pharma · issue 01/2009 - syntegon japan · 2019-08-19 · a dry powder form, after being filled...

packazinePHARMA · Issue 01/2009

Axellia | Filling first, packaging afterSanofi-Aventis | Ultimate quality controlBayer | Turnkey system solution for Aspirin® Effect

2 | packazine Table of contents | Editorial

www.boschpackaging.com [email protected]

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

06 08

Tableof contents

packazine | 3

Dear Readers,

A look back on last year shows that we were extremely successful. In 2008, our as-

sociates 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.

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 owner-

ship.

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-decontamina-

tions 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

12 16

Friedbert Klefenz

President

Bosch Packaging

Technology

Editorial

4 | packazine News Facts & Trends

Under the Bosch umbrella, the pharma-

ceutical businesses comprise of product

brands such as Moeller & Devicon,

Pharmatec, SBM Schoeller-Bleckmann

Medizintechnik, Sigpack Systems and Va-

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

industry. The interdisciplinary approach

of Bosch directs an international

network of engineers to optimize project

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.

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

knowledge in optimizing production processes and safety, enhancing

efficiency and reducing total lifetime costs.

Interdisciplinary knowledge exchange for pharmaceutical packaging and processing

Bosch Packaging Technology

Moeller & Devicon | Pharmatec |

SBM Schoeller-Bleckmann Medizin-

technik | Sigpack Systems | Valicare

Visit us in Hall 3.1, Stand F2 – J11.

For more information please visit www.boschpackaging.com

12th May 2009, 3.30 pm, Konstant Forum:

Influence of Humidity, Concentration and Condensation on Efficacy and Penetration in

Bio-Decontamination Processes Applying H2O2 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

14th May 2009, 10.30 am, Illusion 3, CMF:

Image Processing as Useful Technology in the High-Throughput Analysis of Formulations

and Coatings

Come and experience Bosch at the ACHEMA convention. Visit our lectures.

packazine | 5

} Process Technology

Bosch’s process technology expertise

combines aseptic and sterile processing,

which includes equipment, container and

product sterilization, isolator systems

and restricted access barrier systems

(RABS). Equipment for clean facilities

that produce, store and distribute

sterile and aseptic products complete

the portfolio to serve customers from

biopharmaceutical to medical device

industries. Furthermore Bosch offers

production and forming lines for medi-

cated confectionery and other formable

masses.

} Primary Packaging

Primary packaging is an essential area of

Bosch’s competence and is a key pillar

of its portfolio. Check weighing, sterile

filling and finishing equipment, blister

packaging, capsule filling and sealing

are at the core of its expertise. The

application portfolio contains filling and

sealing for ampoules, bottles, cartridges,

injection and infusion bottles as well as

injection vials and pre-filled syringes.

} Secondary Packaging

For secondary packaging, Bosch offers

cartoning and toploading systems,

flow wrapping machines with hermetic

sealing, and end-of-line packaging equip-

ment. This product range enables custo-

mers to work with Bosch from primary

packaging to end-of-line applications.

} Qualification

Part of Bosch’s full service offering also

includes qualification and validation

services for laboratory equipment as

well as manufacturing processes for

pharmaceutical, biopharmaceutical

and life science applications. To meet

international qualification requirements,

Bosch ensures that its customers meet

Good Manufacturing Practice standards,

ensuring smooth and safe production

processes.

} Services

Bosch is a committed partner throughout

the entire product lifecycle, offering

reliable after-sales, audit, and mainte-

nance services. The superior training

standard of our engineers ensures the

latest in quality service products, such

as the Embedded Engineers program to

maximize the availability of production

equipment. Bosch Packaging Services

is determined to meet future market

requirements to reduce total cost of

ownership and protect capital equipment

investments.

Our Promise

Bosch Packaging Technology’s promise

is to continue its leadership role in the

pharmaceutical industry with innovative,

reliable and economical solutions.

