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packazinePharma · Issue 2010

Small Doses | Clinical Trial and Pilot Drug Production Lines3M Espe | High-Performance Filling LineCrailsheimer Pharmatag 2010 | An Inside Look at Sterile Filling

2 | packazine Table of Contents | Editorial

www.boschpackaging.com [email protected]

News

Facts & Trends04 In Small Doses | Flexibility for Clinical Trial and Pilot Drug Production Lines

Customers & Markets

Pharma & Cosmetic06 Rentschler | Pharmatec Advances Downstream Process Development (DSP) in Biotech Production

08 3M Espe | Precision Landing High-Performance Filling Line

10 Oncotec | A Symbiosis Filling and Isolator Technology for Ready-to-Use Syringes

12 Sanofi-Aventis | Increased Demand for Liquids in Hard Capsules

14 Excella | Containment Technology for Processing Highly Potent Substances

16 GlaxoSmithKline | Single-Use Dosing Systems are the Trend

18 The Ritedose Corporation | Flexible Packaging System for Blow-Fill-Seal Ampoules

Events

20 Crailsheimer Pharmatag 2010 | An Inside Look at Sterile Filling

22 Events Pharma 2010

CoverAn inside look at sterile filling

08 10 14

Table of Contents

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Dear Readers

For decades, our customers have relied on Bosch‘s high quality standards and proven technology. This is bound to be one of the reasons why, despite the difficult

market environment in 2009, our Pharma division managed to surpass order levels achieved in our record year of 2008 – and why we were able to end the fiscal year with a profit. We were particularly successful in the Asian market. More and more customers from the emerging markets are putting their trust in Bosch. All over the world, Bosch is a competent and reliable partner, even for demanding and long-term projects. We deliver what we promise. This self-image is also reflected in our new advertising campaign and its key message, „Packaged as prom-ised“. The message is underlined by concrete performance

promises to our customers in the Pharma sector.Irrespective of the current phase of the economic cycle, the pharmaceutical industry is showing a clear trend towards higher cost efficiency. Manufacturers are faced with increasing quality and safety requirements and therefore need full transparency regarding costs, including the operating costs of an installation. A full costing should also contain a calculation of efficiency increases over the life cycle of a line. There is more on this subject in the current magazine, as well as information on a targeted service management system designed to improve your Overall Equipment Effectiveness (OEE). We are now using our OEE calculation for all industries, from food to cosmetics and pharma. In the current issue, we also show how single-use systems can improve flexibility and minimize product loss.I hope you enjoy this latest edition of packazine. We are also present at a number of trade shows, giving you a chance to experience our pharma competence for yourself. We are looking forward to meeting you and exchanging views.

Sincerely,

Friedbert Klefenz

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Friedbert KlefenzPresident

Bosch Packaging Technology

Editorial

In Small DosesFlexibility for Clinical Trial and Pilot Drug Production Lines

4 | packazine News Facts & Trends

Despite the current economic crisis, the drug development pipeline is still quite robust. There are 9,605 drugs being de-veloped in 2009 according to the Pharma R&D Annual Review1 published in May 2009. This is a plus of 2,400 compared to 2005 and almost twice as much as in 2000. Clinical trials are a critical compo-nent of the drug development process, determining which drugs will be taken to market and generate revenue to compen-sate for the costly R&D cycle.

Due to smaller production volumes, lines used to produce drugs for clinical trial operations have always had distinct needs in terms of processing equipment.

Additionally, a number of industry trends are changing the drug development land-scape, and these changes are having im-portant effects on clinical trial and pilot drug production.

New Players, New Drugs, New DemandsDrug R&D activities have traditionally been dominated by large multinational pharmaceutical companies - Big Pharma. Now the rising number of mid-size bio-tech and biopharmaceutical companies moving projects into clinical trials is af-fecting equipment demands.

