packazine
PHARMA · Issue 01/2009
Axellia | Filling first, packaging after
Sanofi-Aventis | Ultimate quality control
Bayer | Turnkey system solution for Aspirin® Effect
2 | packazine Table of contents | Editorial
Table
of contents
06
08
News
Facts & Trends
04
Interdisciplinary knowledge exchange for pharmaceutical packaging and processing
06
Meeting the challenges of an ageing population
Customers & Markets
Pharma & Cosmetic
08
Axellia | Filling first, packaging after
12
Pharmatec | New fermenter for multipurpose use in pilot plant stations
14
Sanofi-Aventis | Ultimate quality control through 100% control
16
Bayer | The classic Aspirin® gets a makeover
Events
18
Events Pharma 2009
Cover
Aspirin® Effect – packed in a
convenient stick pack
www.boschpackaging.com [email protected]
packazine | 3
12
Editorial
16
Dear Readers,
A look back on last year shows that we were extremely successful. In 2008, our associates generated sales of around 700 m Euros, which represented a sales increase
of around eight percent. This powerful development makes us proud
and underlines our technological leadership position. Above all,
however, it is firm proof of our customers’ trust.
Friedbert Klefenz
President
Bosch ­Packaging
Technology
Long-term customer trust is important to us. In particular, in difficult
economic times, Bosch is a reliable partner. As a one-stop shopping
supplier, we offer solutions along the whole value added chain and
provide the highest safety, flexibility and optimal total cost of ownership.
We are happy to personally convince you of our know-how and look forward to seeing
you at Achema 2009, in Frankfurt. In hall 3.1, we will show you tried and tested and
forward-looking solutions from five areas of competence: processing technology,
primary and secondary packaging, qualification and services. It is not just our stand
at the exhibition that will be impressive. Our lectures at the Achema conference are
not to be missed either and will include informative presentations such as “Medical
­Confectionery – medicine packed into sweets” and an analysis of “Bio-decontaminations and their influence on production processes”.
In preparation for Achema, we present some interesting customer projects in this
edition of “packazine”. You will also find important information relating to trends and
their influence on the packaging industry.
We look forward to continuing our successful partnerships with you.
I hope you enjoy the reading,
Friedbert Klefenz
4 | packazine News Facts & Trends
Interdisciplinary
knowledge exchange
for pharmaceutical
packaging and processing
Pharmaceutical manufacturers around the world consistently turn
to Bosch Packaging Technology for innovations in packaging and
processing technology. They benefit from decades of expertise and
Under the Bosch umbrella, the pharmaceutical businesses comprise of product
brands such as Moeller & Devicon,
Pharmatec, SBM Schoeller-Bleckmann
knowledge in optimizing production processes and safety, enhancing
Medizintechnik, Sigpack Systems and Va-
efficiency and reducing total lifetime costs.
licare. United, we serve customers in the
pharmaceutical and biopharmaceutical
industry.
The individual strengths of the group,
with sites across the globe, account
for Bosch’s position as a global leader
with one of the most comprehensive
technology and service portfolios in the
Come and experience Bosch at the ACHEMA convention.
Visit our lectures.
12th May 2009, 3.30 pm, Konstant Forum:
Influence of Humidity, Concentration and Condensation on Efficacy and Penetration in
Bio-Decontamination Processes Applying H 2O2 Vapor
12th May 2009, 4.30 pm, Konstant Forum:
Electron Beam Sterilization of Tubs with Nested Syringes – Challenges and Innovation
12th May 2009, 5 pm, Agenda Forum:
Medicated Confectionery – Technological Challenges and Solutions
14 th May 2009, 10.30 am, Illusion 3, CMF:
Image Processing as Useful Technology in the High-Throughput Analysis of Formulations
and Coatings
Visit us in Hall 3.1, Stand F2 – J11.
For more information please visit www.boschpackaging.com
industry. The interdisciplinary approach
Bosch Packaging Technology
of Bosch
directs
an| international
Moeller
& Devicon
| Pharmatec
SBM Schoeller-Bleckmann Medizin-
network of engineers to optimize project
technik | Sigpack Systems | Valicare
execution and integration processes for
customers.
