Pharma · Issue 2011 pack azine · Pharma · Issue 2011 azine Novartis | Facility of the Year Award...

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pack azine Pharma · Issue 2011 Novartis | Facility of the Year Award 2011 Roche | Efficient and Flexible Secondary Packaging North China Pharmaceutical Company | 10 Production Lines in 8 Months

Transcript of Pharma · Issue 2011 pack azine · Pharma · Issue 2011 azine Novartis | Facility of the Year Award...

Page 1: Pharma · Issue 2011 pack azine · Pharma · Issue 2011 azine Novartis | Facility of the Year Award 2011 Roche | Efficient and Flexible Secondary Packaging North China Pharmaceutical

packazinePharma · Issue 2011

Novartis | Facility of the Year Award 2011Roche | Efficient and Flexible Secondary PackagingNorth China Pharmaceutical Company | 10 Production Linesin 8 Months

Page 2: Pharma · Issue 2011 pack azine · Pharma · Issue 2011 azine Novartis | Facility of the Year Award 2011 Roche | Efficient and Flexible Secondary Packaging North China Pharmaceutical

2 | packazine Table of Contents | Editorial

www.boschpackaging.com [email protected]

News

Facts & Trends04 Anti-Counterfeiting | Protection from Falsified Medicines

06 125 Years Bosch | Partners in Innovation

Customers & Markets

Pharma08 North China Pharmaceutical Company | 10 Antibiotic Production Lines in 8 Month

11 Novartis | New Award Winning Production Facility

14 Roche | Flexibility with Minimum Footprint for the Secondary Packaging of Pharmaceuticals

17 Vetter | Vial Filling and Closing Solution Offers Tight Fit for Vetter’s New Chicago Facility

20 Turnkey Packaging System | High Performance in the Pharmaceutical Cleanroom

Events

23 Events 2011

CoverSafe and precise filling

of pharmaceutical liquids into injection bottles

08 11

Table of Contents

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Dear Readers,

In the year of Interpack 2011, Bosch has two reasons to celebrate: the company’s 125th anniversary, as well as the 150th birthday of its founder. This provides us with a

more than good enough reason to review the past – our aim is to connect our origins with our future. Bosch can look back on an eventful, as well as a powerful, history, which gives us an incentive for new and, above all, beneficial achievements.

Bosch Packaging Technology’s history dates back to 1861. The Hesser Company was founded that year and was later to become part of the Bosch family. In 2011, Bosch Packaging Technology can therefore look back on 150 years of packaging know-how. As early as the 1960s, Bosch was able to secure a powerful market

position and industry leaders like Strunck, Hamac-Hansella and Höfliger & Karg have joined the Bosch Group since. Under the Bosch umbrella, the tradition, experience and knowledge of various product brands are united, including well-known names like Demaurex, Doboy, Elematic, Makat, Moeller & Devicon, Pharmatec, Sapal, Schoeller-Bleckmann Medizintechnik, Sigpack, Tevopharm, Togum and Valicare.

However, without the trust of our customers, this anniversary would not have been possible. And, we will do everything we can to maintain and strengthen this trust over the next 125 years. We see ourselves in the tradition of Robert Bosch and his memorable phrase: “I would rather lose money than trust.” Now and in the future, creating quality products and keeping our promises take precedence over short-term gain and profit. In our sectors, good business relations are only possible by forming long-term partnerships.

We will be presenting our new products at Interpack, May 12–18 in Düsseldorf. Visit us in Hall 6. Let’s meet at Interpack to discuss your current and future projects. With our experience, we can offer the security of a competent and reliable partner for your machinery, from concept to commissioning.

Yours,

Friedbert Klefenz

14 17

Friedbert KlefenzPresident,

Bosch Packaging Technology

Editorial

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4 | packazine News Facts & Trends

Protection from Falsified Medicines: Anti-Counterfeiting Strategies

Counterfeit products can be found in all areas of life and almost everyone has come into contact with such products. Besides luxury goods, consumer goods, sporting goods and IT equipment, prod-uct piracy also affects spare parts for cars, drugs and, of course, bank notes. According to a statement by the Interna-tional Anti-Counterfeiting Coalition, the

worldwide damage caused to national economies runs to at least 600 billion US dollars each year and this figure is rising fast. The World Customs Organization estimates that counterfeit products account for between five and seven per-cent of global trade. However, the actual figure is likely to be much higher as many counterfeit goods go undetected.