While established players typically have existing clinical trial lines up and running,

this is not the case for new entrants, who, as an alternative to building their own lines, often outsource operations to clinical research organisations (CROs). This is just one reason why the global CRO market is expected to grow 14 % per year during the next three years, making contract research a 35 billion USD industry by 2013, according to a re-cent report from Business Insights2. This growth has driven the need for new and improved filling and packaging machinery with increased flexibility.

Another change in drug development is the growth in production of injectable drugs, a market which is forecast to

packazine | 5

reach 12.6 billion USD by 20103, with growth in the biogenetic, oncology and vaccine segments expected to be espe-cially strong. Biopharmaceuticals in par-ticular are experiencing continuous growth, with a steady stream of products in the pipeline as well as several recent com-mercialisation successes. With regard to cancer treatment, 28 oncology drugs were approved in the EMEA (Europe, Middle East and Africa) region from 2005 to 2008 compared to 20 drugs between 1995 and 19994. More focus is being paid to vaccines as well to address chal-lenges in the area of infectious disease.5 Lastly, another trend greatly affecting the face of clinical trials is the move away from blockbuster drugs towards person-alized medicine, or pharmacogenomics.

These trends are combining to change equipment needs for clinical trial pro-duction lines, as processing these types of drugs requires different sterile filling and finishing equipment than traditional drugs.

More Flexibility One of the most prevalent demands in response to the abovementioned trends is the need for highly flexible machinery. CROs need equipment that can handle production of a variety of drugs to sup-port multiple clinical trial operations, while personalized medicine and biotech drugs call for lower volume production runs.

With smaller batch sizes of 10,000 to 20,000 vials, manufacturers can no lon-ger dedicate an entire filling line to one batch. Filling systems need to be used for multiple batches to maximize asset utilisation. Now, manufacturers and CROs need machinery that is able to fill multiple products with short startup times to increase efficiency. Flexible pro-cessing equipment also allows manufac-turers to easily accommodate the han-dling of various components, including different sizes of stoppers, caps and vi-als, as well as to easily changeover be-tween batches. Additionally, manufactur-

ers are also requiring modular machinery, allowing them to easily integrate new equipment into existing lines.

For more information please contact:

Inga Strobel

Phone +49 7951 402-648

[email protected]

1 http://www.pharmaprojects.com/therapy_analysis/annual-review-2009.htm

2 www.globalbusinessinsights.com/content/rbcr0015t.pdf

3 http://www.in-pharmatechnologist.com/Materials-Formulation/Implantable-injectable-drug-delivery-market-set-to-hit-12.6bn-by-2010

4 Development of Oncology Products. http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/article/articleDetail.jsp?id=605964

5 http://www.fiercevaccines.com/story/vaccine-market-trends-2009-predictions/2009-01-29#ixzz0Qicz0GTK

6 | packazine Customers & Markets Pharma and Cosmetic

In recent years, the market for biophar-maceutical drugs has boasted an average annual growth rate of 18 % and is there-fore by far the fastest-growing medication market. For 2010, sales of 100 billion USD are forecasted.1 Such increases have triggered a growing demand for adequate production capacity.

Rentschler Biotechnologie, based in Lau-pheim, Germany, has been developing and producing biopharmaceuticals for clinical studies and market supply for over 30 years. The company‘s portfolio includes development and GMP produc-tion of protein drugs from cell cultures in fermenters or stirred reactors. For years, Rentschler has been continuously invest-ing in new machinery, achieving a six-fold increase in its production capacity, and it now has nine independent GMP produc-tion lines with operating volumes between 30 and 2,500 liters.

Extensive ConsignmentIn the course of this capacity increase, Pharmatec, a Bosch Packaging Technol-ogy company, was commissioned with the planning and realization of a buffer store and tank facilities as DSP functions. The remit included detailed engineering, assembly at Pharmatec’s Dresden plant with acceptance inspection by the cus-tomer, on-site assembly and commission-ing, as well as joint installation and oper-ational qualification of the facility with the customer.The buffer store has four stationary tank facilities for the provision of buffers in cooled bags and a bag filling station. The buffer store has to accommodate buffer solutions with increased corrosivity, which is why special materials like high-alloy steel and synthetics were used dur-ing production.