The company’s strengths can be divided
into five key areas of competence:
process technology, primary packaging,
secondary packaging, qualification and
services.
packazine | 5
} Process Technology
} Secondary Packaging
Bosch’s process technology expertise
For secondary packaging, Bosch offers
equipment. Bosch Packaging Services
combines aseptic and sterile processing,
cartoning and toploading systems,
is determined to meet future market
which includes equipment, container and
flow wrapping machines with hermetic
requirements to reduce total cost of
product sterilization, isolator systems
sealing, and end-of-line packaging equip-
ownership and protect capital equipment
and restricted access barrier systems
ment. This product range enables custo-
investments.
(RABS). Equipment for clean facilities
mers to work with Bosch from primary
that produce, store and distribute
packaging to end-of-line applications.
Our Promise
the portfolio to serve customers from
} Qualification
is to continue its leadership role in the
biopharmaceutical to medical device
Part of Bosch’s full service offering also
pharmaceutical industry with innovative,
industries. Furthermore Bosch offers
includes qualification and validation
reliable and economical solutions.
production and forming lines for medi-
services for laboratory equipment as
Bosch’s overall objective and driving
cated confectionery and other formable
well as manufacturing processes for
force is enabling customers to get one-
masses.
pharmaceutical, biopharmaceutical
stop-solutions and create sustainable
and life science applications. To meet
business growth through state-of-the-art
sterile and aseptic products complete
maximize the availability of production
Bosch Packaging Technology’s promise
} Primary Packaging
international qualification requirements,
services, processing and packaging
Primary packaging is an essential area of
Bosch ensures that its customers meet
technology.
Bosch’s competence and is a key pillar
Good Manufacturing Practice standards,
of its portfolio. Check weighing, sterile
ensuring smooth and safe production
For more information please contact:
filling and finishing equipment, blister
processes.
Inga Strobel
packaging, capsule filling and sealing
are at the core of its expertise. The
Phone +49 7951 402 648
} Services
application portfolio contains filling and
Bosch is a committed partner throughout
sealing for ampoules, bottles, cartridges,
the entire product lifecycle, offering
injection and infusion bottles as well as
reliable after-sales, audit, and mainte-
injection vials and pre-filled syringes.
nance services. The superior training
standard of our engineers ensures the
latest in quality service products, such
as the ­Embedded Engineers program to
[email protected]
6 | packazine News Facts & Trends
One of the challenges that impacts
The phenomenon itself is strongly con-
general product design from dosage to
our business is the ageing population.
nected to a higher life expectancy, which
usage.
The social phenomenon recognized as
is, going one step back in this process,
the “graying” of Europe, according to
related to better medication and phar-
The steadily increasing demand for self
the research of William H. Frey of the
maceuticals. Better formulas, ingredients
and home medication will challenge
Brookings Institution think tank, stems
and substances in pharmaceuticals have
both brand owners and their suppliers.
from the finding that the median age in
led to people having healthier and longer
New designs for the more convenient
Europe will increase from 37.7 years old
lives. There are also changes in the ways
use of pharmaceuticals are needed. But
in 2003 to 52.3 years old by 2050. These
that an ageing population purchases,
how will this develop in combination
figures are especially significant in terms
consumes and chooses its lifestyle.
with child resistance, dosage form or
production efficiency? Is it possible to
of the future percentage increase of
Besides product pricing, product quality
Europe‘s elderly population relative to its
or method of recycling, the consumption
design convenient packaging for elderly
workforce.
of a consumer good will become more
people, which is, at the same time, child
heavily reliant on new ways of presenting
resistant?
convenience of use. The average elderly
consumer will be the main target for
Products such as Burgopak are typical of
the consumer products industry and,
highly convenient packaging styles. They
especially the Western World, will have
support patient compliance and are child
enough money to afford a convenience
resistant at the same time. Other new
lifestyle. The drive for more “conven-
applications, such as those that combine
ience for the grey” in combination with
confectionery products (Conf-Med) with
further essential features will define
active pharmaceutical ingredients (API),
packazine | 7
Meeting the
­challenges of an
­ageing population
As one of the leading suppliers to the pharmaceutical packaging and
processing industry, we are committed to meeting future challenges
and satisfying changing market demands for our customers to help
them prosper in an increasingly competitive environment.
