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packazinePHARMA · Issue 02/2009
Siemens Healthcare Diagnostics | Hermetically sealed packagesHameln pharma | Fast delivery and high quality serviceKneipp | High-tech meets tradition
2 | packazine Table of contents | Editorial
www.boschpackaging.com [email protected]
News
Facts & Trends
04 Safety and quality increase brand value
Customers & Markets
Pharma & Cosmetic
06 Siemens Healthcare Diagnostics | A compact system for
hermetically sealed packages
09 Hameln pharma | Fast delivery and high quality service
deliver pharma success
12 Pharmatec | Pharmatec supplies preparation equipment
for basic fractionation to Russia
14 Kneipp | High-Tech meets tradition
Events
23 Events Pharma 2009/2010
Cover
Bosch – your reliable partner for
pharmaceutical solutions
04 06 09
Customer magazine of the Packaging Technology Product Division Robert Bosch GmbH
Editor in ChiefCentral MarketingUlrike ProbstPhone +41 52 674 80 [email protected]
DesignBOHNER.concept · agency for creative communication & design
PhotosOtlinghaus Fotodesign; Bosch Packaging Technology
PublisherProduct Division Management, Stuttgarter Straße 130, D-71332 Waiblingen
© Copyright · Packaging Technology Product Division Robert Bosch GmbH
The contents of this publication may not be reprinted except by permission.Subject to alterations.
Imprint
packazine
Tableof contents
packazine | 3
Dear Readers
The pharmaceutical industry is going through a time of radical change. On the one
hand, it is obliged to invest in production processes due to government regulation.
On the other, important sales pipelines are weakening because of
expiring patents, which is shifting interest towards the production
of generic drugs. The consequence of this market situation is
rising cost pressure which, in the short term, may be averted
mainly through increases in productivity. On the product side,
there is an important trend towards therapeutic medication.
For instance, in oncology, cytostatic drugs are used, the
production of which places high demands on machines as well
as processes. The same applies to biotechnology, which mainly
uses expensive substances requiring new machine concepts, for
processes such as accurate dosing.
In light of these developments, machine manufacturers are important partners for
the industry because they create solutions based on safety, high output, flexibility
and cost-effectiveness. Bosch Packaging Technology is a company which has been
generating success for decades through its reliable quality, its power of innovation,
as well as its financial strength. Our customers all over the world are putting their
trust in Bosch’s efficiency in providing solutions, particularly in the fields of process
technology, primary and secondary packaging, qualification and services.
This latest edition of our packazine magazine again contains details on a number of
interesting customer projects. We also keep you up to date on important new trends
and their impact on the packaging industry.
I hope you enjoy the read.
Friedbert Klefenz
14
Friedbert Klefenz
President
Bosch Packaging
Technology
Editorial
4 | packazine News Facts & Trends
packazine | 5
When brand owners decide to explore
new markets, they need to be sure their
brand is robust in terms of product
quality and safety. In order to win over
new consumers, proven and trustworthy
production facilities and equipment are
absolutely essential. This is especially
true in the tightly regulated world of
pharmaceuticals.
Market researcher RNCOS‘s latest
forecast predicts that the value of the
global pharmaceuticals market will
expand by 8 % annually1. Another recent
study believes that this market will be
worth over US$ 1000 billion, or one
trillion dollars, by 20122, driven largely
by growth in emerging economies such
as India and Eastern Europe. A lack of
domestic, high-end technology in these
markets creates enormous potential for
innovative processing and packaging
equipment manufacturers, as they are
able to help brands establish a positive,
safe and reliable reputation in unfamiliar
marketplaces.
Investors and businesses in emerging
markets know that partnerships with
well-known manufacturers immediately
elevate them to a competitive position.
For instance, working with Bosch Pack-
aging Technology conveys the image of
reliability, safety and proven technology
to the buyer. Packaging experts under-
stand the strengths of pharmaceutical
brands and how best to emphasize them.
Patents and the brand value are the most
important assets that pharmaceutical
companies possess. Both need to be
handled with care, particularly when
expanding commercial operations.
Brand value is enhanced enormously
by up-to-date packaging, allowing ambi-
tious businesses to gain a foothold in
emerging markets. Market research
consistently shows that consumers draw
a direct link between packaging quality
and the quality of the product it contains.