Anti-Counterfeiting in the Pharmaceutical IndustryCounterfeit drugs are those which have arrived on the market as licensed drugs without having passed through the offi-cial channels. In such cases, the counter-feit drugs may contain the wrong active ingredient or may contain the correct active ingredient but in the incorrect

The number of product counterfeiting rises and it does not stop at

medicines. Anti-Counterfeiting helps to protect patients, makes counter-

feiting more difficult or even prevents it completely.

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quantity. In such cases, the best-case scenario may be that a drug becomes only ineffective. However, in the worst-case scenario, fatalities may occur if the illegitimately made drugs do not have the desired effect. Another consequence is that drugs with an incorrect composition may cause other illnesses, which could also ultimately lead to fatalities. The counterfeiters manufacture imitations not just of prescription drugs that are only available from a pharmacy, but also of over the counter (OTC) products, generics, originator products and tradi-tional drugs.

In 2006, the World Health Organization created the International Medical Products Anti-Counterfeiting Task Force, or IMPACT, in order to adopt and coordi-nate anti-counterfeiting measures.1

For IMPACT, drug control across the supply chain only goes as far as the pharmacy or the distributor and ends before reaching the patient. Patients should never be obliged to have to iden-

tify whether or not their drugs are origi-nal products. In February 2011, the European Parlia-ment adopted the “EU Falsified Medi-cines Directive”, which is required to be transposed into national law within two years. In addition to the introduction of safety features for prescription medi-cines (with exceptions), the Directive also provides for stricter regulations regarding the importation of active sub-stances and the improved control of the supply chain (including wholesale distri-bution). Regulations for Internet trading of medicines (including a public data-base for certified Internet pharmacies), the harmonization of Good Manufactur-ing Practise (GMP) inspections and the introduction of a pan-European early warning system upon discovery of a falsi-fied medicine (similar to the food sector) are also an integral part of this Directive.

The detailed transposition is being coor-dinated by working groups. The pharma-ceutical industry is also preparing itself

for the introduction of the data matrix code, in combination with the tamper evident closure, as a minimum require-ment. This comes as a recommendation by the European Federation of Pharma-ceutical Industries and Associations (EFPIA). Further requirements are to be expected, although it is not yet possible to give a detailed assessment of what these might be. Serialization, by provid-ing each package and not just each prod-uct with a unique number, is being im-plemented Europe-wide. Overall, accord-ing to the EFPIA, the industry welcomes the amendment to the current Directive 2001/83/EC.

For more information please contact:

Dr. Elke Sternberger-Rützel

Phone +49 (0)7951 402-826

[email protected]

1 http://www.who.int/impact/

FinalBrochureWHA2008a.pdf

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6 | packazine News Facts & Trends

Partners in Innovation

Packazine (P): For how long have you personally been working alongside Bosch?Felipe Cortes (FC): For more than a decade now – since I joined BI’s new Spanish plant in Sant Cugat, near Barcelona, in 2000.

P: Can you tell us a little more about the Sant Cugat plant? What technology has Bosch supplied over the years?FC: Our plant mainly produces human

pharmaceuticals for distribution to about 150 countries worldwide. When the plant was established in 1998, Bosch provided four complete lines for the sterile filling of glass ampoules, to handle all washing, sterilization, filling and identification processes. In 2010, two additional Bosch lines were installed, with two more to follow by the end of 2012.

P: What factors encouraged BI in your initial choice of, and continued relation-ship with, Bosch?FC: Bosch has consistently proven its un-derstanding of both our technological requirements and our forward-thinking, research-driven company ethos. Ampoule filling lines at our plant run for 24 hours a day, five days a week – as you can imagine, we need the most robust, reli-able equipment available teamed with round-the-clock service. Bosch’s unpar-alleled industry success, over such a long period of time, gives us a great deal of reassurance.