may represent future dosage forms and
weekly blister could be a solution for
will challenge producers to find new and
mass market applications.
working today on solutions for the next
decades. Together with our customers,
effective processing and packaging.
we develop technologies and partner-
Maybe the blister package will undergo
More than ever, experience and innova-
ships to give the “graying” of Europe a
tion are the tipping points. For research
colorful future.
a renaissance. In particular, for ap-
and production, the pharmaceutical
plications that require daily intake for a
industry relies on its suppliers and
For more information please contact:
period of weeks, such as birth control or
partners to provide consumers with the
Ulrike Probst
antibiotics, the well-proven blister still
“all-in-one package”. Such relationships
Phone +41 52 674 8053
represents state-of-the-art packaging. For
are essential for success and survival.
[email protected]
long-term medication with a standard
The scientists and engineers at Bosch
assortment of tablets and capsules, the
Packaging Technology are already
Development of the European median age
52.3 years
37.7 years
2000
2010
2020
2030
2040
2050
8 | packazine Customers & Markets Pharma and Cosmetic
1 The filling machine is integrated into the separation
wall between clean room and washing room
Delivery and loading of
the empty vials to the
compact line in the washing room
2 The FLC vial filling machine is equipped with an
automatic non destructive checkweighing system
3 Clear separation of machine operation and
checkweighing analysis with 2 panels
packazine | 9
Filling first,
packaging after
Axellia is the leading producer of fermented, anti-infective, active
pharmaceutical ingredients (API) and injectable finished products.
Looking to expand its manufacturing capacity for injectables, the
company turned to Bosch Packaging Technology for a compact
injectables filling line solution with integrated end-of-line secondary
packaging.
Fully automated filling
injectable vials, to ensure a reasonable
In order to meet its customers’ diversi-
shelf life of the finished product.
fied requirements, Axellia recently began
producing dosage forms of APIs in
Axellia ordered a complete filling line
injectables. This enables the company to
from Bosch in the summer of 2007,
offer both raw APIs as well as finished
consisting of a washing machine, sterili-
products in an injectable format.
zation tunnel, filling and sealing machine,
and an overseal capping machine. To
Axellia’s existing filling line for injecta-
meet the unique requirements of this
bles was exclusively devoted to powder
project, Bosch delivered the FLC 3080
filling, which was limited to only a few
filling and sealing machine, which
API products. To expand capacity for fin-
offers time-pressure filling, automatic
ished injectables and extend its portfolio
cleaning-in-place (CIP) and sterilizing-in-
to different API products, Axellia sought
place (SIP) systems, and an automatic
a liquid filling solution with sterile
checkweighing system.
processing and lyophilization capabilities.
1
2
Due to the unstable nature of certain API
The time-pressure filling system was
products, they must be freeze-dried into
selected instead of the traditional pump
a dry powder form, after being filled into
filling station because it is easier to
3
10 | packazine Customers & Markets Pharma and Cosmetic
1
2
validate the CIP and SIP process. There
Automated checkweighing
costs and minimizing the total cost of
are less mechanical parts in the time-
The fully automated, non-destructive
ownership.
pressure filling system compared to the
checkweighing in-process control system
pump filling system, which minimizes
ensures the best product quality control.
Uniquely for Axellia, the checkweighing
maintenance and offers an easier clean-
The filling machine runs on an eight-hour
in-process control offers a tracking
ing and sterilization process.
shift at a speed of 300 vials per minute.
system, designed by Bosch engineers
The check weighing system controls eight
in cooperation with the supplier of
The automatic CIP/SIP system offers
random samples every three minutes
the freeze driers. This tracking system
major benefits to Axellia. Firstly, it covers
and incorrect dosage amounts are
provides direct communication between
the in-line integrated sterilizing filter so
automatically rejected without process
the filling machine, the freeze driers and
there is no need to dismantle the system.
interruptions. At the same time, the
the capping machine, which ensures that
The system also complies with GMP
checkweighing system gives real-time,
incorrect vials are automatically rejected,
regulations, minimizing production times
in-process feedback to the time-pressure
even after the freeze-drying process.
