pharma · issue 2012 - syntegon japan1.pdfhealth by producing high-quality pharma-ceutical products...

packazinePharma · Issue 2012

Bright Future | Handy stick packs for penicillinAlmac | New capsule filling line for capacity expansionChemolux | Maintenance with foresight

2 | packazine Table of contents | Editorial

www.boschpackaging.com [email protected]

News

Facts & Trends04 Drug Delivery Devices | Simplifying the lives of patients

Customers & Markets

Pharma07 Bright Future | Handy stick pack for penicillin

10 IBSA | Improvement of pre-filled syringe production in Italy

12 Ferring | Eco-friendly fluid bed system in operation after only eight months

14 Almac | New capsule filling line for capacity expansion

16 Sterilizers | High machine availability for contact lens producers

Other Industries18 Beautycos | Skin care products reliably filled to high quality standards

20 Chemolux | Maintenance with foresight

Events

22 Events 2012

CoverThe Hüttlin HKC 400 DJ fluid bed system coats

pharmaceutical granulates.

07 10

Table of contents

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Dear readers,

Looking back on last year, the international growth strategy of Bosch Packaging Technology has paid off. We were able to increase sales significantly, meaning we

have again grown faster than our relevant market. We are pleased about that development and are looking ahead very positively.

With the acquisition of Hüttlin and Manesty in 2011, we further expanded our portfolio in the pharmaceutical process technology. Hüttlin, based in Schopfheim, Germany, produces specialist drying and granulation equipment for pharmaceutical powders. Manesty, based in Knowsley, near Liverpool in the United Kingdom, specializes in tablet presses and coaters. And, we are continuing our growth: in April, the acquisition of the machinery business

companies of Eisai Co., Ltd., was approved by the antitrust authorities without further restrictions. This leading Japanese pharmaceutical company, based in Tokyo, specializes in the manufacture, sales and export of inspection equipment as well as pharmaceutical machinery and packaging materials.

Adding these competencies to our portfolio further enhances our position as a full-range provider to the pharmaceutical industry. Following our One Stop Shopping approach, we are able to offer our customers even more flexibility and the reliability of a competent partner for process and packaging technology, inspection, validation and qualification.

Visit us in Frankfurt, Germany, at Achema 2012, the leading international meeting point for the industries of chemical engineering, environmental protection and biotechnology, which is being held from June 18 to 22. We will be presenting Bosch innovations for liquid and solid pharmaceuticals and look forward to meeting you to discuss your present and future requirements and projects!

Yours,

Friedbert Klefenz

16 18

Friedbert KlefenzPresident,

Bosch Packaging Technology

Editorial

4 | packazine News Facts & Trends

Drug Delivery Devices currently range among the major pharmaceutical

trends. Their optimization is largely influenced by the pharmaceutical

industry, physicians and patients. Present developments of new

devices are increasingly focused on patients’ needs. They give top

priority to simplified handling, reduced pain, continuous documenta-

tion and facilitated adherence to medication intervals.

Simplifying the lives of patients

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A precise definition of Drug Delivery Devices (DDD) is almost impossible to find. In general, DDDs support the transportation of active ingredients to the part of the body where they are needed and therefore can be considered as application facility. Whether they are defined as pharmaceuticals or medical products depends on their purpose. For example, a powder inhaler qualifies as a pharmaceutical, while a catheter dissected with heparin qualifies as a medical product.

Pen systems: close to perfectionDue to a significant refinement of most DDDs in recent years, for some appli-ances currently only little potential for improvement is left. The introduction of pen systems in 1985 considerably enhanced patients’ quality of life. Pens are loaded using cartridges and usually serve as multiple application systems. Several functionalities such as level indication and haptic of pen systems already have been optimized. Moreover, today’s pen systems feature electronic components like memory control which is mainly an application for children. In future, further refinement will focus on easier and safer handling, as for instance improved needle protection to help avoid injuries and unintended application.The optimization of other parenteral sys-tems also focuses on the patients’ com-pliance, reflecting the awareness of fears such as needle phobia. Auto injectors are usually loaded using pre-filled syringes and feature a needle cover keeping the

needle hidden as long as possible. This often helps users to overcome fears associated with self-injection. Diseases such as multiple sclerosis, osteoporosis, hepatitis, rheumatism and anemia are typical fields for the application of auto injectors. Treatment of these requires a singular dose or regular administration during longer intervals and is profit-able from the industry’s point of view. Therefore, intensive development of auto injectors is not only justified to improve patients’ quality of life but also from an economical perspective.Further advancements mainly refer to production conditions. With optimized materials and designs, production costs will decrease. As a result, devices are no longer too expensive to be applied as re-usable items. Some experts believe needle-free injection technology will soon prove to be successful. One of the reasons is the vaccine campaign launched by the World Health Organization (WHO). However, the pharmaceutical market remains cautious on these systems because they are believed to cause similar pain as a puncture does.