Innovative packaging also helps to
uphold pharmaceutical patents. Increas-
ingly sophisticated counterfeiting
techniques pose a growing threat to
pharmaceutical brands, both in terms of
lost sales and potential damage to cred-
ibility. Even strong patents are at risk
from black market manufacturers, who
compromise on safety and quality under
the name of a legitimate brand.
Strategies to confront this problem
can be bolstered by the adoption of
anti-counterfeiting packaging solutions.
Through new packaging technologies, the
threat of imitation is virtually eliminated.
Success in a one trillion dollar market
depends on the ability of brand owners
to create awareness and gain the trust
of consumers. Of course, trust in a phar-
maceutical brand lies in the product’s
efficacy; but it also depends on product
safety and reliability.
The one trillion dollar market opportunity
calls for high-end packaging and process-
ing equipment as a foundation for
success. Investment in reliable packaging
solutions is the smart way to ensure that
this opportunity is not missed.
For more information please contact:
Ulrike Probst
Phone +41 52 674 8053
Safety and quality increase brand value
1 http://www.rncos.com/Market-Analysis-
Reports/Global-Pharmaceutical-Market-Fore-
cast-to-2012-IM149.htm2 http://www.prlog.org/10202855-bric-eastern-
european-nations-lead-global-pharma-sector-
amidst-recession.html
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sum diamet ing ero conse-
nibh eugue dolore
6 | packazine Customers & Markets Pharma and Cosmetic
1 Infeed chain as well as infeed of
desiccants
2 MTP labeling with following
barcode verification
3 Horizontal pillow pack machine
HBL for hermetic sealing
1
packazine | 7
Sigpack Systems, a Bosch Packaging
Technology company, has supplied
Siemens Healthcare Diagnostics with a
compact packaging system for hermeti-
cally sealed packages.
Siemens Healthcare Diagnostics is the
world largest company specializing in
clinical diagnostics. It offers products
and services for the efficient provision
of tests for diagnosing diseases and
monitoring patient care. The company‘s
broad product portfolio offers a wide
choice of analysis systems.
In diagnostics, Siemens has invested in a
new packaging system for microtitration
plates (MTP). At its Marburg location in
Germany, the company produces MTPs
for worldwide distribution. Its principal
clients are blood donor centers, labora-
tories and clinics.
System requirements
The main task was to transfer the
product to an upstream machine, label
it using a labeling unit provided by Sie-
mens Healthcare Diagnostics, and then
guide it to the packaging machine via a
transportation belt system. Other tasks
were the insertion of a desiccant bag
and the integration of a camera system
for printed image control.
As would be expected in pharmaceutical
primary packaging, the principal require-
ment of the packaging material was its
complete tightness.
Packaging line
After passing the upstreaming produc-
tion line the MTPs are transferred to
an accumulation area alongside the
labeling unit, where labels are attached
in predetermined positions. At the same
time, the bar codes are checked by a
vision system. In case of missing labels
or unreadable bar codes, the product is
ejected and the successful ejection is
verified. Then, the MTPs are transferred,
via transportation belts, to the infeed
chain of the HBL horizontal pillow-pack
wrapping machine.
The MTPs are then pushed at a 90° angle
into the infeed chain. During this opera-
tion, the desiccant bag is inserted via a
Microtitration plates in pillow packs
A compact system for hermetically sealed packages
2 3
8 | packazine Customers & Markets Pharma and Cosmetic
dispenser fitted with a cutter. Together
with the desiccant bags, the MTPs are
then hermetically sealed as pillow packs.
Batch number, date and product type
are printed on the foil. A Cognex vision
system then reads the printed data
(OCR). Finally, there is a further check
for any faulty products, which are ejected
with verification.
For more information please contact:
Benjamin Leins
Phone +41 52 674 7268
Interview with Timo Vaupel (Head of MTP manufacturing
division, left in the picture) and Tobias Schaub (production
engineer, right) at Siemens Healthcare Diagnostics.
What were the principal reasons behind this new invest-
ment?
One reason was that the existing machine was ageing and
had become increasingly susceptible to faults. Another
reason was our intention to change our packaging concept,
which would not have been possible with the old installation.