and eliminating the danger of product
filling to ensure accurate dosing. This
The whole automatic process and com-
contamination.
fully automated system reduces the
munication gives Axellia further quality
necessity of having quality insurance
assurance.
engineers on site, thus reducing labor
packazine | 11
1 Axellia vial packaging line
2 Bosch horizontal cartoner
type CUC 2001
3 Carton erection system with
counter vacuum
4 Online carton printing and
verification
3
4
Whole-line integration
The CUC cartoning machine from Bosch
When Bosch delivered the complete
offers excellent accessibility. The
customized cartoning lines, Bosch has
filling line in the summer of 2008, the
servo technology, industrial PC control
provided Axellia with highly reliable
project manager at Axellia, Mr. Knud-E
systems and the ergonomic touch screen
machine quality, easier validation proc-
Andersen, was impressed with the
operating panel provide secure, reliable
esses and excellent customer service.
on-time delivery and the overall quality
and trouble-free production runs. The
The exceptional level of Bosch’s service
of the system. At the same time, he was
product insertion, from the back of the
and support has also given Axellia the
also looking for an end-of-line secondary
machine, significantly reduces mainte-
convenience of interacting with only
packaging solution to package the vials
nance time and allows easier cleaning
one supplier and makes the whole line
into cartons. As a result, Axellia again
and trouble-shooting. The encapsulation
integration and validation process easier.
turned to Bosch for a solution.
For the end-of-line packaging, Axellia
From fully automatic filling lines to
of the drive components and the slanted
As a result, Mr. Knud-E Andersen has
guards considerably reduce the time
been generous in his praise for Bosch
required for line clearance.
and said: “I have had a good experience
needed a labeling machine, a turntable,
with Bosch. We believe in Bosch, that’s
a cartoning machine, checkweigher,
The modular KWE 4000 checkweighing
stretch bander and a case packer.
system meets pharmaceutical safety
However, Axellia didn’t want to source
and cGMP requirements, as well as
these individual modules from different
offering simple operation and easy
suppliers. Bosch was able to offer a
line integration. The control cabinet
Klaus Schreiber
customized, one-stop-shopping solution
at the rear of the checkweigher and
Phone +49 7951 402 367
by sourcing the labeling machine, stretch
the operator terminal allows excellent
[email protected]
bander and case packer from outside
accessibility. Production statistics, trend
vendors and integrating them with its
curves and current weight are displayed
Ralph Pfister
why we buy it from Bosch.”
For more information please contact:
own cartoning machine and checkweigh-
on the standard screen, which can be
Phone +49 711 811 57 293
ing unit. Thus, Bosch provided Axellia
configured to show further information
[email protected]
with a complete end-of-line packaging
if required. The weight display can be
solution together with on-site installation
changed to large numbers for at-distance
and support.
reading by one single touch on the
screen.
12 | packazine Customers & Markets Pharma and Cosmetic
In the pharmaceutical industry,
the production of complexstructured active substances,
or biocatalysts, using biotechnological methods has been
increasing in significance for a
number of years.
With its many years of experience in the
production of pharmaceutical process
systems, Pharmatec, a Bosch Packaging
Technology company, offers tailormade solutions for the fermentation of
microorganisms. Pharmatec is known
throughout the pharmaceuticals industry
for its high-purity media production
systems, plus process and CIP systems.
The development of bioreactors and
their relevant upstream and downstream
processes will be increasingly pushed
forward by Pharmatec in the future.
To create the optimum environment for
live cells and bacteria, the challenge
lies in designing systems which firstly
offer conditions under which the desired
organisms can grow optimally and
secondly meet the high cGMP regulation
standards prevalent in the pharmaceuticals industry.
packazine | 13
New fermenter for multipurpose use in pilot plant stations
Fermentation system – various perspectives
The success of such a project is
dures, such as the batch or fed batch
outstanding results. The requirements
dependent on a number of technical and
process and scale-up trials, were to be
made on the fermenter were optimally
biological process details. Diverse pro-
tested. Various demands were also made
met and the Site Acceptance Test was
cess parameters, such as the pH value,
concerning CIP cleaning, continuous
also successfully completed. Commissi-
oxygen content, foam formation and tem-
sterilization capability and the tempera-
oning of the Pharmatec bioreactor was
perature control plus their time lapses,
ture control of the unit. The specialist‘s
therefore judged to be an unqualified
have to be constantly monitored and
innovations and wealth of ideas were
success. Further operation of the system
corrected throughout the entire fermen-
required to achieve this. Together with
under production conditions proceeded
tation process in case deviations arise.
the customer, the Pharmatec team deve-
to our customer‘s satisfaction.
