineering (ISPE) shows that the problem often stems from quality assurance difficulties during
production, a phenomenon that has caught the attention of
ALARMING INCREASE IN FDA WARNING LETTERS
In 2014 the number
of letters issued by the
US Food and Drug
Administration (FDA) was
almost 20 times greater
than in 2009. The government agency sends out
the warnings when
production procedures
or facilities do not meet
the relevant good
manufacturing practice
(GMP) standards.
9,000
8,690
7,000
6,760
6,000
5,000
4,882
4,000
3,000
1,720
2,000
1,000
673
474
0
2009
2010
2011
Quelle: Food and Drug Administration – http://www.fda.gov/downloads/ICECI/EnforcementActions/UCM443198.pdf
4 | we connect
2012
2013
2014
government authorities. At the end of 2012, the EMA
therefore launched an initiative to reduce the number of
cases where compliance with good manufacturing
practices (GMPs) is not met. Similarly, the FDA initiative
Pharmaceutical cGMPs for the 21st Century, begun in
2002, has moved into its next phase with the creation of
a new “super agency”, the Office of Pharmaceutical
Quality. The OPQ will pool regulatory expertise on qualityrelated issues in pharmaceutical production processes.
It will also cooperate with other agencies and with drug
makers to further develop the international framework
in this area.
Increase production requirements
A number of factors are forcing pharmaceutical manufacturers to change their production processes, such as cost
pressures resulting from new competitors based in emerging
countries, patents on blockbuster drugs that are now
expiring and the globalization of production networks.
Innovations in pharmaceutical research are also having an
impact on production – in the form of “personalized
medicine”, for example. In the future, drug-based therapy
will not only depend on the standard diagnosis for an
illness, but also on a patient’s individual characteristics
such as genetic factors. Pharmaceutical companies
will therefore need to have a range of individual, precisely
formulated medicines available. At the same time, the
growing use of highly potent active ingredients will require
that production systems meet even more stringent
safety standards. All of this means that drug makers will
need production processes and machines that are highly
efficient and reliable. Manufacturers of pharmaceutical
production machines therefore have a key role to play in
improving quality.
Excellence United – Production at a high level
Numerous elements must come together seamlessly
if production processes are to be efficient: processing
equipment and facilities must run smoothly, maintenance
and other services must be available as needed, and
operating personnel must be properly trained. Above all,
there can be no disruptions where processes overlap,
and quality levels at all points in the production chain must
meet current – and coming – requirements. Excellence
United therefore provides state-of-the-art production technology for the entire value chain, from product development to packaging. It also offers a comprehensive service
portfolio, including consulting and training. Here, too,
quality plays a key role. The alliance members pool their
expertise in workgroups in order to develop uniform standards and processes. That allows them to help customers
upgrade existing production processes and create
new facilities that meet tomorrow’s standards today.
we connect | 5 MAINTENANCE MANAGEMENT
Pareto Principle in the Machine Room
SALES
International Experts
Exchange Experience
The production of drugs and medical
products makes the greatest demands on
quality. The more people worldwide have
access to basic health care, the more
important a flawless supply chain becomes.
It is for good reason that the pharma
industry is one of the most strongly regulated sectors in the world, because only
if patient safety is guaranteed can the
entire industry continue on its successful
growth course.
The knowledge and experience of employees
at all levels play a decisive role here. In
recent decades, as Excellence United,
we have accumulated a unique wealth of
specialist knowledge. Our planners,
pharmacists and project managers work
in close cooperation with their contacts
on the user side. In the process, they gain
unique insights into the subjects that really
matter in practical everyday working along
the entire pharmaceutical value chain –
beginning in the laboratory and progressing
all the way to the packaged product on
the pallet.
Within Excellence United we pool this
knowledge. And with our specialist symposia we have created a platform that enables
experts to exchange ideas and experiences
of the latest challenges and future trends
in pharmaceutical production. The focus
is on clearly defined topics relating to the
laboratory and production. As a result,
participants can increase their knowledge
in selected areas and benefit from international best practices. In addition to the
experts from Excellence United, specialists
from the field, from universities, organizations and industrial associations share their
knowledge at these symposia. Thematically, the symposia cover the entire range
of pharmaceutical production. Which
subjects are dealt with in a specific country
is determined by the concrete needs of
the users in that country.