At BI, we sum up our approach to busi-ness with the phrase ‘value through innovation.’ In an industry defined by regulatory complexity, ever-changing consumer demands and the difficulties of working with high-potency substances,

we rely upon stable, accurate packaging equipment on which to build a solid platform for product innovation. Bosch’s principles, ‘Invented for Life’, and ‘Packaged as Promised’, summarize exactly what we need – innovation and reliability over the long-term.

P: How has the partnership developed over the years?FC: In short, very smoothly. Our Spanish plant is a really dynamic part of the business, with output increasing signifi-cantly over the last decade and line improvements being a regular require-ment. Bosch helps us to plan mechanical and electronic parts updates eight to ten months in advance so that we can imple-ment changes with minimal downtime. Design mock-ups and good project management make it possible to intro-duce these innovative modifications at a low cost.

Continued improvement is the founda-tion of our partnership. Direct communi-cation and open, frank discussion has allowed both Bosch and ourselves to benefit from each other’s expertise. At Sant Cugat, we have an excellent rela-tionship with our Bosch technicians – any incidents are solved with the utmost

Over 125 hugely successful years, Bosch has come to appreciate the

paramount importance of strong customer relationships. We spoke

to Felipe Cortes, Engineering Manager at Bosch’s long-term partner

Boehringer Ingelheim (BI) – one of the world’s 20 leading pharmaceu-

tical companies – about his experience working alongside the global

leader in packaging technology.

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Loading of ampoules at the washing machine of the compact line in isolator design.

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speed and efficiency, and all measures taken to ensure an extended product lifecycle. The level of trust we’ve built is invaluable.

P: What specific benefits have Bosch and its industry success brought to your company?FC: On our new ampoule lines, we’ve seen a 20 % net increase in output due, for instance, to robotic technology enhancements – each one now pro-

cesses up to 400 units per minute. Unlike other suppliers, Bosch has also allowed us to integrate control systems into the filling line, eradicating an outdated, man-ual process which cost us four or five minutes of downtime for every twenty minutes in operation. Equally, Bosch helped us to minimize the losses that arise from our three-week summer shut-down, allowing us to rapidly ramp back up to standard output level in less than 24 hours after the holiday.

Bosch’s industry success is passed onto us in the form of cutting-edge equipment and comprehensive, thorough after-sales service. We’d like to wish them a Happy Anniversary – may Bosch’s customers long reap the benefits of the company’s success.

For more information please contact:

Inga Strobel

Phone +49 (0)7951 402-648

[email protected]

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8 | packazine Customers & Markets Pharma

When opening their new, state-funded production facility, North China

Pharmaceutical Company (NCPC) faced an enormous challenge.

The company, based in Hebei Province, needed to equip the new

facility with ten entire powder filling lines for their antibiotic products

by a strict deadline in eight months time. With the opening date set,

and the attendance of key government figures confirmed, NCPC

turned to long-term partner Bosch to devise and deliver an innovative

solution within an unusually tight schedule.

Prompt Solution for NCPC 10 Antibiotic Production Lines in 8 Months

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A Partnership ContinuedInstalling such a large number of lines and complying with the meticulous safety standards demanded in the phar-maceutical industry required working alongside a supplier offering a wide range of competencies to the highest technological standards. Over years of professional collaboration with NCPC, Bosch Packaging Technology had already demonstrated its expertise in developing precise, reliable, flexible and high-output pharmaceutical filling lines. An existing relationship of trust combined with Bosch’s advanced concept and project management meant the company could offer the strongest solution for NCPC’s requirements.

A Four-Part ConceptTo safely package powdered antibiotics in sterile glass containers, each of the ten lines had to carry out four distinct tasks: container cleaning; drying and sterilization; filling and closing; and the

application of an aluminium cap. By join-ing forces at its sites in Crailsheim (Ger-many) and Hangzhou (China), Bosch was able to offer cost-effective, leading-edge equipment for the entire production and packaging process. The four machines were constructed to suit NCPC’s exact needs, with customer visits ensuring their continued approval.

Pharmaceutical industry hygiene stan-dards demand complete sterility of pri-mary packaging. Bosch ensured the en-tire filling and capping process, situated in unbroken Class A clean room condi-tions, would stand up to the most strin-gent inspections.