Why did you change your packaging style from aluminum
trays to horizontal pillow packs?
The aluminum trays had the disadvantage that we had only
one supplier. The change meant that we gained more flex-
ibility in the choice of supplier, but we also took account of
a study which showed that huge savings could be made by
using flexible foil. As a result, we opted for the pillow pack
solution.
Why did you choose Sigpack Systems as your partner?
Very important, of course, was what we had seen for
ourselves. In particular, we were won over by the detail
engineering and the progressive refinement of products, even
under time pressure. We consistently increased our demands
but Sigpack Systems, time and again, came up with convinc-
ing solutions. Despite a tight timeframe of only four weeks,
the delivery of the project was spot-on: disassembly of the
old unit, assembly of the new installation and, of course,
qualification in order to ensure speedy recommissioning of
the entire line. The result speaks for itself.
Why would you recommend Sigpack Systems?
We deliberately went for the best offer overall and did
not automatically opt for the cheapest solution. It was an
ambitious project and we needed to be sure that we had a
supplier that would be able to support us in every aspect.
With Sigpack Systems, we had this assurance from the start.
The cooperation was solid, professional and based on trust.
We have achieved all our objectives and are more than happy
with the result.
1 Product infeed from upstreaming
production line respectively manuel
product infeed
2 Labeling unit an vision system
3 Cross transportation with product
orientation
4 Desiccant dispenser
5 Horizontal pillow pack machine HBL
for hermetic sealing
6 Checkweigher
1
4
5
6
2
3
packazine | 9
Hameln pharma, part of the Hameln Group, has focused on the development, production and distribution
of pharmaceuticals for over 50 years. Specializing in the contract manufacturing of parenteral medicines
predominately used in hospitals and intensive care, hameln pharma has worked with Bosch Packaging
Technology for many years. Currently, the oldest Bosch ampoule line still in use was purchased in 1985.
Fast delivery and high quality service deliver pharma success
Fast delivery
In 2006, hameln pharma decided to
build a new sterile facility to increase
the production capacity in Hameln,
Germany. Additional filling lines were to
be installed so hameln pharma needed a
reliable supplier of vial and ampoule fill-
ing lines with short delivery times. Other
critical process parameters included
compact design, energy efficiency
and short training times. After making
comparisons, hameln pharma decided
on Bosch.
In November 2006, hameln pharma
ordered a vial filling line equipped with
a universal washing machine, drying
and sterilizing tunnel, filling and closing
machine and capping machine. Bosch
delivered the line within 12 months.
Another ampoule filling line was ordered
from Bosch in April 2007 which was
equipped with a universal washing ma-
chine, drying and sterilizing tunnel, filling
and sealing machine and color coding
machine. Bosch delivered this second
line in December 2007, an even shorter
delivery time than for the previous order.
Increased productivity
The most important features of the vial
and ampoule lines are the U-Shape with
a wall installation, and the inclusion of
Restricted Area Barrier Systems (RABS)
and Cleaning-In-Place and Sterilizing-In-
Place (CIP/SIP).
To achieve maximum production effi-
ciency, the vial and ampoule lines are set
up in a U-shape with a wall installation.
This greatly reduces the space required
in the highest cleanroom class. The
cleanroom class zone grade A can be
kept smaller when using wall installed
machinery. Furthermore, maintenance
measures inside the filling and closing
10 | packazine Customers & Markets Pharma and Cosmetic
1 2
Vial filling and closing machine FLC 3060 with
RABS at hameln pharma
1 Opening of stopper bags under
laminar flow
2/3 Closing station of the ampoule
filling and closing machine
ALF 40804 Container infeed at the washing
machine RRU 3084
packazine | 11
machines can be partially carried out
from cleanroom zone grade D, which
reduces the contamination risk in zone
grade B during maintenance, or in case
of repairs.
Another benefit of the U-shape with
the wall installation is that there is less
movement needed for the operators
in the cleanroom, especially between
different cleanroom zones, which in-
creases productivity and efficiency. The
monitoring of the actual filling process
in cleanroom class A can be performed
by an operator that remains in the neigh-
boring class B cleanroom.