You can find up-to-date information about
planned symposia on the Excellence United
website. We would also be very pleased
to receive your suggestions for topics by
email at: [email protected]
Quelle: Glatt GmbH
20 % of the input produces 80 % of the result. This formula
is also known as the 80 – 20 rule or the Pareto Principle.
It provides insight into economic relationships and indicates where you can find optimization potential. For pharmaceutical producers, for example, this effect is especially
vident when it comes to maintenance. Here, according to
the Pareto Principle, 20 % of the critical parts in a machine
cause 80 % of the breakdown costs. If manufacturers
optimize these 20 % in a targeted way, the whole machine
will run dramatically better. The key to this increase in
efficiency is the FMECA, a new analysis service offered by
Excellence United.
Excellence United recently invited customers to Frankfurt
am Main for its second Experience Days workshop. Under
the heading “Maintenance Management 2020”, a group
of specialists sat down with customers and examined
requirements and future trends in production. The discussion focused on new opportunities for planning and
optimization. It emerged that the Failure Mode, Effects and
Criticality Analysis (FMECA) method is a highly efficient
means of optimizing machines. FMECA is a formal method
for prioritizing equipment on the basis of economic targets.
6 | we connect
This involves identifying the critical parts that have the
greatest impact on machine operation. The analysis makes
it clear which components have the highest failure rates and
can cause the greatest economic damage. The method uses
this information to identify ways of reducing critical factors.
The results increase production availability and provide
valuable information for optimizing spare-part management
and developing the best possible maintenance strategy.
Are you interested in an FMECA analysis? The after-sales
service of the Excellence United partners would be happy
to support you in this area. The strategic alliance has
pledged to use a pragmatic and standardized approach on
behalf of its customers.
Would you also like to attend the next Excellence United
Experience Days?
Then contact us at: [email protected]
we connect | 7 QUALITY
QUALITY
“There can be no compromises on the
quality of medicines”
Where is the pharmaceutical industry heading? Five questions to
Birgit Fischer, Chief Executive of the Association of Research-Based
Pharmaceutical Companies (VFA).
In your opinion, what role will research play in coming years?
Birgit Fischer: Research and development are at the center of the
work of research-based pharmaceutical companies. Today, however,
the development of a new drug already costs an average of
between 1.0 and 1.6 billion dollars and is threatening to become
even more expensive in the future. That’s why it is an important
industry goal to increase success rates while keeping R&D expenditure stable. More and more often today firms work together in
research groups or with academic researchers. Open access to
industrial research findings and research resources is no longer
an alien concept.
Which overall trends are discernible?
Research-based pharmaceutical companies are prioritizing the
areas where the need is greatest: for example, serious and lifethreatening diseases. Accordingly, one third of all projects aim to
improve cancer therapy and 20 % of projects focus on the treatment
of inflammatory diseases, such as MS and rheumatism. Another
important advance is personalized medicine, in which there is direct
interaction between diagnostics and drugs. In this therapeutic
approach the most suitable medicine is chosen on the basis of the
results of genetic and other tests.
Which products are now set to enter the market?
In the next few years we anticipate additional improvements in
therapy – for example, for people with hepatitis C, pulmonary
diseases and coagulation disorders. In many of these cases, too,
Germany is likely to benefit as the production location.
In which countries do you expect to see the highest growth rates over
the next few years?
Until a few years ago, the industrialized countries were by far the
most important sales markets for medicinal drugs. Today this
position is shared with the emerging economies of China, India,
Latin America and Eastern Europe. What does that mean for
the pharma industry? Now that production has already become
strongly globalized, R&D and sales will increasingly also use
the new growth markets. But, of course, the industry will not give
up its activities in developed markets.
How important, in your view, is quality in production?
There can be no compromises on the technical quality of medicines.
And because that is the case, production plants in Germany can
be competitive in the globalized world economy: they verifiably
create the required quality assurance for highly complex products
(for example, biopharmaceuticals and vaccines as well as for
challenging synthetic chemical medicines). The key to this is
intelligently controlled, highly automated machines combined with
well-trained and highly motivated personnel.