An Unbroken ChainIt is vital to prevent any contamination of sterilized and depyrogenated bottles, especially in a line operating at through-puts of up to 300 containers per minute. To maintain sterilization, it is essential that all components of the line are fully

integrated and products move quickly through the production process.

NCPC’s packaging chain begins with the Bosch RRU cleaning machine, which balances robust, residue-free cleaning with gentle handling. Following an ultra-sonic bath, the bottles are transferred to a rotary system via plastic grippers, specifically designed to minimize the contact area for a better cleaning result.

The containers then pass through the HQL sterilization tunnel, which uses the vertical Hot Air Laminar Flow principle to sterilize and depyrogenate the vials at 320-degrees Celsius. Once the drying and sterilization is completed, the bot-tles are conveyed quickly trough the cooling section, and are then transferred for filling.

The Bosch AFG 3000 compact filling machine provides fast, gentle convey-ance and accurate, dust-free dosing. In

1 2

1 Reject station via vacuum starwheels.

2 Horizontal rotating cell transport, good accessibility from the front position.

3 Dosing station with vacuum pressure.

3

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10 | packazine Customers & Markets Pharma

the heart of the machine lies the central dosing system, which operates using the vacuum pressure principle. Due to this unique dosing method the vials are filled very precisely: First, the AFG 3000 transports the powder by vacuum into a dosing chamber and then doses the product with sterile compressed air into the container. After each dosage the dos-ing chamber is cleaned with additional sterile compressed air. To minimize the risk of particles, rubber stoppers are fed horizontally from a supply hopper and pressed in tightly with a horizontally operating vacuum wheel.

The fourth and final step is carried out by the VRK capping machine that creates tight, complete seals using Bosch’s

unique overseal capping method. Each container is compressed and a rotary crimping role is moved in against the cap, providing the best quality crimp with the lowest generation of particles.

Across the system, parameters for differ-ent processes can be stored and recalled at the push of a button for reproducible cycle times and easy operation that mini-mizes operator error. Similarly, format change is simplified by eliminating the need for tools and easy accessibility across the line.

A Resounding SuccessDespite unprecedented time constraints, NCPC was able to install the equipment in its new plant in time for the scheduled

opening. Bosch delivered on its ambi-tious promises, channelling all available resources and expertise into a highly- focused project.

The result is an innovative, robust and long-term solution to an urgent require-ment. Since the completion of this project, NCPC has already placed an or-der with Bosch for two further packaging lines.

For more information please contact:

Armin Ziegler

Phone +86 (0)571 87265062

[email protected]

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Novartis Vaccines and Bosch Combine for New, Award Winning Production Facility The 2011 Facility of the Year Award for Equipment Innovation went to the Novartis Vaccines

Marburg Site project. Part of this success was due to the high-purity media, CIP/SIP and sterilization

systems installed by Bosch.

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12 | packazine Customers & Markets Pharma

Rabies and tick-borne encephalitis (TBE) continue to be dangerous diseases. In Asia, rabies is still a very real threat for many people, and TBE is spreading throughout Europe. A secure supply of life-saving vaccines therefore remains vital and is a corporate goal of Novartis Vaccines.

With its Marburg Site project Novartis Vaccines undertook the largest ever investment in a single project at the Marburg location. In just 26 months, the company created a vaccine production plant with ancillary services, a ware-house and facilities for quality control and environmentally friendly energy pro-duction. This state-of-the-art complex will employ 300 staff and is aiming for an annual production of up to 40 million doses of vaccines for global markets, thus further extending Novartis’ leader-ship in this field.

Award for Innovative TechnologyThe Marburg Site project has now won the 2011 Facility of the Year Award from

The International Society for Pharmaceu-tical Engineering (ISPE). Marburg Site beat off competition from 25 other projects, across eleven countries, to win the award, impressing industry experts with both the scope of the project and the pace of its implementation.