Fully AutomatedThe installation is operated from three

operating stations secured by access rights, which are arranged in such a way that the operator has a full view of the entire installation at all times. Validated, automated programs ensure complete process control. Using external CIP facili-ties, all installations are automatically cleaned and sanitized with pure steam. More comprehensive tasks like batch log-ging, recipe management and audit trails in accordance with 21 CFR 11 regula-tions can be performed via dedicated PCs for process operation and control.

Comprehensive Project ManagementPharmatec‘s installations have now been in operation for two years, to Rentschler’s full satisfaction. Aside from adherence to schedules and budgets, Rentschler is very keen to receive extensive and comprehen-sive support over the duration of a proj-ect. Thanks to the close integration of process technology, construction and automation, combined with a high quality

Pharmatec Advances Downstream Process Development (DSP) in Biotech Production

21

1 Buffer- and NaOH distribution system

2 Tank 1,500 l, material polypro-pylene for corrosive buffer solutions

3 NaOH tank 1,500 l, material stainless steel 1.4404

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standard of manufacturing, Rentschler was able to benefit from Pharmatec‘s expertise as a competent partner to the pharmaceutical industry.

With the new Pharmatec facilities, Rent-schler is in a position to make highly suc-cessful and economic advances, in terms of DSP, in the area of biotechnological production. On-site assembly of the entire installation in Pharmatec’s Dres-den plant, successful commissioning and a Factory Acceptance Test in the pres-ence of project managers meant that Pharmatec played a key part in increas-ing planning reliability for Rentschler, as well as effectively reducing assembly and commissioning times.


Mike Müller

Phone +7 499 176 9258

[email protected]

1 http://www.igbce.de/portal/site/igbce/rote_biotechnologie/ 3


Based in Seefeld, Germany, 3M Espe is one of the leading global

suppliers of dental local anesthetics. To increase their production

capacity, the dental specialists from Seefeld, Germany, decided on

a completely new, high-performance filling line from Bosch.

Precision Landing at 3M Espe

Top Performance All AroundThe demand for local anesthetics had to continue to be met during the removal of the old filling line and the assembly of the new one. 3M Espe therefore started three-shift operations on the existing line. „Without this massive effort by our employees, this project would have failed,“ said Antonius Dirix, project man-ager at 3M Espe. The strict time frame was also a challenge for Bosch, but thanks to excellent planning, perfect communication between the responsible parties on both sides, and last but not least due to Bosch‘s expertise, „it all went like clockwork,“ as Antonius Dirix observed.

Competent Support from the StartEven before any contracts were signed, 3M Espe became satisfied with the qual-ity and efficiency of the equipment, as well as Bosch‘s know-how. As Antonius Dirix recalls, „During these important pilot tests, competent advisors and rele-vant equipment were available to us at all times. This meant that we had the opportunity to discuss important techni-cal issues during the preliminary stages.“

Doubling the CapacityThe new line consists of an RRU washing machine with a siliconization station, an HQL sterilization tunnel, and at its heart – an MLD filling and closing

machine. The new line enables produc-tion volumes to be doubled, which represents an enormous gain in perfor-mance. It also makes day-to-day produc-tion a lot easier due to its low mainte-nance requirements, which substantially contributes to improved safety and higher product quality.


Oliver Ullmann

Phone +49 7951 402-827

[email protected]

1 Efficient and flexible washing machine RRU 3123

2 Optimization of utilities thru use of the innovative siliconization station RRU 3123

3 High output MLD 5120 filling and sealing machine for cartridges

1

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Packazine interviewed Dr. Klippe, Divisional Director at 3M Espe

„Dr. Klippe, what were the principal reasons behind this new investment?“„With the existing line, we had quite sim-ply reached our capacity limit. We were also targeting new markets in Eastern Europe, Asia and Latin America.“

„How does this investment rank in 3M Espe‘s company history?“„This is one of our biggest investments of the past 20 years and represents a mile-stone in the company‘s history.“