MAIN AREAS OF PHARMA INDUSTRY RESEARCH
The member companies of the
Association of Research-Based
Pharmaceutical Companies (VFA)
could put medicines for more
than 110 diseases on the market
by 2017. Almost one third of
all projects are focusing on
improving cancer treatments,
a complex field that benefits
strongly from flexible medication. Specialized quality and
flexibility in pharmaceutical
production will become even
more important in these areas.
projects on pain
projects on
eye diseases
projects on mental illness
projects on
neurodegenerative diseases
projects on
other diseases of the
nervous system
projects on
cardiovascular diseases
projects on
urological diseases
projects on chronic
obstructive pulmonary
disease
projects on infectious
diseases
projects on type
2 diabetes
projects on cancer disorders
Status in May 2013
Source: VFA
Four years after its foundation, Excellence United can look
back on a positive interim result: the small and mediumsized privately owned engineering companies that make up
the alliance have successfully continued to grow. The
alliance’s total turnover increased from around € 965 million
in 2013 to roughly € 1.055 billion in the last business
year. Since its foundation, the number of people working
for alliance companies worldwide has risen from 4,800 to
over 6,000, including more than 600 service employees.
As a result, the Excellence United partnership is by far the
largest supplier of pharma industry solutions in the world.
Foundation of Excellence United Marketing GmbH
In 2014, the alliance was able to realize another milestone
in its strategy with the foundation of Excellence United
Marketing GmbH. In addition to overarching marketing
activities, the new company is currently coordinating eight
project workgroups. Among others, key areas here are
technical cooperation, service, sales and integrated quality
management.
MINIMIZING INTERFACE
PROBLEMS – PRODUCTION
LINE PROJECTS FROM A
SINGLE SOURCE
Should the new production line guarantee efficient processes
from the very start? Of course. That’s why integrated project
management is so important.
The key to success in production line projects with different
equipment manufacturers is coordination between the companies
involved. Cost, quality and date targets can only be met if all
the participants work hand in hand. Unified project management
enables Excellence United to reduce typical interface problems and
offer customers the reliable completion of ambitious production
line projects. Among other things, the business offering includes:
• Integrated project management with established processes and
communication within the alliance based on an industry-specific
pool of knowledge.
• Best-in-class equipment and service as well as outstanding
problem-solving expertise.
projects on inflammatory
diseases
projects on blood disorders
8 | we connect
Excellence United aims to provide best-in-class engineering for the entire value chain in pharmaceutical production.
Although it is a highly ambitious goal, this focus on
quality is clearly paying off. Excellence United partners
currently have more than 40,000 of their plants in use
around the world and their growth prospects are good.
• Transparency and cost certainty because Excellence United partners
work together without any mark-up. Furthermore, the guarantee
for all components of the complete installation only begins when the
entire production line is in place at the customer’s plant.
• Compatibility of all sub-systems and machines.
• Coordinated after-sales packages for hotline/support, spare parts,
maintenance, training, updates, upgrades and a joint Service Portal.
Contact: [email protected]
projects on other metabolic
disorders
projects on
diseases that affect women
projectws on
osteoporosis
Working Together
for Growth
projects on other medical fields
Excellence United milestones: Highlights
from the last four years show how
fast the alliance has developed. The
partner companies have expanded
their German sites and developed their
presence in international markets.
2011
Five specialist engineering companies
working in the field of pharmaceutical
production come together in a strategic
alliance to form EXCELLENCE UNITED. Ever
since the network has offered its customers
technologically advanced production
solutions of the highest quality and comprehensive service around the globe.
2014
The foundation of
Excellence United
Marketing GmbH enables
the alliance to offer its
customers a COMPREHENSIVE SERVICE from
a single source in the
future.
we connect | 9 PARTNERS
New “Small” Models from B+S
INNOVATIONS
Virtual Reality
can be used for the entire
duration of a project: from
planning to the training of
operators. A virtual mock-up
can be seen at ACHEMA.