Bosch’s overall objective and driving

force is enabling customers to get one-

stop-solutions and create sustainable

business growth through state-of-the-art

services, processing and packaging

technology.

For more information please contact:

Inga Strobel

Phone +49 7951 402 648

[email protected]

6 | packazine News Facts & Trends

One of the challenges that impacts

our business is the ageing population.

The social phenomenon recognized as

the “graying” of Europe, according to

the research of William H. Frey of the

Brookings Institution think tank, stems

from the finding that the median age in

Europe will increase from 37.7 years old

in 2003 to 52.3 years old by 2050. These

figures are especially significant in terms

of the future percentage increase of

Europe‘s elderly population relative to its

workforce.

The phenomenon itself is strongly con-

nected to a higher life expectancy, which

is, going one step back in this process,

related to better medication and phar-

maceuticals. Better formulas, ingredients

and substances in pharmaceuticals have

led to people having healthier and longer

lives. There are also changes in the ways

that an ageing population purchases,

consumes and chooses its lifestyle.

Besides product pricing, product quality

or method of recycling, the consumption

of a consumer good will become more

heavily reliant on new ways of presenting

convenience of use. The average elderly

consumer will be the main target for

the consumer products industry and,

especially the Western World, will have

enough money to afford a convenience

lifestyle. The drive for more “conven-

ience for the grey” in combination with

further essential features will define

general product design from dosage to

usage.

The steadily increasing demand for self

and home medication will challenge

both brand owners and their suppliers.

New designs for the more convenient

use of pharmaceuticals are needed. But

how will this develop in combination

with child resistance, dosage form or

production efficiency? Is it possible to

design convenient packaging for elderly

people, which is, at the same time, child

resistant?

Products such as Burgopak are typical of

highly convenient packaging styles. They

support patient compliance and are child

resistant at the same time. Other new

applications, such as those that combine

confectionery products (Conf-Med) with

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

will challenge producers to find new and

effective processing and packaging.

Maybe the blister package will undergo

a renaissance. In particular, for ap-

plications that require daily intake for a

period of weeks, such as birth control or

antibiotics, the well-proven blister still

represents state-of-the-art packaging. For

long-term medication with a standard

assortment of tablets and capsules, the

weekly blister could be a solution for

mass market applications.

More than ever, experience and innova-

tion are the tipping points. For research

and production, the pharmaceutical

industry relies on its suppliers and

partners to provide consumers with the

“all-in-one package”. Such relationships

are essential for success and survival.

The scientists and engineers at Bosch

Packaging Technology are already

working today on solutions for the next

decades. Together with our customers,

we develop technologies and partner-

ships to give the “graying” of Europe a

colorful future.


Ulrike Probst

Phone +41 52 674 8053

[email protected]

2000

37.7 years

52.3 years

2010 2020 2030 2040 2050

Development of the European median age

Delivery and loading of

the empty vials to the

compact line in the wash-

ing room

1 The filling machine is integrated into the separation

wall between clean room and 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

8 | packazine Customers & Markets Pharma and Cosmetic

1 2 3

packazine | 9

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.

Filling first, packaging after

Fully automated filling

In order to meet its customers’ diversi-

fied requirements, Axellia recently began

producing dosage forms of APIs in

injectables. This enables the company to

offer both raw APIs as well as finished

products in an injectable format.

Axellia’s existing filling line for injecta-

bles was exclusively devoted to powder

filling, which was limited to only a few

API products. To expand capacity for fin-

ished injectables and extend its portfolio

to different API products, Axellia sought

a liquid filling solution with sterile

processing and lyophilization capabilities.

Due to the unstable nature of certain API

products, they must be freeze-dried into

a dry powder form, after being filled into

injectable vials, to ensure a reasonable

shelf life of the finished product.