Transdermal devices: more convenienceTransdermal delivery devices are patch systems containing active agents, for instance within matrices, which are dif-fused through the skin. Recent develop-ments have led to optimized patch sizes and adherence features of the patches for better skin tolerance. A general trend in the western world goes towards

the usage of and affinity for electronic devices, influencing also pharmaceutical applications. Exciting new developments comprise a combination of patch and pump, so-called “patch pumps”. This can be illustrated on example of the Pancreum BetaWedge insulin pump. The small device with a Bluetooth-enabled Personal Diabetes Analyzer (PDA) adheres to the skin and delivers insulin for as long as three days. Electronic devices such as technologically suitable MP3 players and memory cards enable easy and convenient measurement of the blood sugar level.With “MyDose,” Roche is currently de-veloping a single-use infusion device for the subcutaneous delivery of a new drug formulation containing monoclonal anti-bodies such as Herceptin and MabThera. The subcutaneous delivery is based on the patients’ individual bodyweight or surface. It is easier to administer and application times are significantly reduced. The main functional component of the device is the “Vartridge,” a hybrid container which combines the features of glass vials and cartridges and is con-trolled via the electronics in the pump. As opposed to intravenous applications, patients no longer need to be treated in hospital and are more independent in their everyday routine.

Pulmonary systems: focus on asthma and COPDInhalable insulin seemed to hold a lot of promise. But the large size of the inhaler, increased treatment costs and

6 | packazine News Facts & Trends

the requirement for much higher insulin doses led to its withdrawal. The market for pulmonary systems has noticeably slowed down in the developed countries while it is still growing in the emerging markets. Yet pharmaceutical engineers continue with the advancement of these systems mainly with respect to asthma and COPD (chronic obstructive pulmo-nary disease). There are three different types of pulmonary systems. MDI (metered dose inhaler) is the most common technology in the market at low cost level, especially for emergency products. The aerosol-

based inhaler delivers the required amount of gaseous medicine to the lungs. New products however are rarely devel-oped in the form of MDIs for environ-mental and compliance reasons such as patients’ coordination problems between breathing and actuation. The technology of the future – if no oral medication is available – is the DPI (dry powder inhaler) with its simple application and small size. Medication is delivered to the lungs in form of dry powder which patients inhale without any solvent. The third pulmonary system is the nebulizer, which administers the inhalation liquid in form of fine drops. Patients inhale the medication as a mist generated by different technologies such as ultrasound, piezo crystals or vibrating mesh.

DDD – key to success of a new drugMany established medical devices, and especially applications for children, have been significantly optimized over the past years. From a current perspective, some of them are approaching their improvement limits, others still have

much potential for further refinement. In general, the equipment tends to be smaller, and handling is safer, easier and more convenient. At the same time, costs are decreasing for those devices that hardly require any further improve-ment. In many fields, the market will not work without DDDs. The compatibility of a device such as a pen, an auto injec-tor or a pump with a new drug is an important precondition for its success, especially in the developed countries. The so-called “pharmerging markets” currently require more basic and afford-able technologies. Once the average unit cost decreases, the optimized DDDs will also be successfully placed on these markets in large numbers. In the future, the trend towards more convenience with a clear focus on patients’ compli-ance is expected to continue at a smart pace.

For more information please contact:

Dr Elke Sternberger-Rützel

Phone: +49 711 811 579 93

E-mail: [email protected]

The reusable Ypsomed ServoPen with intuitive handling, is a pen system for insulin injection enabling easy everyday usage.

Moeller & Devicon, a Bosch Packaging Technology company, has a broad product portfolio including state-of-the-art medtec assembly and handling equipment for pen systems, micro pumps, catheters, tube winding, dry powder inhalers (DPI) and needle-free injection devices.

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The market for stick pack applications in the packaging of pharmaceutical products grows steadily. Also in China this handy pack style is increasingly used. Reasons for the rising popularity are obvious: minimal material consump-tion, a fast and safe packaging process, and a convincing packaging system with a small footprint.