The Bausch+Ströbel range has always included semiautomatic machines for small batch production that are
generally used in the laboratory sector. Their special
feature: the same filling and closing methods are used as
in high-performance machines. B+S has now completely
updated its “smallest” products and is presenting them
for the first time at ACHEMA.
The patented single-hose
peristaltic pump
makes do with just one hose
per dosing station, which
make handling much simpler
and increases process
reliability.
2012
10 | we connect
Bausch+Ströbel acquires Swiss company Wilco AG,
thereby expanding its range of filling and packaging
equipment to include high-precision FULLY AUTOMATIC INSPECTION MACHINES for leak detection
and visual control as well as spectroscopic systems.
• EDM fillers are available not only rotary piston pumps, but
now also with peristaltic pumps. The newly developed
and patented single-hose pump has been deployed here.
• The SVP stoppering machine is also available in many
different versions. An automatic feed is now possible.
Another possible additional function is gas-flushing.
• A crimping unit and a combined screw-closing and crimping station has now become available with the HV series.
The KCP5060
is a specialized filling and
closing machine for small
batch production. Special
clean-room robots transport
the vials, syringes or
cartridges to the filling and
closing stations.
2013
2014
THE LARGEST BUILDING PROJECT in the company’s
almost 50-year history results in a new assembly
shop, a spacious order-picking warehouse, additional
rooms for seminars and customer meetings, offices and
a company restaurant with roof terrace.
Bausch+Ströbel has been manufacturing specialized machines for
the pharmaceutical industry for nearly 50 years. Its technology
offers massive benefits for the industrial processing of medicines
in liquid and powder form.
The machines made by this specialist company range from
semi-automatic machines for the laboratory to fully automatic
stand-alone units and even highly complex installations for
processing containers such as vials, bottles, syringes, ampoules
and cartridges. A large number of individual work steps have
to be carried out here, such as unpacking, cleaning and sterilizing
the items before they are filled, closed, inspected and labelled.
In addition to the basic models, all models are now also
available in enhanced versions offering even more convenience. It is possible, for example, to integrate 100 % IPC
with a scale. The filling quantity is automatically adjusted
during production. Batch logs can be stored, and an
interface for a printer is also available.
The new “small” models are perfectly matched:
These small units have been completely designed for use
in an isolator. All parts can withstand VHP sterilization without a problem, they are unaffected by hydrogen peroxide
vapour. Interesting combinations are possible with the
modular VarioSys system. In addition, the “new” models
can do more than their predecessors: for example, the
control system has been completely upgraded. Operators
can now conveniently carry out all adjustments on a
touchscreen. Parameters can also be stored and filed there.
SPECIALIZED MACHINES
FOR THE PHARMACEUTICAL
INDUSTRY
VarioSys
is a highly flexible production
solution. A wide variety of
modules for filling, dosing
and closing can be fitted
in special isolators using the
lock-and-key principle.
Bausch+Ströbel founds the B+S ACADEMY. The
processing of pharmaceuticals is becoming increasingly
complex, and high quality standards require welltrained personnel. B+S now offers its customers a
wide-ranging program of seminars and training
Bausch+Ströbel has steadily grown over recent decades, so that
approximately 1,100 employees now work at its Ilshofen site alone,
while its global workforce already exceeds 1,400. The company
maintains production sites in north Germany and the USA as well
as over 50 sales and service facilities worldwide.
In 2013 the company bought Wilco AG in Switzerland. Its fully
automatic high-precision inspection machines for leak detection
and visual control and its spectroscopic systems complement
the Bausch+Ströbel range perfectly.
courses. Among others, subjects include plant availability or overall
equipment effectiveness (OEE). The modular program is especially
tailored to address customers’ needs. The academy is also
responsible for ensuring the B+S team keeps abreast of the latest
developments in research and technology.
we connect | 11 FETTE COMPACTING
EFFICIENCY GUIDE – HOW TO INCREASE
EFFICIENCY IN TABLETING
Efficient tablet production is only possible when many factors are
perfectly matched: powerful machines, optimum processes and
well-trained personnel. Fette Compacting has tailored its products
and services to meet these requirements. In addition to a range
of tablet presses and process equipment for wide-rangin applications
from galenics to high-volume production to WiP and containment
solutions, the company also offers extensive support, consulting and
training services.
