packazine · insulin manufacturers in turn must pay particular attention to a comparatively...

packazinePharma · Issue 2014

Serum Institute | High-quality vaccines for everyone Novartis | Customized system for highest flexibility

2 | packazine Table of contents | Editorial

www.boschpackaging.com [email protected]

News

Facts & Trends04 Diabetes | Fighting a global pandemic

Customers & Markets

Pharma07 Laboratorios Normon | New fluid bed system triples batch sizes

10 Siemens & Co. | Modified thermoforming line for packaging of „Emser pastilles“

13 Serum Institute | Affordable, high-quality vaccines for everyone

16 Excelvision | Keeping an eye on automation

18 Novartis | Bosch supplies flexible filling and packaging line for pharmaceuticals

21 Allergy Labs | Peristaltic pump put to the test

24 Cipla | Flexible solutions for complex formulations

Events

26 Events 2014

CoverWith a fully automated packaging line

Excelvision accelerated production with help from Bosch.

10 16

Table of contents

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Dear readers,

This year, the focus of all our efforts at Bosch Packaging Technology is on Interpack 2014, the world’s biggest packaging technology trade fair. Back at the very first Interpack in 1958, the former companies Hamac Packmaschinen and Hansella-Maschinen (later Hamac-Hansella), Hesser, Höller,

Magrolo-Maschinen (later Makat), Sapal and SIG’s packaging sector (later SIG pack) from the food and confectionery sector as well as the pharmaceutical packaging machinery manufacturers Höfliger & Karg and Strunck presented their machines. These companies today have become part of the Bosch family, making Bosch Packaging Technology unite more than 150 years of packaging know-how under one umbrella. We will keep with the tradition of Interpack participation this year, too, by using the show as a platform to pre-sent you our latest innovations and proven portfolio on almost 3000 square meters of booth space.

The entire packaging machinery industry is in a time of change, the defining trends of which are still ever stricter regulations on production hygiene, constantly changing consumer requirements, and the imperative to cut costs. We at Bosch Packaging Technology are determined not simply to react to these changes, but to play an active part in shaping them.As we work to develop our innovations, we always have your needs as a producer in mind. Come to Interpack and be inspired by the equipment that Bosch can offer, which will give you the flexibility to react quickly to changes in the marketplace and help you to meet hygiene regulations. Our equip-ment is designed to support fast changeover times, quick and thorough cleaning, and simple opera-tion – all of which increases the efficiency of your production process. In addition, we are there to provide you with advice and tailor the best solution for your specific requirements: That might involve an upgrade to existing machinery, partial automation of your production line or it could mean a complete, seamlessly integrated system, that covers not just the production of bars, say, but also primary, secondary, and end-of-line packaging. We are also there for you once your equipment is in operation, offering you a range of services that includes everything from maintenance to training.Our 2013 financial results show that we are on the right track with this strategy. I would like to take this opportunity to thank you, our customers, for these excellent results. It is the trust that you con-tinue to put in us, along with the ideas that emerge from our everyday work together, that motivate us and spur us on to be innovative. The success stories gathered here in the 2014 packazine will give you a taste of the successful collaboration. Yogurt, cookies, lozenges or vaccines – Packaged as promised. Bosch.

I hope you enjoy reading the new packazine.

Friedbert Klefenz

18 21

Friedbert KlefenzPresident,

Bosch Packaging Technology

Editorial

4 | packazine News Facts & Trends

In type 1 diabetes, the body’s own im-mune cells are directed against the insu-lin-producing beta cells of the islets of Langerhans in the pancreas, often al-ready in childhood. The resulting insulin deficiency always requires insulin ther-apy. Type 2 diabetes today accounts for about 90 percent of all cases. Obesity and lack of exercise lead to a resistance to the insulin hormone, preventing it from working properly on the cell mem-branes and from transporting glucose into the cells. The result is increased blood glucose concentration, which of-ten goes unrecognized for many years.

Changing diabetes therapiesAll approaches to diabetes therapy have always been aimed at controlling blood sugar levels and preventing large fluctua-tions down (hypoglycemia) or up (hyper-glycemia). Today, insulin is obtained

Diabetes mellitus is the first non-infectious disease that has taken on the magnitude

of a pandemic. It is estimated that the number will increase from 382 to 592 million

people with diabetes by 2035. Nevertheless, diabetes research has made great progress

in recent years. The once deadly disease has become one that is chronic.

New, targeted therapies and application technologies for insulin administration have

given back some flexibility in everyday life to patients.

Diabetes Care: fighting a global pandemic

packazine | 5

from bacteria using biotech methods and brought to the market as human insulin. A very significant progress was domestic self-monitoring of blood glucose in the 1980s. Further milestones include the approval of so-called insulin analogs, that work particularly quickly or uniformly, as well as insulin pumps, which continu-ously and flexibly provide diabetes type 1 patients with short-acting insulin.Moreover, insulin pens were developed for more ease of delivery. They are used as multiple application systems with pre-filled insulin cartridges. For diabetes patients, the independent administra-tion of insulin is now a lot easier. Due to their shape, the pens can not only be transported more conveniently, they can also be applied “en route” without at-tracting attention. Patients are able to better adapt the therapy to their own rhythm of life.