Axellia ordered a complete filling line

from Bosch in the summer of 2007,

consisting of a washing machine, sterili-

zation tunnel, filling and sealing machine,

and an overseal capping machine. To

meet the unique requirements of this

project, Bosch delivered the FLC 3080

filling and sealing machine, which

offers time-pressure filling, automatic

cleaning-in-place (CIP) and sterilizing-in-

place (SIP) systems, and an automatic

checkweighing system.

The time-pressure filling system was

selected instead of the traditional pump

filling station because it is easier to

1 2


validate the CIP and SIP process. There

are less mechanical parts in the time-

pressure filling system compared to the

pump filling system, which minimizes

maintenance and offers an easier clean-

ing and sterilization process.

The automatic CIP/SIP system offers

major benefits to Axellia. Firstly, it covers

the in-line integrated sterilizing filter so

there is no need to dismantle the system.

The system also complies with GMP

regulations, minimizing production times

and eliminating the danger of product

contamination.

Automated checkweighing

The fully automated, non-destructive

checkweighing in-process control system

ensures the best product quality control.

The filling machine runs on an eight-hour

shift at a speed of 300 vials per minute.

The check weighing system controls eight

random samples every three minutes

and incorrect dosage amounts are

automatically rejected without process

interruptions. At the same time, the

checkweighing system gives real-time,

in-process feedback to the time-pressure

filling to ensure accurate dosing. This

fully automated system reduces the

necessity of having quality insurance

engineers on site, thus reducing labor

costs and minimizing the total cost of

ownership.

Uniquely for Axellia, the checkweighing

in-process control offers a tracking

system, designed by Bosch engineers

in cooperation with the supplier of

the freeze driers. This tracking system

provides direct communication between

the filling machine, the freeze driers and

the capping machine, which ensures that

incorrect vials are automatically rejected,

even after the freeze-drying process.

The whole automatic process and com-

munication gives Axellia further quality

assurance.

3 4

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

packazine | 11

Whole-line integration

When Bosch delivered the complete

filling line in the summer of 2008, the

project manager at Axellia, Mr. Knud-E

Andersen, was impressed with the

on-time delivery and the overall quality

of the system. At the same time, he was

also looking for an end-of-line secondary

packaging solution to package the vials

into cartons. As a result, Axellia again

turned to Bosch for a solution.

For the end-of-line packaging, Axellia

needed a labeling machine, a turntable,

a cartoning machine, checkweigher,

stretch bander and a case packer.

However, Axellia didn’t want to source

these individual modules from different

suppliers. Bosch was able to offer a

customized, one-stop-shopping solution

by sourcing the labeling machine, stretch

bander and case packer from outside

vendors and integrating them with its

own cartoning machine and checkweigh-

ing unit. Thus, Bosch provided Axellia

with a complete end-of-line packaging

solution together with on-site installation

and support.

The CUC cartoning machine from Bosch

offers excellent accessibility. The

servo technology, industrial PC control

systems and the ergonomic touch screen

operating panel provide secure, reliable

and trouble-free production runs. The

product insertion, from the back of the

machine, significantly reduces mainte-

nance time and allows easier cleaning

and trouble-shooting. The encapsulation

of the drive components and the slanted

guards considerably reduce the time

required for line clearance.

The modular KWE 4000 checkweighing

system meets pharmaceutical safety

and cGMP requirements, as well as

offering simple operation and easy

line integration. The control cabinet

at the rear of the checkweigher and

the operator terminal allows excellent

accessibility. Production statistics, trend

curves and current weight are displayed

on the standard screen, which can be

configured to show further information

if required. The weight display can be

changed to large numbers for at-distance

reading by one single touch on the

screen.

From fully automatic filling lines to

customized cartoning lines, Bosch has

provided Axellia with highly reliable

machine quality, easier validation proc-

esses and excellent customer service.

The exceptional level of Bosch’s service

and support has also given Axellia the

convenience of interacting with only

one supplier and makes the whole line

integration and validation process easier.