PARTNERS
Three Machines for Maximum
Tableting Productivity
The machines in the FE Series stand for the very highest
efficiency and quality standards in pharmaceutical production. They combine maximum performance with simple
operation as a result of Fette Compacting’s TRI.EASY
design. They have set completely new standards in tablet
production.
Like the other machines in the FE Series, it is very simple
to operate and offers short production changeover and
maintenance times as a result of its easy to fit components.
The FE75 complements the first two models in this innovative series – the FE55 and the FE35 – with a machine
that sets new standards for the production of large batches
of tablets.
With the FE Series, Fette Compacting began developing
tailor-made technologies to meet the highest efficiency
standards in tablet production in 2011. The most efficient
production solution depends on the product in hand. The
production of generic drugs, for example, requires high
quality at minimum cost. When it comes to products with
highly effective substances, on the other hand, special
precautions are required to protect operators.
TRI.EASY design – simple operation is the key to efficiency
One major feature of the FE Series is the new TRI.EASY
operating strategy. The underlying idea is straightforward:
technology can only be efficient if it is equally simple
to use in the three dimensions of operation, changeover
and maintenance. That is why the TRI.EASY design was
consistently devised to meet the needs of users, offeringextensive support in all tasks so that operating errors
are practically ruled out. Short training periods and significantly improved handling safety for operators ensure
the highest standard of product quality in even the most
demanding jobs.
In 2014, following the development of the FE75, Fette
Compacting rounded off the series and launched a machine
with the highest output: the double rotary press can
produce over 1.65 million tablets per hour – on a floor
space of just two square meters.
2011
12 | we connect
Fette Compacting celebrates the world premiere of
a new MACHINE GENERATION. A new COMPETENCE
CENTER opens in Goa, India. Fette Compacting is
therefore the first manufacturer of tableting technology
to offer a comprehensive service and training program
in India.
2012
It offers the fastest product changeover: Fette
Compacting launches the second tablet press in the
FE Series, the FE35, at ACHEMA. In the South American
Campinas opens a new COMPETENCE CENTER.
The company has developed a manual for its products and services
in the shape of the Fette Compacting Efficiency Guide. It covers the
three areas of Technology, Service and Competence.
Technology focuses on its tableting technology offering –
from tablet presses and process equipment to tableting tools.
Service encompasses all the services associated with
machines and equipment, such as spare parts supply, machine
modernization and technical field service.
Competence is the heading for all process-related services.
These include training courses, product trials, FMECA and OEE
consulting, and engineering.
INNOVATIONS
Using hidden performance reserve –
Fette Compacting is presenting its
new program for plant optimization
for the first time at ACHEMA 2015.
The total of four packages – Uptime,
Output, Quality and Yield – are
optimally tailored to address specific
production problems. Users benefit
from measurable improvements within
a very short time as well as a sustainable improvement in their machines’
processing of relevant products.
2014
Pmax Turret with FS12 punches – High
Performance for Tablet Production
Pmax turrets with FS12 punches
significantly boost productivity: they
enable users to increase tableting
output by up to 40 % – without
increasing production time. The turrets
with 45, 66 and 110 punch stations
are also available for retrofitting.
Fette Compacting rounds off the FE Series with
the world premiere of the FE75 double rotary press.
A new SUBSIDIARY commences work in Mexico.
In Nanjing, China, Fette Compacting celebrates its
10th anniversary.
2015
Global Customer Support – global
know-how on all aspects of tableting
Fette Compacting offers swift support
on all levels through a digitally networked service system. It covers
everything from pressing tools and
OEM spare parts to plant modernization
and refurbished machines to
worldwide training courses for your
employees.
Fette Compacting founds a new SUBSIDIARY in
Switzerland to expand local sales and service
capacities. In autumn, Fette Compacting opens a
new CUSTOMER AND COMMISSIONING CENTER
at the Schwarzenbek plant near Hamburg.
we connect | 13 PARTNERS
Realizing enormous
potentials
In the future many pharmaceutical products will be manufactured using continuous processes that offer enormous savings potentials. The production experts at Glatt
are now demonstrating the opportunities this approach
offers with the MODCOS continuous production line. One
innovation is central to this.