„Why did 3M Espe decide on a partner-ship with Bosch?“„We realized very soon that Bosch was the only choice for a dedicated project like this. Naturally, we looked at alternatives but – if you pardon the comparison – you can only win a Formula 1 race if you not

only have the best driver but also the best car and the best team in the pit.“

„When the new line was installed you celebrated its inauguration. Was this a unique event just for this project?“„No, it is part of our corporate culture at 3M Espe that we invite our associates to celebrate successful projects. And for this project in particular, 3M Espe‘s suc-cess was largely due to the efforts of its workforce. Without their dedication we would have failed. It was still a very spe-cial event and, with over 100 guests, somewhat larger than usual.“

„Why would you recommend Bosch as a technology partner?“„First, would be the technical superiority of the equipment that Bosch produces. Additionally, there is Bosch’s ability to successfully complete extremely time-critical and complex projects. With

Bosch we feel, and always have felt, that what is done for us, the customer, is never any less than the best.“

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3

1/2 Isolator line for fully automated filling of cytotoxics in presteri-lized nested syringes

3 ATO: reliable tub opening with minimal particle generation

1 2


Oncotec invests in state-of-the-art filling and isolator technology

for ready-to-use syringes.

A Symbiosis - Core Competence and Cutting Edge Technology

Proven Pharma Industry Partner Oncotec Pharma Produktion, based in Dessau-Rosslau, Germany, is an industry partner valued by pharmaceutical com-panies around the world for the manu-facture and development of aseptically produced cytostatica. Oncotec has state-of-the-art production facilities with isolator protection and offers its custom-ers full service along the entire produc-tion chain, from development to market launch and commercial production.

Expanding Ready-to-Use Syringe Production Capacity Oncotec is currently expanding its pro-duction capacity for the manufacture of ready-to-use syringes for the global marketing of a highly potent anti-rheuma-toid drug, with an active cytostatic ingre-dient, as well as other cytostatic prod-ucts. Cytostatica inhibit cell growth and

are used predominantly in the treatment of tumors and autoimmune diseases. The production of these highly toxic and delicate pharmaceuticals presents spe-cific challenges, which Oncotec is meet-ing with state-of-the-art technology.

Ergonomic and Flexible Ready-to-Use Syringe Line with Isolator Oncotec‘s new line, which will be ready for production in mid 2010, processes pre-sterilized, ready-to-use glass syringes and consists of an ABO bag opener, an ATO tub opener and the FXS filling and closing machine, which is fitted with a customized Bosch isolator. Both the ABO and ATO ensure the fully automated opening of the sterilized bags and tubs, which provide speed and precision that would not be possible with manual operation. This contributes significantly to increased product quality and higher

efficiency. The FXS filling and closing machine uses a revolutionary transport system to fill and seal the syringes with complete safety and accuracy. A number of additional features, such as 100 % in-process control and special solutions for air handling, provide extra safety during the production process and also help to minimize waste.


Klaus Ullherr

Phone +49 7951 402-517

[email protected]

3

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Packazine interviewed Jürgen Powollik, Head of Production at Oncotec

„Mr Powollik, Oncotec‘s new line is fitted with state-of-the-art isolator technology from Bosch. How important is this tech-nology?“„I am convinced that isolators have clear advantages over clean room filling. There is an enormous potential for sav-ings, which is still not realized by many pharmaceutical producers. In the asep-tic filling of highly potent drugs, an iso-lator simplifies operation of the entire installation and provides optimal opera-tor safety, as well as higher product quality, especially if it comes from the same supplier and works in perfect

harmony with the filling and closing machine.“

„...which is indeed the case for the current project. Aside from the isolator, what convinced you to go for the Bosch solution?“„The entire concept for ready-to-use syringes in the tub: transport, handling and opening of sterile bags and tubs, as well as the air handling at critical locations within the isolator. I saw the installation and I immediately knew: this is it. Bosch also set a very high standard for the qualification.“