Perfectly coordinated measurement and
loped a concept which was successively
control technology is therefore essential
implemented within seven months in
For more information please contact:
for successful cultivation. More extensive
Dresden. After commissioning and a
Sonnhild Fleischer
deviations from the specifications may
successful Factory Acceptance Test by
Phone +49 351 28 27 819
significantly impair the process and,
the customer, the system was installed
[email protected]
under certain circumstances, render an
precisely in its target location, started
entire batch useless.
up and transferred to the customer
following IQ and OQ.
Last year, a well known pharmaceutical company based near Frankfurt
The first trial for the new system was a
commissioned Pharmatec to supply a
long-term sterility test called media-run.
fermentation system to investigate long-
Following full sterilization of the system,
term cultivation involving streptomyces,
complete fermentation is undertaken
filamentous fungi, bacteria or yeasts for
with all of the media. Inoculation with
the production of natural substances or
a cultivated strain additionally took
recombinant proteins. Different proce-
place. The sterile tests were verified with
14 | packazine Customers & Markets Pharma and Cosmetic
Ultimate quality ­control
through 100 % control
Sanofi-Aventis, a leading global
Solution for small batch clinical trials
the GKF 1400 ASB 100% (automatic
pharmaceutical company, provides a
During the clinical trial phase of the drug
trouble shooting) machine, for its precise
broad range of medicines, vaccines and
development process, it is important for
and innovative filling of powders, pellets
integrated healthcare solutions.
Sanofi-Aventis R & D to provide different
and micro-tablets and liquids.
To produce oral forms of quality clinical
dosage forms to its patients. Additionally,
trial samples, the company was looking
a diverse range of dosage formats gives
Improved quality control
for a flexible capsule filling solution for
Sanofi-Aventis R & D the flexibility and
The major benefit that Sanofi-Aventis
receives from the new GKF 1400 ASB
100% machine is the high degree of
quality control. This is key for clinical
trial samples, with the correct weight
and dosage of each unit ensuring accurate results. Also, since the trial product
is very expensive and there is often no
spare product for a second batch run,
the machine needs 100 % quality control
prior to the filling process for both empty
capsules and product amounts.
a variety of product formats. Having
reactivity to supply on time with the
worked closely with Bosch Packaging
required quality medicines for clinical
Technology for many years, it ­decided
trials. In order to produce small batches
to invest in a new GKF compact
of clinical trial samples, Sanofi-Aventis
machine that offered 100 % check
required a flexible machine for a large
weighing.
­variety of capsule formats, including
­liquid capsules, powder in capsules,
pellet capsules, and even tablets in
capsules. Having worked with Bosch for
the last 20 years, the product manager,
Mr. Luc-Andre Claustres, decided to try
1 GKF 1400 ASB 100%
2 Operator setting up
the machine
3 Empty capsule control
with ejection
4 Online documentation of
product quality
1
2
packazine | 15
The GKF 1400 ASB 100% machine
Increased productivity
For more information please contact:
ensures 100 % weight control. Each
Fast changeovers and short cleaning
Thomas Ripke
capsule is weighed individually and with
times have improved the production
Phone +49 711 811 57527
high precision on the integrated control
speed. With the GKF 1400 ASB 100%
[email protected]
unit. The filling station readjusts the
filling 80,000 capsules per hour, com-
integrated weight regulation system for
pared to the 40,000 capsules per hour
pellets and powder applications. This
machines used previously, Sanofi-Aventis
ensures that the dosing weight is within
R&D is now able to manufacture a full
the required tolerance limits throughout
batch in only a few days. “It saves time
the production process. Software
while maintaining a high degree of qual-
generates a mean value and constantly
ity control,” says Luc-Andre Claustres.
compares the actual value with the
“It’s a pleasure to work with Bosch, and
target value. All dosing changes are
I am very satisfied with the quality of
documented in the production report to
the machine. From documentation, to
ensure regulatory compliance and any
risk analysis, functional analysis, and
capsules outside of the tolerance range
isolation qualification, it provides an
are dependably ejected.
unprecedented level of quality which
makes the qualification and validation
process on our behalf much easier.”