Scaling up batch processes – moving from laboratory to
pilot production and on to the smallest full-scale production
– is very time-consuming. In continuous processes, however, the procedure runs fully automatically. Against this
background, the MODCOS production line offers enormous
savings potentials.
PROCESS INNOVATIONS
The Glatt rotary process unit makes it easy to move from stepped batch to integrated
continuous production: it enables batch fluid bed machines of the GPCG 2 and
CPCG 10 series and larger to be converted into continuous fluid bed granulators.
Afterwards the time the product spends in the machine can be very precisely controlled
– and that guarantees high quality. An ingenious automatic discharge system also
provides process reliability.
FROM PRODUCT DEVELOPMENT
TO PLANT ENGINEERING
Modular expansion of existing machines
The decisive innovation here for many users is Glatt’s new
process unit. It makes it easy to convert existing batch units
in the GPCG2 and GPCG 10 series into continuous fluid
bed machines. Afterwards it is possible to precisely control
the time products spend in the machine. Investment in a
new machine is no longer required.
Glatt is one of the world’s leading suppliers of
fluid bed systems, high-shear granulators,
granulating lines and tablet coaters. Additionally, the company also offers a wide range of
services and technological solutions.
Werner Glatt built his very first fluid bed
system for the pharmaceutical industry with
a dozen employees in 1959. Today, the
company employs more than 1,500 people
at facilities in Germany, the USA, Switzerland, India, Russia, the UK, China and the
Czech Republic. The goal of the specialists
who work for the Binzen-based company
has remained unchanged over the years:
continuously improving the standard of
technology and developing highly efficient
production solutions.
High-safety integrated system
The integrated process of the continuous production line
begins with micro-dosing units for powders and microgranules. Then the necessary granules are manufactured in
a twin-screw granulator. Drying is carried out in a Glatt
fluid bed machine with the new rotary chamber. After further
mixing processes, final tablet production begins. The
entire process is continuously monitored by PAT systems
and, if necessary, automatically adjusted by appropriate
control loops. This creates a very safe and stable process.
Glatt is organized in four divisions:
• Pharmaceutical Services develops and
produces solid dosage forms as a service
provider. Key areas here are multiple
unit dosage systems such as pellets and
micropellets as well as granules.
2013
14 | we connect
Construction of the new TECHNOLOGY CENTER begins
in July 2013 at the headquarters in Binzen. It is
also planned to extend the production plant during the
second construction phase.
2013
In mid-2013, Glatt takes over a modern production
operation in Pune, India. The facility is meant to help its
sales and service organization to develop BUSINESS
IN INDIA. An additional office, which is maintained jointly
with Fette Compacting and Harro Höfliger in Mumbai,
helps provide optimum customer support.
2014
The first Glatt CONTI PRODUCTION LINE
MODCOS is produced, delivered and successfully
begins operation.
2015
• Process Technology Pharma develops
fluid bed systems, high-shear granulators, granulation lines and tablet coaters.
Glatt developed its original core business
in a targeted way, expanding it to include
important processes in the production
of pharmaceutical solids – from weighing
materials to the transfer to packaging
and associated product handling steps
in the production chain.
• Process Technology Food, Feed & Fine
Chemicals develops, plans and markets
fluid bed and spouted bed systems for the
food, animal feed and chemical industries.
• Process & Plant Engineering plans and
realizes plant engineering projects worldwide. Its range of expertise covers the
expansion and conversion of existing
facilities to the partial or total construction of newbuild plants.
With the launch of GCC, THE NEW BENCHMARK IN
COATING, Glatt introduces its new coater at ACHEMA.
Glatt sets new standards in drum coating with
TOP SPEED, TOP PRECISION, TOP UNIFORMITY, TOP
FLEXIBILITY and TOP HYGIENE.
we connect | 15 PARTNERS
Technology Made to Measure
Although dry powder inhalers (DPIs) are often very similar
in appearance, there are considerable differences in
their functional structure. This presents a major challenge
when designing machines to perform filling, assembly
and control processes. Here Harro Höfliger relies on a
flexible and robust platform technology.