As a result, Mr. Knud-E Andersen has

been generous in his praise for Bosch

and said: “I have had a good experience

with Bosch. We believe in Bosch, that’s

why we buy it from Bosch.”


Klaus Schreiber

Phone +49 7951 402 367

[email protected]

Ralph Pfister

Phone +49 711 811 57 293

[email protected]


With its many years of experience in the

production of pharmaceutical process

systems, Pharmatec, a Bosch Packaging

Technology company, offers tailor-

made 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 pharmaceuti-

cals industry.

In the pharmaceutical industry,

the production of complex-

structured active substances,

or biocatalysts, using biotech-

nological methods has been

increasing in significance for a

number of years.

packazine | 13

The success of such a project is

dependent on a number of technical and

biological process details. Diverse pro-

cess parameters, such as the pH value,

oxygen content, foam formation and tem-

perature control plus their time lapses,

have to be constantly monitored and

corrected throughout the entire fermen-

tation process in case deviations arise.

Perfectly coordinated measurement and

control technology is therefore essential

for successful cultivation. More extensive

deviations from the specifications may

significantly impair the process and,

under certain circumstances, render an

entire batch useless.

Last year, a well known pharmaceu-

tical company based near Frankfurt

commissioned Pharmatec to supply a

fermentation system to investigate long-

term cultivation involving streptomyces,

filamentous fungi, bacteria or yeasts for

the production of natural substances or

recombinant proteins. Different proce-

dures, such as the batch or fed batch

process and scale-up trials, were to be

tested. Various demands were also made

concerning CIP cleaning, continuous

sterilization capability and the tempera-

ture control of the unit. The specialist‘s

innovations and wealth of ideas were

required to achieve this. Together with

the customer, the Pharmatec team deve-

loped a concept which was successively

implemented within seven months in

Dresden. After commissioning and a

successful Factory Acceptance Test by

the customer, the system was installed

precisely in its target location, started

up and transferred to the customer

following IQ and OQ.

The first trial for the new system was a

long-term sterility test called media-run.

Following full sterilization of the system,

complete fermentation is undertaken

with all of the media. Inoculation with

a cultivated strain additionally took

place. The sterile tests were verified with

outstanding results. The requirements

made on the fermenter were optimally

met and the Site Acceptance Test was

also successfully completed. Commissi-

oning of the Pharmatec bioreactor was

therefore judged to be an unqualified

success. Further operation of the system

under production conditions proceeded

to our customer‘s satisfaction.


Sonnhild Fleischer

Phone +49 351 28 27 819

[email protected]

New fermenter for multipur-pose use in pilot plant stations

Fermentation system – various perspectives

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


Sanofi-Aventis, a leading global

pharmaceutical company, provides a

broad range of medicines, vaccines and

integrated healthcare solutions.

To produce oral forms of quality clinical

trial samples, the company was looking

for a flexible capsule filling solution for

a variety of product formats. Having

worked closely with Bosch Packaging

Technology for many years, it decided

to invest in a new GKF compact

machine that offered 100 % check

weighing.

Solution for small batch clinical trials

During the clinical trial phase of the drug

development process, it is important for

Sanofi-Aventis R & D to provide different

dosage forms to its patients. Additionally,

a diverse range of dosage formats gives

Sanofi-Aventis R & D the flexibility and

reactivity to supply on time with the

required quality medicines for clinical

trials. In order to produce small batches

of clinical trial samples, Sanofi-Aventis

required a flexible machine for a large

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

the GKF 1400 ASB 100% (automatic

trouble shooting) machine, for its precise

and innovative filling of powders, pellets

and micro-tablets and liquids.

Improved quality control

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 accu-

rate 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.

Ultimate quality control through 100 % control

3 4

packazine | 15

The GKF 1400 ASB 100% machine

ensures 100 % weight control. Each

capsule is weighed individually and with

high precision on the integrated control

unit. The filling station readjusts the

integrated weight regulation system for

pellets and powder applications. This

ensures that the dosing weight is within

the required tolerance limits throughout

the production process. Software

generates a mean value and constantly

compares the actual value with the

target value. All dosing changes are

documented in the production report to

ensure regulatory compliance and any

capsules outside of the tolerance range

are dependably ejected.