„Why would you recommend Bosch?“„Key factors are technological superiority, professional project management and

the ready availability of experts providing a level of assurance, which customers want from their machine supplier, especially for more complex projects.“

Positive handling of presterilized nested syringes

Innovative liquid filling pump enables to fill a wide range

of products


Leading SupplierBosch Packaging Technology managed to recognize this trend early on, evaluated the market accordingly and, with its GKF capsule filling machines, positioned itself as the leading supplier in this segment. Thanks to the new liquid filling pump, GKF machines are now able to fill a wide range of products. This includes pro-ducts with a critical melting point range, high or low viscosity, and also product combinations.Sanofi-Aventis, based in France, is one of the world’s leading pharmaceutical com-

panies and has invested in five high-per-formance GKF capsule filling machines from Bosch over the past three years. The investment was made to support an increasing demand for the Essentiale liver preparation. In China, Sanofi-Aventis operates pro-duction sites in Beijing, Hangzhou and Shenzhen, with the Essentiale liver pre-paration being produced at its Beijing fa-cility. As a result of its previous positive experiences, it has now decided to ex-tend its use of the proven GKF series into the Chinese market.

A Customized Solution The GKF 2500L project for Sanofi-Aventis was a major challenge for Bosch. The ob-jective of the pharmaceutical company was to achieve high output levels on a single machine, which resulted in a num-ber of requirements. Bosch engineers were able to use proven concepts of the GKF series but needed to develop a spe-cial filling pump for a product, which was not just difficult to fill but also tem-perature-sensitive. The pump also had to be able to maintain a constant filling weight. An additional problem was that

Sanofi-Aventis Investment Shows Increased Demand for Liquids in Hard Capsules

Liquids in hard capsules have secured a substantial market share

over the past few years, with an increasing number of pharmaceutical

companies turning to this dosage form.

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the timeframe for developing the new pump was quite short.

Key to SuccessThe key to success was the experience and product know-how gained from the development of earlier GKF capsule fil-ling machines. A constant exchange of in-formation between Sanofi-Aventis and Bosch was another contributing factor to the successful realization of this ambi-tious project.The enormous distance between Bosch‘s German location and the production site

in Beijing was obviously a critical factor. However, the geographical distance was offset by training and the early involve-ment of the Chinese engineers in the project. Due to the global presence of Bosch engineers, the project proceeded without any language or cultural barriers. Bosch is also able to handle fast and fle-xible on-site servicing and this was ano-ther key factor for Sanofi-Aventis in its decision to award this project to Bosch.

The project was a huge success for both companies. Tom Li, Deputy Production

Manager, and Cai Yimin, Maintenance Supervisor of Sanofi-Aventis are deligh-ted with their new high-performance ma-chine and the extremely accurate and consistent filling results. Sanofi-Aventis was won over by Bosch Packaging Technology‘s ability to provide professio-nal project management and on-schedule completion even over long distances.


Felix Nink

Phone +49 711 811-57526

[email protected]


Containment Technology from Bosch for Processing Highly Potent Substances at Excella

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There is a continuing increased demand for highly potent medicinal products, which require special handling and reliable containment technology during development and processing. With its 25 years‘ experience, Excella is a proven specialist in handling such highly potent substances for the pharmaceutical sector. As part of the Fareva Group, it is one of the world‘s leading specialist suppliers in this area, offering develop-ment and process know-how and provid-ing guidance to its customers, from pre-formulation and clinical testing to commercial production.

One Step AheadWhen processing highly potent pharma-ceutical substances, requirements not only include top-quality equipment, but also the need for experience and special-ist knowledge with regards to the processes and containment infrastruc-ture, as well as highly qualified person-nel. As a result, Excella has acquired Bosch Packaging Technology‘s HiProTect capsule filler, the latest innovation in containment technology, which offers integrated 100 % control. The GKF HiProTect has provided Excella with innovative process technology for time- efficient development, as well as a safe

production environment during the com-mercial phase.