This is the first such award for a Novartis facility and Martin Posingies, Project Manager of the Marburg Site production facility has been appreciative of the role that Bosch has played in helping the project achieve such high recognition: “Bosch is very much part of this success. An ambitious project like Marburg Site can only be realized with excellent part-ners who, even if there are unexpected problems, can react quickly and in a competent and coordinated manner.”

Success through Synergies and Reduction of InterfacesPharmatec and Schoeller-Bleckmann Medizintechnik (SBM), which are both part of Bosch Packaging Technology, were responsible for the design, supply

and installation of five Cleaning/Steriliza-tion In Place (CIP/SIP) units, two pure steam and two Water for Injection (WFI) generators, as well as eleven equipment sterilization units with vacuum-steam procedure (autoclave models). Process-ing as many as eleven autoclaves pre-sented SBM with a logistical problem but, despite this high workload, the manu fac-turing network, with its SBM partners, rose to the challenge. Acceptance tests and on-site assembly and commissioning were conducted very efficiently and with optimum use of resources.

For Novartis, working with Bosch as a one-stop provider not only delivered a transparent and efficient realization of the project but also resulted in service technicians remaining on site for the long term. This allowed speedy and flexible reactions to special acceleration and interface optimizations involving third parties. With their modular design struc-ture, such working practices were partic-ularly beneficial during the installation of the CIP/SIP units, which were put into

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operation without any major delays. This contributed greatly to the speedy com-missioning of the process equipment. As Posingies explained, “Once the first modules were operational, we could apply the same technical knowledge for subsequent installations, allowing us to incorporate new machinery quickly and virtually overnight. Interface and communication with the superordinate DeltaV process control system was highly reliable from the start.”

The customer benefits of Bosch’s “one-stop shopping” concept became very apparent in the Marburg Site project. Novartis carried out the configu-ration and implementation of the CIP/SIP and sterilization solutions with a single point of contact but, at the same time, was able to profit from the know-how of two highly specialized Bosch subsidiaries. Aside from the technical aspects, contractual and commercial considerations have proved to be

particularly beneficial to Novartis, as all agreements remain in place over the entire supply period.

For more information please contact:

Daniel Dämmig

Phone: +49 (0)351 28278-688

[email protected]

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14 | packazine Customers & Markets Pharma

Flexibility with Minimum Footprint for the Secondary Packaging of Pharmaceuticals

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The box carriers allow to handle a variety of box formats, without requiring additional change parts or mechanical holders.

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For more than 100 years, Roche has pioneered many medical breakthroughs, as an innovator of products and services for the early detection, prevention, diagnosis and treatment of diseases. The Switzerland-based company’s mission is to create added value in healthcare by focusing on its expertise in diagnostics and pharmaceuticals.

Roche’s Diagnostics Division has recently required a new solution for the second-ary packaging of its CoaguChek diagnos-tic strips, which are used for home, or point of care, testing of blood clotting time, enabling patients to avoid repeated visits to a hospital-based anticoagulation clinic.

The full CoaguChek product consists of diagnostic strips packaged in plastic

tubes, read only memory chips contain-ing calibration data and information leaf-lets, which all have to be processed for secondary packaging in boxes and fitted with labels and code strips. The main selection criterion for the new line was to increase production efficiency while maintaining full process control. As a result, gentle product handling and reli-able packaging of all components were key requirements.

The new solution also required flexibility for handling different formats and com-ponents, as well as the ability to produce very small batches in a confined space.

A Reliable, Experienced Partner For the realization of this project, Roche needed a partner with the necessary technical expertise to meet all require-

ments and the capability to develop a reliable and efficient solution. Roche therefore decided to choose Bosch Packaging Technology and its Pharma Toploader TTP, which has been specially developed for the pharmaceutical indus-try. This new machine is a compact and integrated solution, which delivers high output while ensuring maximum product safety and highly convenient operation.

The secret of the TTP’s success is the combination of a space-saving rotary system with an innovative box transpor-tation and corresponding loading and infeed modules. Thanks to its compre-hensive experience in the field of auto-mation, Bosch was able to adapt its solu-tion perfectly to Roche’s specifications and take care of all additional requirements.