From sachets to stick packsEstablished in 1993, Bright Future Phar-maceutical Ltd. has become Hong Kong’s largest GMP-certified (Good Manufac-turing Practice) supplier of pharmaceu-tical products. The company now oper-ates six fully equipped production plants and commits itself to improving people’s health by producing high-quality pharma-ceutical products using state-of-the-art technology.

Handy packaging solution for high-quality pharmaceuticals

Until now, Bright Future marketed penicillin powder packaged in sachets (flat pouches). An increase in sales recently led to the decision to search for a packaging solution consuming less material. Stick packs proved to be a suitable option. Bosch Packaging Systems was able to offer a packaging line fulfilling all required parameters for performance as well as quality. Apart from high demands regarding pouch

Bright Future opts for stick packs

8 | packazine Customers & Markets Pharma

integrity and accurate powder dosing, it was considered crucial to ensure lean processes over the project course in order to minimize resource usage. The stick pack itself is fitted with a perfora-tion for unambiguous and safe opening and thus ensures easy tearing as well as fast and complete emptying of the package. Bright Future now markets its penicillin as a flow-wrapped multipack containing six single stick packs.

Primary and secondary packaging from one sourceThe requirements for a stick pack pack-aging line are highly complex. Besides

dosing accuracy, reliably high tightness of the primary packaging and safe interface handling are important factors. Additionally, a dependable secondary packaging needs to be ensured. The PLC-controlled system from Bosch achieves maximum reliability while having a small footprint. Both primary and secondary packaging are offered by a single supplier. Primary packaging into stick packs involves precise dosing on the ten-lane vertical Sigpack RA machine. The subsequent secondary packaging process is carried out on the horizontal Sigpack HCM flow wrapper. With an output level of 175 packages, the HCM

flow wraps up to 1000 stick packs per minute.Individually AC servo-controlled filling augers ensure the required dosing accuracy for the primary packaging operation. As the density of penicillin powder may be subject to fluctuations, individual weighing of each stick pack is indispensable. After weight checking by an in-line weighing system, dosing at the machine is regulated via an integrated tendency control. This continuous ad-justment ensures a consistently accurate filling process. Following the weighing procedure, the stick packs are counted, grouped and fed towards the Sigpack HCM flow wrapper. Each sales unit packaged on the Sigpack HCM consists of two stacks with three penicillin stick packs each in a particularly flat and compact flow wrap. The new secondary packaging is produced efficiently using less material and offers easy handling to the end user.Frank Bühler, responsible Product Manager at Bosch, emphasizes the dosing accuracy of the Sigpack RA as well as the flexibility of the Sigpack HCx machine platform, “Precise dosing is realized at high cycle speeds without product loss. As another benefit regard-ing sealing quality and product integrity, sealing stations with extended sealing times are available besides the rotary sealing method. Depending on custom-ers’ needs, the Sigpack HCM is also suitable for ultrasonic sealing technology for the packaging of highly temperature-sensitive products.” GMP-compliant design meets customer expectationsSince its foundation Bright Future has been committed to the promotion of public health. For the company, the quality of its pharmaceutical products is of highest priority. In manufacturing,

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Bright Future also strictly follows GMP and GLP (Good Laboratory Practice) principles. The line’s GMP-compliant construction therefore meets a further customer demand. The cantilever design completely separates process and drive units. Additionally, an ergonomic operat-ing height improves operator access and allows for a direct view into the packag-ing process. “Format changes and infeed of packaging material can be realized fast and easily,” Frank Bühler stresses. “Lifetime-lubricated components also contribute to the line’s hygienic design.” The machine casing guarantees safety and noise protection. Below the product transport unit, the machine elements are fully visible for a facilitated line clear-ance. Depending on customer needs, rejected products and product waste can be collected in special lockable contain-ers or on catch plates.

Human Machine Interface adjusted to pharmaceutical applicationsThe crucial operating functions such as Start, Stop and Emergency Stop are integrated on the line’s front. All other functions are accessible via a pivoting Human Machine Interface (HMI) with 12" color touchscreen. The HMI is avail-able in two different specifications for pharmaceutical applications. In addition to the basic version used by Bright Future, a second configuration level fully complies with the requirements of 21CFR part 11. It features integrated functions such as audit trail, electronic record and RAID data protection to en-sure GxP-compliant operating and data management. Connection to higher-level MES systems is also possible.The new Bosch line enables Bright Future to package its penicillin powder using less material while increasing efficiency. Simultaneously, the easy-to-

open stick packs enhance convenience for the end user. “To supply our global customer base with reliable pharmaceuticals and health products we were looking for a competent partner offering high-quality equipment. With Bosch Packaging Systems, we found such a partner,” says Dr Susanna Wan, Purchasing & Development Manager at Bright Future. She is looking forward to a successful conclusion of the project and the commissioning of the new line scheduled for summer 2012.