An Integrated SolutionBosch, a technology leader in packaging and filling systems for pharmaceutical products, developed the GKF HiProTect capsule filling system as a comprehen-sive containment solution for the indus-try‘s sophisticated requirements. At the heart of the capsule filler is a fully inter-nal isolation system. A major advantage of the GKF HiProTect, and of great importance to Excella, is its high level of flexibility for processing a broad variety of materials. These include powders, pellets, tablets, liquids and even combination formats. The machine has a no-cap/no-fill function, which avoids product contamination and dust damage, keeps the production area clean and supports cleaning operations. A fully automated wash-in-place (WIP) or clean-in-place (CIP) system ensures high oper-ator and process safety and also allows fast product changeovers.

For maintenance operations and inter-ventions, the installation is easily acces-sible from all sides via glove ports. Gross and net weighing of capsules guarantees the quality of the end product. The

weighing units will even identify minimal deviations from the preset filling quantity and can adjust the filler station accord-ingly. This avoids continuous failures, downtime and additional costs. Bernd Mümmler, Excella‘s production manager, has been impressed by the HiProTect: „We are fully convinced by the logical overall concept offered by Bosch with its HiProTect. The integrated weight control ensures the highest quality standards for the process and for our customers in the pharma sector.“

Safety for the FutureThe fully-integrated weighing operation, a flexible adaptation of various filling stations and the automatic cleaning pro-cess combine for an uncompromising containment concept and account for the GKF HiProTect‘s unique position within the marketplace. As a result, Excella‘s partnership with Bosch offers pharma companies a low-risk develop-ment phase with a seamless transition to the commercial processing of highly potent pharmaceutical substances.


Felix Nink

Phone +49 711 811-57526

[email protected]


GlaxoSmithKline (GSK) is a global leader in research-oriented healthcare, commit-ted to the development of innovative medicinal drugs. The company‘s objective is to improve people‘s quality of life by enabling them to lead more active, longer and healthier lives. The GSK production facility in Barnard Castle, UK, employs

around 1,000 workers and plays a key role in introducing new GSK products to the market. It manu factures a variety of drugs, including liquid pharmaceuticals in vials and syringes, as well as antibiotics and topically administered products such as Zovirax. The Barnard Castle site also plays a key role in the launch of new products

for GSK. In late 2008, GSK was looking for a filling solution for a new product. The main concern was to avoid any cross- contamination between various products and it found an intelligent solution in the shape of Bosch‘s single-use dosing system.

GlaxoSmithKline Relies on Bosch Peristaltic Pumps

Single-Use Dosing Systems Are the Trend

Open pump head allows easy replacement of hoses

1 Replacement of a pre-assembled single- use filling needle

2 Pump trolley FDM 1060

3 Stainless steel single- use filling needle

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Ideal for Biotech ProductsSingle-use dosing systems have distinct advantages, especially for biopharma products and in processing highly active substances: absolutely no cleaning requirements for product-contact parts, minimal risk of cross-contamination, lower investment costs and shorter develop-ment periods. To further advance this area, Bosch developed the PreVAS concept (PreValidated, PreAssembled, PreSterilized) for single-use dosing systems, in which all product-contact parts (hoses, product bags, filling needles) are delivered pre-assembled and sterilized. Integral parts of this system are Bosch peristaltic pumps.

More FlexibilityGSK decided on the Bosch single-use dosing system with peristaltic pumps, as

a customized, mobile unit. The peristaltic pumps are mounted on a movable trolley and are positioned next to the filling line when required. At the end of production, the product-contact parts are disposed of. Normally, single-use dosing systems use molded plastic needles. However, GSK uses stainless steel filling needles with a plastic coating. These special needles, produced by Bosch, ensure a much higher reproducibility of filling volumes than plastic needles.The performance range of the existing filling machine is also considerably extended by retrofitting peristaltic pumps. GSK can now choose between the installed time-pressure dosing system and the peristaltic pumps on the movable trolley. This way, new products can be prepared for production more quickly and with considerably less effort.