“We had extensive meetings with Bosch
at machine manufacturing sites in
Crailsheim, Germany, and at Hameln to
discuss our needs during the project
planning, and we are very satisfied with
Bosch’s fast delivery of vial and ampoule
filling lines with our required U-shape
and wall installation. This helps us to
increase productivity and efficiency
while meeting the cleanroom standards.”
says Dr. Simone Dahlmanns, Operations
Director of hameln pharma.
RABS further reduces the risk of con-
tamination in the cleanroom zone grade
A, since most of the production process
can be carried out with the doors closed.
Additionally, the filling machines are
equipped with CIP/SIP equipment which
further reduces the risk of contamina-
tion.
With the Bosch lines, hameln pharma will
expand its production capacity to handle
a broader variety of container formats,
batch sizes, potencies, formulations and
product types. The efficient and flexible
sterile facility has won the 2009 Facility
of the Year Award for Operational Excel-
lence.
“We have always trusted the reliability of
the machines and the service provided
by Bosch. The quick response time from
Bosch in answering questions, replying
to our urgent requests and supplying
solutions for special needs was critical
to the success of this project. The lines
from Bosch have created a positive expe-
rience for us, based on the reliability of
the machines. Furthermore, the modular
build of the machines allows for lower
storage levels of spare parts in Hameln
and, in urgent cases, Bosch can deliver
critical parts within 24 hours,” says
Dr. Dahlmanns.
For more information please contact
Andreas Bühler
Phone +49 7951 402 537
3 4
Preparation equipment for
basic fractionation
12 | packazine Customers & Markets Pharma and Cosmetic
In October 2007, Pharmatec, a Bosch
Packaging Technology company, was
selected by a Russian customer to under-
take the detailed planning of preparation
equipment for basic fractionation, as
well as fractionation equipment for
albumin and immunoglobulins. In March
2008, the company received the contract
to produce this equipment and further
installations. In addition, the preparation
equipment for the thawing of blood
plasma, was also delivered by Pharmatec.
Blood plasma fractionation
Blood plasma fractionation requires the
separation of plasma phase proteins
using physical and chemical procedures.
The critical parameters in this process
are temperature, alcohol concentration
and pH-value.
The first step in blood plasma process-
ing is a gentle thawing process, while
maintaining strict temperature control.
The plasma fractions are then separated
by means of filtration, centrifugation and
other procedures.
Plant technology and main equipment
The core components of the supplied
equipment are special preparation and
buffer vessels for thawing, storage, mix-
ing, precipitation and reaction. Designed
pipe systems and operator-friendly trans-
fer panels ensure an optimal product
flow. A further pipe system provides all
processing equipment and installations
with the required media and energy.
At the heart of the fractionation equip-
ment are fourteen process vessels with
a capacity of up to 17 cubic meters.
Each vessel rests on weighing cells, is
equipped with measuring technology to
determine product flow, temperature
and pressure, and also has its own
temperature control. The preparation
equipment, as well as the pipework with
product contact is made of high quality
stainless steel. All pipes with product
Pharmatec supplies preparation equipment for basic fractionation to Russia
packazine | 13
contact and high-purity media contact,
as well as all fixtures, are cGMP compli-
ant, and all welding has been carried out
observing the 3D rule.
High level automation
Pharmatec installations ensure that all
important parameters are monitored
by a powerful control and process
visualization system. The control system
ensures registration and documentation
of all process-relevant data, steps and
parameters.
Testing and cleaning
An important aspect of quality-oriented
pharmaceutical production is an inte-
grated cleaning system (CIP). Pharmatec
uses high-performance cleaning con-
cepts which are designed for customer
specific needs. Two CIP plants were sup-
plied for cleaning the equipment, each
comprising two stainless steel vessels
(capacity: 1–2 cubic meters).
All preparation and cleaning programs
are product-specific and were tested at
Pharmatec in Dresden for thawing and
basic fractionation processes.
One-stop solution
Well thought-out configuration and
flexible orientation towards the custom-
er‘s requirements enabled Pharmatec
to supply the preparation equipment for
the basic fractionation as well as the
additional, separately commissioned
thawing installation on schedule in
November 2008.