Bosch will be presenting this packaging system at Achema 2012 in Frankfurt from June 18 to 22.


Frank Bühler

Phone: +41 58 674 8928


On the ten-lane vertical Sigpack RA stick pack machine, the required dosing accuracy is permanently ensured. With its integrated in-line weighing system, the Sigpack RA checks each stick pack for weight and regulates dosing at the machine via an integrated tendency control.


First nested syringe filling line delivered to Italy

Best attitude towards the projectIBSA Farmaceutici Italia, a subsidiary of the Swiss Institute Biochimique S.A., is specialized in small-volume produc-tion of aseptically filled and sterilized pharmaceuticals. This includes 16 million pre-filled syringes per year containing so-dium hyaluronate for intra-articular and intradermal use. Physiological solutions used as solvent for freeze-dried powders amount to 2.2 million syringes per year. Recently, a new production building has been added to IBSA’s site in Lodi, close to Milan. To improve processes for its pre-filled syringes filled in aseptic condi-tions, the company decided to equip the plant with a Bosch FXS line. After contacting several potential vendors and completing a technical and economic evaluation in 2008, IBSA decided to run the project with Bosch. “Bosch designers and technicians showed the best attitude towards the project and were very fast in accepting our specifications,” says Roberto Maglio, Engineering & Maintenance Manager at IBSA. On the new line, IBSA will mainly produce diclofenac, an anti-inflammatory active pharmaceutical ingredient used for muscular and rheumatic treatment. In a further step, the company also plans to fill hyaluronic acid for intra-articular and intradermal use.

Bosch has installed its first FXS nested syringe filling line in Italy. IBSA Farmaceutici Italia was looking

to improve its pre-filled syringe production. The whole implementation process at IBSA’s new production

building in Lodi turned out to be highly satisfactory and beneficial for both sides.

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Configured according to individual needsThe new nested syringe filler for pre-sterilized syringes produces at medium to high rates. IBSA achieves an output of 12 000 syringes per hour with watery products and 6000 syringes per hour with viscous products. “Viscous products are filled and stoppered under vacuum, hence the lower output rate,” Maglio explains. The line is based on the FXS 3100 nested syringe filler. Combined with an ABO 5000 bag opener and an ATO 5000 tub opener, as well as open RABS (restricted access barrier system) technology, the line was configured to the special requirements of IBSA Farmaceutici Italia. “Throughout the project, Bosch was always open to new suggestions, and quickly implemented our modifications,” says Roberto Maglio. Paola Emaldi, responsible for quality assurance at IBSA’s Lodi site, adds, “The project was not only about the filling of our syringes; the complete process needed to be taken into account. We had to pay particularly high attention to micro-

biological contamination issues.” During the process, the empty sterile syringes contained in tubs are moved from the non-sterile area to the cleanroom area. During this critical transfer, the sterility of the syringes must be ensured at all time. Microbiological controls are executed by high precision instruments being able to detect microbial contami-nation in real time. They prove that no contamination occurred.

Benefits on both sidesDuring the testing and implementation phase, both companies benefitted from each other’s knowledge and working conditions. “IBSA could draw on Bosch’s expertise and flexibility for the line configuration. Together, we managed to achieve a truly reliable aseptic process,” Roberto Maglio explains. The first series of factory acceptance tests (FAT) were performed at Bosch’s location in Crailsheim, Germany. After only six weeks, the line was shipped to Lodi, where more tests and adaptations were performed. Both companies profited from testing at the actual place of production, including

cleanrooms grade A, B and C.For the specific application at IBSA’s plant in Italy, some changes to the line configuration were required. Both the machine shape and the dimensions of critical machine parts were adapted. This enabled a smooth air pathway and material movement to and from the classified areas without contamination. Only after the line had been installed and the environmental conditions completed, final tests could be carried out. The results confirmed that all improvements had been successfully implemented. “The entire Bosch team was very commit-ted. Clearly, their job not only consisted in the execution of a contract. Everyone involved was continuously seeking to improve processes and to find the best solutions for IBSA,” Roberto Maglio emphasizes, adding that this attitude “really came out naturally”.