A Proven PartnershipGSK and Bosch have maintained a close partnership over many years. This was also a decisive factor in the successful outcome of this project. GSK project manager Graeme Wilson said: „The level of dosing accuracy of the peristaltic pumps is quite impressive. We were able to prove this over various production batches and I was highly satisfied with the handling by Bosch. Trolley design, as well as commissioning and qualifica-tion on site, were completed within a very short time.“


Ulrich Frank

Phone +49 7951 402-7969

[email protected]

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1 Packaging solutions for inhalation drugs2 Hermetically tight packages with user

instructions3 Print data verification on the film4 Format flexibility through different

carton sizes


Inhalation Solution for Blow-Fill-Seal Ampoules

Expanding a Flexible Packaging System

The Ritedose Corporation (TRC) located in South Carolina, USA, is one of the leading blow-fill-seal (BFS) contract manufacturers and has expanded the capacity of its packaging system several times for the primary and secondary packaging of inhalation solution prod-ucts. In order to further increase its capacity, TRC put its trust in tried-and-tested Sigpack Systems packaging lines, which have provided the company with highly flexible, high-output packaging systems.

Future-Proof ConceptTRC operates its packaging lines 24 hours per day, seven days a week. The packaging lines are very flexible with multi-format capability. As an experi-enced and dependable system provider, Sigpack Systems designed the original system which could potentially have

additional packaging legs to further increase TRC’s packaging capacity.In explaining the concept behind the sys-tem, Jörg Kleiner, Sigpack Systems head of Pharma sales said, “When placing the original order, the customer emphasized the importance of having a system that could be extended in a flexible manner at a later date, and which would be adaptable to changing market needs. Even when adding this extension, we have allowed for the option of incorpo-rating one more packaging leg in the future. TRC had many reasons for decid-ing in favor of Sigpack Systems when placing the order. One of them was cer-tainly our expertise in designing and implementing complex, multistage, flexi-ble-format packaging systems. TRC was also convinced by the technology used and their satisfactory experience with the previously installed equipment in

their facility. Sigpack equipment can be relied upon to deliver the performance customers want – and TRC knows that.”

Speed and PrecisionThe TRC packaging system receives the vial cards in bulk containers. A vibratory feeding device unscrambles the vial cards and feeds the products to a double Delta LDF robot cell, which recognizes the vials using a vision system and places them, correctly aligned, into the infeed chain of a pillow pack machine. The pre-cision of the robotic units meets the challenging task of stacking these prod-ucts at a high speed into the continu-ously running lug chain of the wrapper. The use of the Delta robot technology keeps format changeover very easy for the operator, by just selecting the new recipe on the HMI and uploading the data by pressing a button.

1 2

The modular Sigpack Systems toploader platform provides the base for almost endless variations. The TBLi case packer and the TTL toploader only differ in the combination and arrangement of their modules. For example, the case packer does not always require a sophisticated grouping device as this func-tion can also be carried out by a more straightforward transfer unit. In addition to its reliability in continuous use, the entire Sigpack Systems toploader family is notable for its rapid and reproducible format changeover, without the need to change a large number of parts.

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The stacked vials are passed on to the HBL horizontal pillow pack machine. In order to achieve tight hermetic packs, the pillow pack machine is equipped with an air extractor and mechanical gus-seting. Water-cooled cover plates above the sealing unit protect the product from radiated heat. A printer then labels the pillow packs with the batch number and expiration date.

In the next stage, the finished pillow packs move on to the product grouping device of the TTL toploader. At the other side of the toploader, the cartons for

loading produced on a TTF carton erec-tor are fed in. The toploader then groups the correct number of cartons for each batch underneath the gripper, forms a stack of pillow packs (the type of stack depends on the packaging format), and loads them into the cartons. Once loaded, the cartons leave the toploader and move on to the inline closer, which folds down the dust flaps and inserts the front flap. A TBLi case packer then fin-ishes the carton packs for final shipping.