3
4
16 | packazine Customers & Markets Pharma and Cosmetic
Aspirin® Effect is a convenient
­solution as it can be taken without
water. It dissolves quickly in the
mouth and has a pleasant taste
packazine | 17
RAD-10 stick pack machine
The classic Aspirin®
gets a makeover
At its plant in Bitterfeld, Germany, Bayer HealthCare AG produces Aspirin® for a number of applications
and in various dosages. In order to extend production capacity for its Aspirin® Effect product, the installation of a highly efficient packaging system from Bosch Packaging Technology is scheduled for 2009. This
system solution provided by Sigpack Systems in Beringen (Switzerland) and Bosch Packaging Technology
in Waiblingen (Germany) will achieve output levels of 1000 Stick Packs and 100 cartons per minute.
New form and packaging style
quick and safe emptying of the package.
­having to be taken into consideration
Still a registered trademark in over 80
Aspirin® Effect is sold in award-winning
was the fact that Aspirin® Effect is a
countries, Aspirin® has been around for
folding cartons, used exclusively by Bayer
highly moisture-sensitive product and
over a century and is universally known
and containing 10 or 20 stick packs.
demands high impermeability levels for
in its tablet form. The introduction of
its primary packaging.
Aspirin® Effect has seen the classic
The project
tablet become available in a granulated
Ever since its launch in 2004, Aspirin®
To ensure optimum performance of the
form that is taken without the need to
Effect has enjoyed increasing sales.
entire line, it is vital to provide highly
dissolve in water and comes packaged in
­Following large increases in demand, a
efficient interfaces between primary
stick packs. The stick pack itself has an
new packaging line was introduced in
packaging, transportation/grouping and
incision, which makes it easy and safe to
2008.
secondary packaging. A “one-stop shop-
tear open. To guarantee optimal access
ping” system is the ideal solution and, in
to the product, the longitudinal seam is
Apart from a compact design and high
this respect, Bosch has full responsibility
positioned at the edge, which results in
output levels, Bayer‘s priorities were
for project handling and guarantees the
an enlarged opening cross-section. This
adherence to project schedules and,
efficiency of the system.
ensures not just easy opening but also
above all, technological safety. Also
18 | packazine Customers & Markets Pharma and Cosmetic
Working principle
stick pack system
RAD10 / CUT120
The equipment
is used. Achieving 100 cycles per minute,
Bayer and Bosch PA project teams, and
The packaging system consists of the
stacks of five stick packs and an informa-
following a tight production schedule,
10-track Stick-Pack-RAD-10, which is a
tion leaflet are inserted into the carton,
another packaging system by Bosch
transportation and grouping unit, and
which is then sealed with hot glue.
Packaging Technology will be ready to be
a horizontal cartoning machine, the
This tailor-made CUT for gable cartons
put into operation.
CUT-120.
exemplifies Bosch‘s customer-specific
approach to engineering.
For more information please contact:
a tipping filler, which achieves output
Following the validation process, produc-
Phone + 41 52 674 89 28
levels of 1000 stick packs per minute.
tion of the RAD-10 / CUT-120 Stick Pack
[email protected]
The RA Stick Pack machine is fitted with
Holger Botsch
This dosage technology, used primarily
system will start, for eventual delivery
for free-flowing products, offers highly
to the various sales regions. Thanks to
accurate dosing, careful product han-
the close cooperation and partnership of
dling and excellent accessibility.
Stick pack transportation, grouping
and stacking are areas in which Bosch‘s
experience with handling fast-moving
consumer goods and stick packs comes
to the fore. All interfaces are designed
with efficiency and safety in mind. For
handling the special Aspirin® gable
carton, a variation of the well-proven
intermittent CUT-120 cartoning machine
Cartoning machine CUT120