Klaus Ullherr

Phone +49 7951 402 517



Treatment “on the body’s own terms”Ferring Pharmaceuticals, with head-quarters in Saint-Prex, Switzerland, is a research-driven biopharmaceutical company that develops and manufac-tures innovative pharmaceuticals in the fields of reproductive medicine, urology, gastroenterology, endocrinology and

obstetrics. The company sees it as its mission to provide medications in these therapeutic areas that enable physicians to optimize their patients’ treatment “on the body’s own terms,” as Ferring puts it. Ferring and Hüttlin, Bosch affiliate since 2011, can look back on a successful long-term cooperation. Initially, a Hüttlin

coater unit was installed at the former Copenhagen facility as early as 1986. A small-scale unit is operating at Ferring’s pilot plant since 2010. In 2004, the Swiss factory received a new, upgraded unit and a second one is currently under construction in Saint-Prex, to start operation in 2013. “The technology is well accepted by Ferring’s production team,” says Jérôme Serrurier, Process Engineer at the Saint-Prex facility.

Tailor-made for complex processesFerring opted for a tailor-made fluid bed system for the coating of its pharma-ceutical granulates. “The main difficulty in this complex process is to maintain consistency between batches within the release specifications of the product. As the process involves an organic solvent, measures are required to avoid any environmental, health or safety issues,” explains Jérôme Serrurier. The technology has increased the level of automation and equipment service life, shortened process and cleaning times, speeded up filling and dis charging, and significantly reduced nitrogen con sumption.Prior to installation, the system was tested on a small scale at Hüttlin’s in-house laboratory in Schopfheim, Germany. The required capacities and parameters were then scaled up for the Ferring plant. After only eight months, the plant was put into full operation. The Hüttlin HKC 400 DJ, based on patented

Eco-friendly and long-lastingFerring Pharmaceuticals’ multi-purpose site in Saint-Prex, Switzerland,

has been equipped with an environmentally friendly closed-loop plant

for organic solvent. The plant was designed and constructed according

to Ferring’s requirements and put into operation after only eight months.

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Hüttlin disk-jet technology, is the center-piece of the plant. Together with its peripheral units – air dehumidifier, low-temperature condensation unit, process gas heater, HEPA filters, dedusting unit and ventilator – it forms a closed loop, bathed in nitrogen. The equipment is ex-tremely easy to operate and satisfies the most exacting environmental standards.

Environmentally sound operationSolids are fluidized by means of a special patented disk-jet gas distributor plate through the inflow of process gas. This process generates a toroidal product flow, providing complete and gentle mixing and homogenous spraying. “Our products are produced under extremely strict specifications. Easy control and homogenous coating processes are fundamental to ensuring repeatability, batch after batch,” Jérôme Serrurier emphasizes. Depending on the process gas conditioning, the solids can be

dried, heated, moistened, cooled or ag-glomerated by the injection of excipients. Coating agents can be sprayed onto the fluidized product to coat particles.A closed-loop system for process gas with an integrated two-stage solvent re-covery process supports environmentally sound and economic operation of the equipment. A brine-cooled condenser and low-temperature condensation unit with liquid nitrogen allow the organic sol-vent to be almost completely recovered. The three-component nozzles spray the coating fluid directly into the fluidized product. The nozzles are cleaned with pure organic solvent in an integrated process step. This enables the nozzles to remain in operation over long periods.

A cooperation to be continuedThe successful cooperation enjoyed by the two companies relies on two key elements: human and technological expertise. “The team consists of highly

professional experts. Each project is supported by specialists according to the specific needs involved,” Jérôme Serrurier emphasizes. “Bosch has a deep knowledge of the Hüttlin coating technol-ogy, and our relations have always been very constructive and fair.” A second unit is currently being set up at Ferring’s Saint-Prex production plant – visible proof of the successful cooperation.


Peter Mérimèche

Phone: +49 7622 6884 201


The Hüttlin HKC 400 DJ fluid bed systen coats pharmaceutical granulates and provides shortened process and cleaning times, speeded up filling and discharging, and significantly reduced nitrogen consumption.