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Flexibility and SpeedThe TTP is designed to provide the high flexibility increasingly demanded by producers in the secondary packaging of products such as vials, pre-filled syringes, ampoules and tubes, plus any other components to be included. It achieves its high format flexibility by applying vacuum technology to hold boxes in position while on the transpor-tation device. This ensures safe and care-ful product transport, as well as facilitat-ing and speeding up format changes. This allows the box carriers to handle a variety of box formats, without requiring additional change parts or mechanical holders. For fragile products, there is an option to insert product holders in the boxes to secure the content.The entire installation, including various integrated functions, can be easily oper-

ated via a central Human Machine Inter-face (HMI). In addition to good process visibility and easy access, all products ejected from the process accumulate at defined discharge points, which allows simplified line clearance in the final stages of batch production.

As a result of its modular design, the Toploader provides the option of simply docking on additional modules, or com-ponents, such as labeling units and checkweighers. This allows for process-dependent configuration adapted to customer requirements.

Highly Versatile SystemThe Pharma Toploader TTP enables Roche to profit from a forward-looking, market-oriented and efficient solution perfectly tailored to its requirements.

With a minimum footprint, the new pack-aging line takes care of all required pro-duction procedures.

Short changeover times increase the machine’s availability and allow for the production of the required volumes while maintaining high levels of efficiency. In addition, the Pharma Toploader TTP allows the line to be accurately adapted to a wide variety of customer require-ments. It provides pharmaceutical com-panies with a system that offers full process stability and ensures reliable operation.

For further information please contact:

Theo Zens

Phone +41 (0)58 674 6203

[email protected]

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Leading contract manufacturer Vetter, headquartered in Ravensburg, Germany, has stood for quality,

innovation and strategic partnership in biotech and pharmaceuticals for more than 25 years. When

the company needed new equipment for the small-batch filling, capping and sealing of vials for

substances in preclinical development through phase I & II at its new Chicago site, it was looking for

a partner who could provide the highest levels of guidance and technical expertise. In close

consultation with Vetter, Bosch was able to install and implement a system that offers the flexibility

and robustness needed.

Vial Filling and Closing Solution Offers Tight Fit for Vetter’s New Chicago Facility

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Priorities FirstThe project was demanding – handling products from companies ranging from small biotech developers to leading pharmaceutical and biotech manufactur-ers, the equipment had to be able to process small batch sizes of different substances while performing a steady and safe production process. In addition Vetter, a leader in the use of restricted access barrier system (RABS) technology in cleanrooms, needed a partner on par with its cutting-edge developments. Turning to filling, isolation and contain-ment technology expert Bosch Packaging Technology, the company enlarged its US early stage drug development support portfolio.

When devising the initial line concept, Bosch and Vetter were clear about the priorities. Systems handling highly sensi-tive substances require particularly high quality standards, as well as a robust design. As pioneers in their fields, both companies joined forces to develop a

customized, closed RABS for complete product and operator safety. The line itself needed to be adaptable to handle a wide variety of substances and allow for quick, safe and easy changeover.

Safe and SealedThe core of the line is Bosch’s MHI 2020 B Vial Filling and Closing Machine, which features integrated testing technology and is designed to take care of the entire vial filling and closing process. Due to the small batch sizes produced at Vetter’s Chicago site, vials are fed manually to the turntable with sterilized gloves. A robotic Pharma Handling Unit takes the vials and places them in the multi system filling station, providing safe handling and gentle transportation for both glass and plastic containers. While automated start-up contributes to minimal product loss, acceleration of the transport system can be varied to avoid contamination of the inner container surface.The filling station of the MHI allows for use of both peristaltic and diaphragm

pumps depending on the product. Disposable pumps are used when rapid changeover and cleaning times are needed as well as stringent product safety and integrity. The machine’s i n-process weight control function features selectable weighing modes for different volumes and products to support flexibil-ity and highly precision filling. This mini-mizes rejects and product waste while a high-speed weighing mode allows pro-cesses to be completed quickly and effi-ciently. A second Handling Unit picks up the vials and places the stopper immediately after filling. All vials are 100 percent stop-pered and sealed with an aluminum over-seal prior to machine exit for a mini-mized reject rate and high yield. Intelli-gent interaction between the transport system, In-Process Control feature, filling and stoppering tasks makes for a self-monitoring, self-controlled filling process that ensures fed containers are precisely filled and securely closed.