For more information please contact:
Michael von Papen
Phone +49 351 28278 35
Blood plasma (circa 55% of the human blood)
Thrombocytes and white blood cells
Red blood cells
14 | packazine Customers & Markets Pharma and Cosmetic
Main Infeed Station
packazine | 15
Kneipp is a traditional brand and stands
for effective, innovative and natural
product concepts promoting health
and well-being based on the integral
medicine of Sebastian Kneipp. Naturo-
pathic competence and pharmaceutical
experience, state-of-the-art production
techniques and careful scientific controls
are at the heart of Kneipp’s products,
which are proven over generations.
Today, the Kneipp group is a global com-
pany with around 350 associates and is a
100 % subsidiary of PAUL HARTMANN AG,
Heidenheim.
At its location in Ochsenfurt near Würz-
burg Kneipp produces cosmetic products
such as lotions and bath oils as well
as food supplements and plant-based
pharmaceuticals in tablet or pill format.
Kneipp products stand for proven
effectiveness and high-quality natural
ingredients.
New packaging solution
In order to rationalize its operations,
as well as secure health improvements
for its associates, the existing manual
packaging operations were to be auto-
mated at Kneipp’s production facility in
Ochsenfurt, near Wurzburg. The chosen
solution was an automatic case packing
unit from the ELEMATIC 1000 WA-i series by Paal Verpackungsmaschinen, a
Bosch Packaging Technology company.
The Paal packaging installation gives the
operator flexible machine utilization,
combined with easy and repeatable
format adjustments. As a result of its
completely modular design and servo
drives, these fully repeatable format
changes can be made via a touchscreen,
without any major manual input.
The machine infeeds blanks at an
ergonomically convenient height. With
a capacity of up to 400 blanks, the
height-adjustable carton magazine does
not require the constant presence of
an operator. Even during the largely
independent production process, all
parameters can be changed at the push
of a button.
The special grouping system developed
for the Paal ELEMATIC 1000 WA-i is
arranged in such a way that different
sizes, as well as shapes, of bottles can
be processed. Of particular importance
to Kneipp was the congestion-free func-
tioning of the grouping system, which
ensures safe operation especially with
oval-shaped bottles.
Optimum accessibility
Also important was the compactness and
small footprint of the new installation.
The Paal ELEMATIC 1000 WA-i allows
single-page operation of all functions
and for the key-operator all areas of
Kneipp selects modern case packing unit by Paal
High-tech system enhances traditional values
1 Case Packer
ELEMATIC 1000 WA-i2 Blank Infeed
16 | packazine Customers & Markets Pharma and Cosmetic
operation can be seen in an optimal way
even from greater distances.
Part of the project at Kneipp also in-
volved changing the type of packaging for
bath oils. In the past, RSC folding boxes
had been used but now, as part of the
automation process, Kneipp was aiming
for packaging with wrap around cases
from flat blanks.
New packaging style
In the course of changing the packaging
style from RSC folding boxes to the flat
blank, Kneipp profited from using the
Paal Competence Center for packaging
development, which is available to all
of Paal‘s customers. Paal was able to
offer Kneipp a complete package: first
drafts, pre-production samples, trade
presentations and, finally, the first
machine-usable blanks.
A flexible future
Another crucial factor for Kneipp was the
flexibility of the 1000 WA-i series, which
will create any type of packaging - simple
tray, full wrap around or décollate
case – from a single blank. Should an
installation capable of two-part packag-
ing be required, the other versions of the
Paal ELEMATIC 1000 WA-i would allow
expansion with additional magazines
capable of producing trays with inner or
outer hoods.
Fast assembly
The installation was assembled and
equipped for all formats within a week.
Simultaneously, all of the machine‘s
prospective operators were trained.
As a result of the complete package
offered by Paal and the advances made
possible by the new system, Kneipp has
been more than satisfied that it took
the right decision by acquiring the Paal
ELEMATIC 1000 WA-i and is determined
to continue with Paal as its technology
partner.
For more information please contact:
Jochen Dietrich
Phone +49 7151 700767
1 2
packazine | 17
Bosch. Your Pharma Competence Center.
Bosch Packaging Technology is the world’s leading supplier of complete solutions for process, filling and packaging technology. Based on comprehensive consulting and project planning know-how, our service range also includes modules, systems and complete solutions. Our product range is rounded off perfectly by individual service solutions.
Bosch Packaging [email protected] | www.boschpackaging.com
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