Almac provides a comprehensive product and services range extending from research through pharmaceutical and clinical development to commercializa-tion of products. The company is pri-vately owned, with its global headquar-ters in Northern Ireland, and has extensive facilities in the UK and the US. Employing approximately 3000 people, Almac serves a global network of over 600 companies. Half of Almac’s clinical supply business is primary and second-ary clinical packaging. Target customers

include the top multinational pharmaceu-tical manufacturers in the clinical trial supply industry down to smaller biotech companies. In order to analyze the effect of tablets, Almac needed a flexible and modular machine that is able to fill different tablets into capsules. At the same time, the capsules should be filled with powder and blended for clinical analyses. “Early in 2011 our operational team decided to expand our analytical capabil-ities,” says Dan Megill, Director of Opera-

tions at Almac. For that purpose, the facility in Souderton, Pennsylvania needed equipment for higher volumes. Almac’s new capsule filling line includes the newly designed GKF 702, a capsule deduster, a metal detector and the KKE 1700 checkweigher. The integration of the checkweigher ensures 100 percent control of filled capsules, with a feed-back loop from the checkweigher to the machine to determine if capsules are under- or overfilled. The KKE 1700 check-weigher comprehensively documents all production batches. “Our team toured Europe and looked at the different machines that vendors were offering. We determined very quickly that the Bosch equipment met all of our requirements. Out of all the options we evaluated, the Bosch machinery was the obvious choice,” Dan Megill explains. It is the first GKF 702 that Bosch has sold to the US market. “In the view of Bosch, the GKF 702 is probably a mid-output machine. For us it really stands for high volumes,” Megill adds.

A close collaborationThe GKF 702 builds on the success of its predecessor model, the GKF 701. With its upgraded performance, the machine

Providing flexibility for clinical purposesAlmac expands capacities with capsule filling line

In the middle of 2011, Bosch was appointed to deliver the capsule filling line to pharmaceutical services

supplier Almac. The company needed a flexible machine to support clinical supply. After a very short

implementation time of only a few months, the project was successfully concluded in the beginning of 2012.

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offers many advantages for research and development. In this particular project, the challenge was to fill capsules with different tablet sizes which were origi-nally not developed to be filled into cap-sules. Additionally, the time schedule for the project was very short. But the close collaboration of Bosch and Almac led to a successful conclusion. “The Bosch team helped us with their overall know-ledge base, which they have never stopped improving,” Dan Megill states. “They also gave our technicians and operators a very extensive training on the machine including trouble-shooting matters.”

“A real showpiece”Dan Megill sees the key benefits of the equipment in its tooling for filling and

easy-to-clean configuration. What is also special about the GKF 702 is its enor-mous flexibility. The machine is able to fill capsules not only with powders, pellets, tablets and liquids, but also with combinations. Its modular design offers the possibility to retrofit any filling needs and all new filling stations currently in development will be compatible with this type of machine. Small batches for research and development and clinical purposes can also be produced.Moreover, Bosch facilitates the process-ing of inhalable products via “micro-dosing”. A vacuum dosing wheel enables a gentle and accurate filling of very small quantities of powder. The filling weights can be easily adjusted during the set up phase and throughout the production process.

Dan Megill is most satisfied with the out-come of the project, “We have a real showpiece here. The customers who visit our facility are happy to see the new equipment available for their over-encap-sulation needs.” While Almac is ex panding its clinical packaging services, “further projects with Bosch may follow. Almac’s team is also examining Bosch’s cartoning machines,” Megill states.


Felix Nink

Phone: +49 711 811 57526


The GKF 702 offers enormous flexibility:The machine is able to fill capsules not only with powders, pellets, tablets and liquids, but also with combinations.


At present, every second disposable contact lens worldwide is

sterilized on an SBM machine from Bosch. More than 80 sterilizers

are currently in operation at several production sites with different

customers in Europe, Asia and the USA. Continuous improvements,

eye-level communication with the customers and technical support

have led to a machine availability of up to 99.9 percent.

Up to 99.9 percent availability

High machine uptimeBosch’s customer base includes leading producers of disposable contact lenses. Due to the complex nature of production and customers’ focus to meet their end users’ needs, top-quality processes are of paramount importance. This claim naturally also applies to the sterilization

equipment in use at the different sites around the globe. High flexibility and tight cooperation combined with process expertise make Bosch the preferred supplier of many contact lens producers. “The pioneering work accomplished in the development of the steam/air ster-ilization process additionally underpins

Bosch’s position in the market,” explains Alfred Kaliwoda, General Manager of SBM.The first cooperation between SBM and a contact lens producer started in the early nineties. Since that time, the machines have been developed continuously to fit the industry’s chang-ing needs. “Having Bosch support and service close to production sites around the globe proves to be a great advan-tage, as it helps to improve reaction time and simplifies logistics. Bosch equip-ment is constantly operating with the highest machine uptime while requiring the least maintenance within our entire processing line,” one of the customers emphasizes. This is underlined by the impressive figure of up to 99.9 percent availability of the sterilizers.