Joerg Kleiner

Phone +41 52 674-6913

[email protected]

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Crailsheimer Pharmatag 2010An Inside Look at Sterile FillingBosch Hosts Two-Day Customer Symposium

Bosch Packaging Technology welcomed industry representatives and experts to the two-day Crailsheimer Pharmatag 2010, the company’s international customer symposium on sterile filling. Participants experienced a factory tour and viewed innovative pharmaceutical processing and packaging machines in the Bosch showroom. Presentations by high-profile customers and discussion rounds provided a platform to share experiences on current trends in sterile filling, with emphasis on vials, syringes and containment technologies. The event was moderated by Dr. Georg Roessling, Senior Vice President, PDA Europe.

Over 220 pharmaceutical professionals keenly followed the keynote speech by Dr. Manfred Schubert-Zsilavecz, Vice Pre-sident, Goethe-University Frankfurt, who discussed the importance of innovative pharmaceuticals and therapy forms for quality of life improvements. He called for equally innovative production equip-ment to fulfill the resulting requirements.

Vial Filling In a workshop on vial filling, attendees highlighted that automated filling solutions are increasingly critical to strengthen production safety, reduce human error and diminish contamination. Dr. Simone Dahlmanns, Operations

Director, Hameln Pharma, used her company as an example to illustrate how Bosch technology can help with remanufacturing, lean production and operational excellence for vial and ampoule filling. In a second presentation Rainer Herbener, Technical Project Manager, CSL Behring, gave details on how the new filling and lyophilization lines by Bosch were built and installed during production. With two new lines CSL Behring now has the flexibility it needs to face future shifts in demand.

Barrier SystemsThe production of highly potent biophar-maceutical and parenteral drugs results


in a higher demand for containment technologies. A workshop led by Dr. Friedrich Haefele, Head of Biopharma Operations, Boehringer Ingelheim, and Mathias Kreher, Product Manager, Bosch, discussed the usage of barrier systems to enhance safety. As part of this work-shop the reduction of human interaction and cross-contamination were examined. Mr. Kreher stated that in the future, barrier systems will be the standard for aseptic filling.

Giorgio Salciarini, Production Manager, BSP Pharmaceuticals, illustrated how companies can safely and effectively produce highly potent drugs. He praised the success of his facility’s high contain-ment manufacturing. The fully automated Bosch line enables the company to safely and compliantly handle a range of sterile products.

Syringe Filling Due to the continuing rise in the production of biotech drugs, the general conditions of syringe filling are changing. Dr. Thomas Schoenknecht, Director Drug Product & Device Development, Amgen, and Klaus Ullherr, Product Manager, Bosch, explained that ready-to-use syrin-ges are growing in popularity as they are suitable for production in small batches. They also highlighted increasing demand

for combination products, such as auto and needleless injectors. The handling of pre-sterilized vials and cartridges were also discussed in depth.In a presentation, Dr. Bernd Sennhenn, Head Maintenance and Engineering, Ab-bott, explained the benefits that can be achieved by integrating a modern syringe filling line from Bosch at a pilot plant. According to Dr. Sennhenn, a compact machinery layout and dosing flexibility were crucial, as was the automation of several important functions, including bag opening.

Foresight In the panel discussion, moderated by Dr. Georg Roessling, the consensus among participants was that the demand for tailor-made, automated solutions is growing. There is also an increasing need for flexible filling solutions to accommodate different batch sizes, to cater to continuing advancements in personalized medicine.

“We are very proud that numerous customers accepted the invitation to this year‘s Pharmatag. The feedback during and after the event was extremely positive, in particular with regard to the discussions, the interesting lecture and workshop program, the machine exhibits, and the successful evening event.” said

Kurt Stefan Klaiber, site manager of Bosch Crailsheim.

„In the past Bosch delivered machines, today Bosch develops and delivers production line-concepts and should tomorrow develop entire pharmaceutical processes.“ Udo J. Vetter, Vetter Pharma Head of the Supervisory Board


Inga Strobel

Phone +49 7951 402-648

[email protected]

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