MOT (Modular Oval Transfer System) is a proven machine
platform because it not only permits the use of individual
processes and methods, but also delivers a high degree of
standardization. The MOT system offers an ergonomic
arrangement of numerous stations in a very small space.
The entire machine footprint around the oval transport
system is used. Complex assembly jobs with integrated
powder dosing for DPIs can be performed in addition
to conventional assembly processes.
Up to 8 parallel tracks and a maximum speed of 40 cycles
per minute facilitate a very high output. The machine
can also be equipped with a barrier system adapted to the
respective requirements.
[ ALL YOU NEED ] –
WHAT HARRO HÖFLIGER OFFERS
The flexibility and reliability of the MOT machine platform
has been proven with very different products:
From a one-man show to a technology leader in many fields – Harro Höfliger, a specialist in
pharmaceutical production and packaging machines, is continuing its expansion course.
• Reservoir-based powder inhalers (DPIs)
• Autoinjectors and pen systems
• Medical technology products with complex structures
Approximately 900 employees achieved a turnover of € 160 million in 2014. The export
quota was 75 %. On one hand, the international success of the company with sites
in Canada, China, France, Russia, Switzerland, Singapore and the USA is based on growth
in the core business of developing customized solutions. On the other hand, it is
the result of Harro Höfliger’s ongoing specialization: the company excels with specialist
knowledge, technical support and production assistance. Harro Höfliger has long since
become the technology leader when it comes to machines for product assembly,
for the processing of web materials and for the filling and assembling of powder inhalers.
Guaranteeing safety with pharma services
Materials and substances containing active agents are tested for their process capability
as part of the company’s extensive service offering. Harro Höfliger has a wide variety
of testing machines and units available for this purpose at its headquarters. These can
be used to investigate the original product under actual production conditions – including
test runs with customer’s machines in a pharmaceutical production environment. This
guarantees safety and reliability. The motto “ALL YOU NEED” says everything about
Harro Höfliger. This means that Harro Höfliger stands by their customers with technological
support to ensure that the solutions are 100 % tailored to meet their requirements.
The fundamental qualities INVENTIVE. QUALIFIED. RELIABLE. reflect the principles that
Harro Höfliger upholds when realizing customer-specific system solutions.
SYSTEMATIC INNOVATION
2014
16 | we connect
The HH Academy opens its doors in June 2014. With
its new TRAINING CENTER Harro Höfliger lays the
foundation for a forward-looking training system.
More than 70 young people concentrate on training
for the future at the over 800-square meter facility.
2014
On 1 October 2014, Harro Höfliger founded the 100 %
SUBSIDIARY HARRO HÖFLIGER MENA S.A.R.L, which
now also offers local assistance and direct service
in the MENA regions (Middle East & North Africa).
An innovation management system is being implemented
at the Harro Höfliger company in order to promote and
coordinate strategic development. The size of the business
and the wide variety of technological fields demand new
processes and increased innovation. The advantage is that
strategic projects and research & development activities
are based on principles that build on the firm’s strengths and
apply them in a targeted way. The involvement of selected
experts from different fields, the coordination of activities
and active support from the management are major
pillars and factors for success. As a rule, an innovation
project goes through four phases from the preliminary
analysis of a proposal’s potential to the detailed examination of its functionality and practicality to the productionready Harro Höfliger technology.
2014
Shaping the future: Harro Höfliger becomes active in another technology
center offering over 3,500 square meters of space after taking over
an almost new PRODUCTION FACILITY in Backnang. Harro Höfliger
is optimizing the production and assembly of capsule-filling machines
here. It aims to become even faster and more efficient in order to
grow with its customers.
Harro Höfliger expands its global
network with the foundation of new
SALES AND SERVICE OPERATIONS
in Scandinavia, Turkey, Korea and
Mexico.
2015
we connect | 17 INNOVATIONS
AUTOMATED
PACKAGING PIONEER
For over six decades, Uhlmann has been advancing the development
of packaging technology in the pharmaceutical industry with
highly innovative solutions – and is ideally equipped to master with
the challenges of globalization.