24/7 operations possibleThe production process for contact lenses is complex and must adhere to the strictest regulations for sterile medical devices. The sterilizers operate

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according to the steam/air mixture process. During sterilization at 121.1°C moist heat, all bacteria and germs are killed off within the packaging, achieving a Sterility Assurance Level (SAL) of six. Only one germ out of a million is allowed to survive. Therefore, stable processes and an even temperature distribution are crucial for successful sterilization. The product must not be damaged during the process and be removable in a dry condition.The contact lenses are packed into blis-ters. The sealed packages are sterilized in small but rather fast batches before being transported either manually or automatically to the cartoner. The major challenge for Bosch with one customer, for instance, was the design of a small and compact machine that could fit into a tight space. Bosch developed a steril-izer with an unusually small footprint of approximately one square meter. Despite the reduced space, automatic conveyor belts are integrated into the machine and controls are linked to and synchronized

with the lines. The lines can operate 24/7, while being extremely safe and reliable. Easy access for service and maintenance is also ensured.

Many more exciting projectsOver the years, quality and production requirements have grown continuously. They demand for reduced processing times and increased machinery uptime. Improvements on the component level are key factors of successful partner-ships in this area. Bosch is often required to integrate hardware and mechanical parts provided by their customers. “Our flexibility and the many small steps we take together make a great difference,” Alfred Kaliwoda comments.International customers of Bosch currently operate on over 80 SBM steril-izers from two generations. Only recently, factory acceptance tests (FAT) were carried out in SBM’s production facility in Ternitz, Austria. Four further sterilization units have been assembled

for new production lines and are intended to go into operation this year. “The way our customer relationships are evolving, we all can look forward to many more exciting projects,” Alfred Kaliwoda confirms.


Isa Alkan

Phone: +43 2630 312 214



Suzhou Beautycos International Co., Ltd., a subsidiary of L’Oréal, develops, produces and markets cosmetic and skin care products in China. The company is located in Suzhou, near Shanghai, in the East of the country. The city is criss-crossed by canals and therefore also known as the “Venice of the East”.

Well-established partnershipL’Oréal, with many well-known brands such as “Garnier,” “Elsève,” “Lancôme,” “Biotherm” and “Gemey Maybelline,” has put its trust in Bosch as a reliable supplier

of filling and capping machinery for many years. Recently, L’Oréal started produc-tion on another Bosch filling and capping line at its Beautycos International plant in Suzhou. The line consists of a linear piston filling machine FLK 7081 CIP Plus and a rotating servo capping machine VRM 6041 D as dual unit. The line handles a variety of face cream products with an output level of 120 jars per minute.

Flexibility for product range Beautycos International’s high standards apply not only to its own products but

also to the quality of packaging. Bosch Packaging Technology is a competent partner in meeting such high quality requirements. The Bosch piston filler achieves and ensures the required filling accuracy of 50 milliliters dosing quanti-ties for creams by using a ball manifold in combination with diaphragm valve technology. Proven Bosch technology, combined with a reproducible servo capping technique, guarantees screwing of the caps with precise torque values. A further requirement is met with processing an inlay lid at the first capping

Innovative skin care products from L’Oréal reliably filled to high quality standards

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station, while securing repeatable format changes with minimum changeover times.

Quality and hygieneHygiene and reproducible cleaning opera-tions are crucial considerations when selecting suitable filling systems for high-quality face care cosmetics. The Bosch piston filling machine with integrated CIP system (cleaning in place) allows all parts of the eight-head filling machine to be exposed and immersed in a free-flowing, defined combination of water and air. The piston filling machine meets hygienic re-quirements and microbiological standards in its closed-loop, inline cleaning process with defined temperature-time profiles (for example 80°C over ten minutes). After cleaning, the machine is cooled and production can be resumed.

User-friendly interface The integrated control system and operator interface features a choice of

languages (for instance Chinese, German and English) via touchscreen and allows the selection of all formats with secure and exactly repeatable settings. The operator interface delivers maximum flexibility and safety. All selectable func-tions can be protected from unauthorized access via different levels of passwords. If any problems occur, the system’s teleservice allows timely communication with the Bosch Service Center to avoid lengthy shutdowns.