Increased productivity

Fast changeovers and short cleaning

times have improved the production

speed. With the GKF 1400 ASB 100%

filling 80,000 capsules per hour, com-

pared to the 40,000 capsules per hour

machines used previously, Sanofi-Aventis

R&D is now able to manufacture a full

batch in only a few days. “It saves time

while maintaining a high degree of qual-

ity control,” says Luc-Andre Claustres.

“It’s a pleasure to work with Bosch, and

I am very satisfied with the quality of

the machine. From documentation, to

risk analysis, functional analysis, and

isolation qualification, it provides an

unprecedented level of quality which

makes the qualification and validation

process on our behalf much easier.”


Thomas Ripke

Phone +49 711 811 57527

[email protected]

Aspirin® Effect is a convenient

solution as it can be taken without

water. It dissolves quickly in the

mouth and has a pleasant taste


RAD-10 stick pack machine

packazine | 17

New form and packaging style

Still a registered trademark in over 80

countries, Aspirin® has been around for

over a century and is universally known

in its tablet form. The introduction of

Aspirin® Effect has seen the classic

tablet become available in a granulated

form that is taken without the need to

dissolve in water and comes packaged in

stick packs. The stick pack itself has an

incision, which makes it easy and safe to

tear open. To guarantee optimal access

to the product, the longitudinal seam is

positioned at the edge, which results in

an enlarged opening cross-section. This

ensures not just easy opening but also

quick and safe emptying of the package.

Aspirin® Effect is sold in award-winning

folding cartons, used exclusively by Bayer

and containing 10 or 20 stick packs.

The project

Ever since its launch in 2004, Aspirin®

Effect has enjoyed increasing sales.

Following large increases in demand, a

new packaging line was introduced in

2008.

Apart from a compact design and high

output levels, Bayer‘s priorities were

adherence to project schedules and,

above all, technological safety. Also

having to be taken into consideration

was the fact that Aspirin® Effect is a

highly moisture-sensitive product and

demands high impermeability levels for

its primary packaging.

To ensure optimum performance of the

entire line, it is vital to provide highly

efficient interfaces between primary

packaging, transportation/grouping and

secondary packaging. A “one-stop shop-

ping” system is the ideal solution and, in

this respect, Bosch has full responsibility

for project handling and guarantees the

efficiency of the system.

The classic Aspirin® gets a makeoverAt 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 installa-

tion 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.

Working principle

stick pack system

RAD10 / CUT120


The equipment

The packaging system consists of the

10-track Stick-Pack-RAD-10, which is a

transportation and grouping unit, and

a horizontal cartoning machine, the

CUT-120.

The RA Stick Pack machine is fitted with

a tipping filler, which achieves output

levels of 1000 stick packs per minute.

This dosage technology, used primarily

for free-flowing products, offers highly

accurate dosing, careful product han-

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

is used. Achieving 100 cycles per minute,

stacks of five stick packs and an informa-

tion leaflet are inserted into the carton,

which is then sealed with hot glue.

This tailor-made CUT for gable cartons

exemplifies Bosch‘s customer-specific

approach to engineering.

Following the validation process, produc-

tion of the RAD-10 / CUT-120 Stick Pack

system will start, for eventual delivery

to the various sales regions. Thanks to

the close cooperation and partnership of

Bayer and Bosch PA project teams, and

following a tight production schedule,

another packaging system by Bosch

Packaging Technology will be ready to be

put into operation.


Holger Botsch

Phone + 41 52 674 89 28

[email protected]

Cartoning machine CUT120

pharma · issue 01/2009 - syntegon japan · 2019-08-19 · a dry powder form, after being filled...

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