1

1 MHI 2020 B with integrated overcapping station and open RABS guarding.

2 Suspended transport with robotic handling unit.

3 Dosing station in combination design.

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Solutions Fit for a JourneyThe MHI 2020 B is designed to minimize intervention during operation, format changes and maintenance work. The layout permits good accessibility and minimizes floor space for a small foot-print. Programmable servo drives allow all production parameters to be saved and recalled in a recipe and the operat-ing system can be adjusted for different container sizes and fill volumes easily without the need for manual adjust-ments.“The combined result of Bosch’s and Vetter’s expertise is a line that delivers in

all areas”, said Henryk Badack, project manager at Vetter. “It not only performs the high technical standards and custom-ization that drew the international contract manufacturing company Vetter to Bosch, but also offers the flexibility and speed needed for the filling of high- quality clinical trial material.”

For further information please contact:

Dieter Bandtel

Phone +49 (0)7951 402-362

[email protected]

3

2

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High Performance in the Pharmaceutical CleanroomTurnkey Packaging System for Stick Packs

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Aside from new product and market re-quirements, the entire packaging process is centered on cost-effectiveness. Fast reactions to changing product character-istics, the safe processing of new pack-aging materials, the launch of additional carton presentations and an increase in production will all determine success in the marketplace. With this in mind, a German pharmaceutical supplier has re-cently turned to Bosch for a new Stick Pack packaging solution.

Project DriversThe requirements for a Stick Pack line are quite complex. Precise dosage, high and reliable tightness of the primary package, fast interface handling and reliable cartoning at high cycle speeds all contribute to the success of the line. In this case, the process task consisted

of packaging pharmaceutical powders in Stick Packs, followed by cartoning and including options such as coding, leaflet insertion and weighing. Alongside secure pouch tightness and precise powder dosing, a very high flexibility of the secondary packaging process was also required. With quantities of up to 50 Stick Packs per carton, the option of having a total of seven carton formats to be loaded was also necessary.After assessing the performance and quality parameters, a Bosch 10-lane RA Stick Pack machine and a CUT 120 hori-zontal cartoner were identified as the best solution for the pharmaceutical company. An important additional factor concerned the layout, which needed to comprise of a compact line with good accessibility, which integrated into exist-ing cleanroom arrangements.

Auger Filling ModuleTo meet the demands for high speed and accuracy, the 10-lane RA Stick Pack machine is fitted with a swiveling, and therefore highly accessible, auger filling module. At 100 cycles per minute, the Stick Packs may be filled with dosages of between one and three grams of the product. Individual AC servo-controlled filling augers guarantee high weight ac-curacy and a check-weighing system, based on single-pouch weighing and ten-dency control, checks the weight of ev-ery one of the manufactured Stick Packs. The dosage may be adjusted to product-specific density variations, ensuring a consistently high dosing accuracy. Following the check-weighing procedure, the system proceeds with counting, grouping and cartoning the Stick Packs.

Packaging system containing a Sigpack RA Stick Pack machine and a horizontal cartoner type CUT 120

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Flexible CartonerThe intermittent CUT 120 horizontal cartoner is an example of how Bosch manages to balance reliable production, format flexibility and easy access in its machines. Slanted guards, partitioning and concealed cabling ensure GMP-compliant design. The clear structure

and a circular protective guard, which is completely retractable underneath the machine, ensure quick access at all process stages.

The large format range allows for highly diverse applications and, due to the low number of set points, the operator can

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perform fast and reproducible format changes. Using stored format data, the system quickly guides the operator through the changeover process. The machine also has a modular design and may be retrofitted to suit changed conditions.

High Quality ServiceCustomer-oriented and product-specific packaging solutions, competent project management and a vertical production start-up following commissioning of the packaging system are key factors in this successful project. With individual training, technical audits and service products, Bosch Packaging Technology ensures safe operation over the entire life cycle of the packaging line.

For further information please contact:

Uwe Jansen

Phone + 41 (0)58 674 7458

[email protected]