Successful implementation As an experienced and technically accom-plished partner, Bosch saw Beautycos International’s high demands and expectations as a challenge, which was successfully met with the installation of a complete filling and capping line. Proven engineering, servo technology and the high flexibility of Bosch machines allowed for an optimal adaptation to highly demanding customer requirements.

Jörg Schmidt, principal coordinator of L’Oréal projects in South-East Asia, and the Beautycos International team opted for Bosch technology because it met the technical requirements of hygienic filling, as well as those of high efficiency and flexibility. Another decisive factor for the team to choose a reliable partner like Bosch was the ability to provide a quickly available, local service from its site in Hangzhou.

Bosch and Beautycos International – a successful team delivering top quality!

For more information please contact::

Kamel Meherzi

Phone: +49 2162 248 304


Avoiding downtimeSince the earliest days of production at their Luxembourg facility, Chemolux has systematically applied a Just-in-time (JiT) production strategy. “Rather than producing goods in advance, we focus on producing precisely the required amounts for exactly the time they are needed,” explains Philippe Gosset,

Plant Director at Chemolux. Benefits of this strategy include a decrease in over-production, shorter lead times and lower transport costs.JiT is an obvious solution for a company that has no dedicated storage space and can store no more than half a day’s production output. However, the strategy is not wholly without risk. Even minor

mechanical faults can quickly lead to unplanned downtime, forcing production to cease at very short notice. To mini-mize these risks, Chemolux and Bosch Packaging Services have developed a preventive maintenance strategy based on the results of a previous technical audit.


Maintenance with foresightTo improve the effectiveness of their production processes, Chemolux has introduced

a preventive maintenance strategy developed in partnership with Bosch Packaging Services.

Today the Luxembourg-based manufacturer of machine dishwashing powders and tabs

produces without unplanned downtime and with significant reduction in costs.

2006

Imp

rove

men

t

Machine efficiency

Legend: preventive maintenance improvement

Maintenance costs

2008

+13%

–11%

2011

packazine | 21

Optimized performanceIn a first step, the modernization of older equipment led to state-of-the-art technology being introduced on all lines. In a second step, a dedicated preventive maintenance program was implemented resulting in long-term sustainable improvements. “Chemolux operates in a very dynamic market, products are changing fast. For this reason, high flex-ibility and continuous improvement of our production processes are absolutely crucial,” says Ludovic Ghesquière, Maintenance Manager at Chemolux.The aggressive chemical production environment and high operational speed of all machines, throughout several shifts per day, necessitate frequent exchange of wear and tear parts and short main-tenance intervals. Bosch’s preventive maintenance service package ensures that required maintenance is conducted at the appropriate time and at regular intervals, on all 15 lines.

Small intervals, huge effectThe biggest challenge at Chemolux con-sisted in finding the right maintenance

intervals for all lines and implementing the new maintenance concept within the organization. The fact that both companies had successfully worked together for 15 years and that Bosch Packaging Services already had an intimate knowledge of Chemolux’s business processes proved to be a great advantage for both sides. Following an intensive implementation phase, first positive results became visible. “No major stops have occurred during the past five years,” says Phillippe Gosset. “In addition, maintenance costs have decreased and efficiency has increased by a two-digit percentage.”The machines are checked and cleaned per shift, day, week or month, depending on the requirements of the individual lines. “Thanks to the scheduled intervals, we have complete control over our lines and can deliver a high level of service for our customers,” Ludovic Ghesquière observes. The organization of mainte-nance activities is now much smoother and more predictable, resulting in reduced costs. A detailed evaluation of the Preventive Maintenance program

demonstrated an 11 percent decrease in costs between 2008 and 2011, while machine efficiency increased by 13 percent during the same period.

Collaboration based on partnershipThe establishment of the Preventive Maintenance program also had the positive side-effect of intensifying the relationship between Chemolux and Bosch. Regular inspections are always carried out by the same Bosch maintenance technicians with Chemolux-specific expertise. “Today, we achieve faster product changeovers and have real experts working on our machines,” says Philippe Gosset, to which Ludovic Ghesquière adds: “Our goal was to switch from a customer-supplier relationship to a real partnership – and we have achieved this to our complete satisfaction.”


Claudio Manfroni

Phone: +41 58 674 73 98


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