Uhlmann packaging specialists have repeatedly demonstrated their
innovative strength over the years: the world’s first universal strip
packaging machine (1956), the world’s first pharmaceutically compliant
bottle filler for tablets (2008) and the Blister Express Center 500
as a complete system consisting of blister and cartoner module (2012)
are just three of numerous examples. Approximately 8,000 packaging
machines and production lines from Laupheim, not far from Ulm, are
currently in use worldwide. The export ratio is roughly 80 %.
PARTNERS
Packaging Tablets
Efficiently and Flexibly
Flexibility is especially important in the field of pharmaceutical packaging technology. A large number of different
products often have to be processed on a single line –
swiftly, economically and flexibly. One Uhlmann solution
sets new standards.
A total of 72 different packaging combinations and a large
number of secondary variants form the impressive packaging
solution for one hormone drug. At the German plant of
an Uhlmann customer there are two identical production
lines, consisting of a blister machine, pillow pack machine,
cartoner and stretch-banding machine. The lines are
configured in such a way that the pharmaceutical manufacturer can respond flexibly and cost-effectively to the
needs of its customers. “In addition, we have developed
the lines so that a changeover of product variants from
one line to the other is possible without any problem,”
explains Christian Link, Head of Customized Packaging
Systems. “Depending on the packaging variant, the
blister machine processes up to 400 blisters per minute.”
300 cartons per minute
Even at high speeds, the two lines guarantee production
reliability. Feeders accurately place the tablets in the
individual blister pockets. A camera inspection system
then checks correct filling. The integrated downstream
cartoner processes the individual blisters using a dancer
magazine or the finished pillow packs using a doublelane stacking belt feeder.
Assisted start of production
Uhlmann experts not only configured the production line,
but also accompanied start of production and trained
the operating personnel. “We ensure that the customer
production processes run smoothly from the very start,”
explains Christian Link.
Center: The Blister line BEC 500 processes up to 500
blisters and a maximum of 450 folded cartons per minute.
A Case packer E 4012 then packs 500 cartons into
12 transport cases per minute. All the modules in the
line are optimally coordinated.
Proximity to customers, proximity to the market
The experts also offer an extensive range of services. Uhlmann
Customer Services ensures smooth machine operation over
many years. Against this background, the experts have subsidiaries
in the USA, Brazil, the UK, Sweden, Spain, Russia, Switzerland,
France, Singapore and China. Furthermore, Uhlmann maintains a
competence center at its headquarters in Laupheim, which
guarantees maximum reliability and productivity in the pharmaceutical manufacturing and packaging process with innovative
inspection and printing systems.
Bottom: From the bottle to the pallet. the Bottle line
IBC 120, Labeler L 180 and Case Packaging Center 10,
combining a case packer and a palletizer.
2012
18 | we connect
Top: Added performance, improved user-friendliness and
greater application versatility. The new Blister line BEC 300
is the outcome of many optimization measures as well
as specific feedback from the market. For a maximum
output of 300 blisters and 150 cartons per minute.
Uhlmann sets a new standard in flexible and
efficient packaging of solid dose products with
its Blister line BEC 500.
2015
After 5 years, with more than 150 machines placed
on the market, Uhlmann is presenting the new Blister
line BEC 300 at the ACHEMA.
2016
Uhlmann is investing a double-digit million
euro sum in new buildings at its HEADQUARTERS
in Laupheim over the next few years.
we connect | 19 EU04 E
www.excellence-united.de
Bausch+Ströbel
Maschinenfabrik Ilshofen GmbH & Co. KG
Parkstrasse 1
74532 Ilshofen
Germany
www.bausch-stroebel.com
Fette Compacting GmbH
Grabauer Strasse 24
21493 Schwarzenbek
Germany
www.fette-compacting.com
Glatt GmbH
Werner-Glatt-Strasse 1
79589 Binzen
Germany
www.glatt.com/en
Harro Höfliger
Verpackungsmaschinen GmbH
Helmholtzstrasse 4
71573 Allmersbach im Tal
Germany
www.hoefliger.com/en
Uhlmann Pac-Systeme
GmbH & Co. KG
Uhlmannstrasse 14–18
88471 Laupheim
Germany
www.uhlmann.de/en