Focus on safety and output Pens are currently the most widely used system for insulin injection. For diabetes patients, easy and safe handling of the pens is the most important criterion. Insulin manufacturers in turn must pay particular attention to a comparatively inexpensive production, sterile filling and the integrity of the materials used by reducing manual intervention during the production process as much as pos-sible. Modern barrier technology com-pletely seals off products, processes, equipment and operators from each other. Insulin manufacturers also in-creasingly rely on the use of isolators, which ensure higher product quality at lower cost compared to conventional cleanrooms.In addition to the omnipresent cost fac-tor, the growing number of diabetes pa-tients in the emerging economies has

driven the use of machines for the pro-cessing of cartridges for insulin pens particularly in the so-called “pharmerg-ing” markets. The criteria by which manu facturers choose their machines are high output, high availability, and reproducible precision in insulin produc-tion. Filling and closing machines for car-tridges with a capacity of up to 600 units per minute are now considered state-of-the-art. Modern plants and lines are compatible with all current filling tech-nologies and partly also equipped with combi filling stations for different drug requirement and packaging types.

Passing all processes unscathedIn all process steps, the cartridge is exposed to different temperatures, pres-sures, and movements. The higher the speed of a filling and closing machine, the more the glass is exposed to physi-

6 | packazine News Facts & Trends

cal stress. This can cause damage to the glass, such as cracks, chips, or fractures. These defects result in product loss and higher costs for pharmaceutical produc-ers, which machine manufacturers are counteracting with new solutions for gentle processing. The primary objective is hence to minimize contact between glass containers.During loading of the cleaning machine, for instance, the cartridges are trans-ported in so-called transport pucks in a row to prevent glass-to-glass contact. During the sterilization process, the glass is exposed to an enormous heat influence, leading to the expansion of the glass mass. This can be compensated by a con-veyor belt with flexible lateral support, which widens immediately after the tun-nel entrance. To protect the cartridges from damage from tipping over, they are transported to the inlet of the filling ma-chine in bulk, where a star wheel sepa-rates them again. Robotic feeding and re-moval of cartridges can provide further reduction in physical stress.

Precise filling and inspectionFor a full and bubble-free filling 80 per-cent of the maximum quantity is dosed into the cartridge before the remainder is filled to the full point by laser-scanning the cartridge neck. The laser sensor switches off the dosing when the fluid meniscus reaches the laser beam. 100-percent inspection plays an impor-tant role for the exact closure of the car-tridges. With the “Static Division” (SD) technology, light is projected through the liquid onto an optical sensor, which allows differentiation between moving particles and static objects, for instance inhomogeneity in the glass packaging. Automatic camera-based systems in turn detect both particles and cosmetic defects.Even at an early developmental stage of insulin preparations, safe filling of car-tridges with manual and semi-automated test machines has priority. It is particu-larly important that these machines can be equipped with different filling tech-nologies and allow the filling parameters

to be easily transferred to production systems via scale-up. Inspection is equally important: empty and full glass containers can be quickly and accurately inspected for particles in the liquid or for cosmetic defects.

Significantly improved quality of lifeIt is still uncertain when alternatives to injecting insulin will prevail. But the near future already promises the introduction of further insulin formulations and new, improved insulin pens. Although preven-tion and avoidance of long-term conse-quences must always be top priority, advances in treatment provide people affected by diabetes with the hope of further, significant improvement in their quality of life.

For more information please contact:

Dr. Johannes Rauschnabel

Phone: +49 7951 402 452

E-mail: [email protected]

A key milestone in diabetes therapies: application technologies like insulin pumps and pens

packazine | 7packazine | 7

With more than 75 years of experience on the Spanish market, Normon is among the leading pharmaceutical manu-facturers in the country. What started as a small family business in 1937 has ex-panded into a corporation that now em-ploys around 1400 people who share a production space of 80 000 square me-ters. More than 90 percent of the pro-duction outcome consists of generic drugs. The production site accommo-dates machines for manufacturing liquid vials, freeze-dried vials, dental cartridges, ampoules or infusion bags, as well as for granules, capsules, and tablets including

products such as antibiotics, high poten-cy products, anesthetics, analgesics and anti-inflammatories, which are distribut-ed worldwide.

Based on solid experienceWith the aim of reducing costs, Normon planned to significantly increase its batch sizes for certain products. The manufacturer needed to pay close atten-tion to the high quality and safety stan-dards and economic aspects, as well as flexible production sizes and times. This required the use of flexible and reliable technology, and resulted in a renewed

cooperation with long-term partner Hüttlin GmbH, located in Schopfheim, Germany. Hüttlin has been part of Bosch Packaging Technology since 2011. Together with the Bosch brand Manesty, Hüttlin completes Bosch’s process tech-nology portfolio for pharmaceuticals. From development to production ma-chinery, all Hüttlin systems are designed to meet customer and market require-ments. The portfolio covers equipment for mixing, granulating, drying and coat-ing, as well as comprehensive contain-ment solutions and laboratory installa-tions.

Full speed ahead for NormonNew Hüttlin fluid bed system HDGC 600 triples batch sizes for

Laboratorios Normon while significantly reducing costs

8 | packazine Customers & Markets Pharma

Normon already installed two fluid bed systems HDG 200 in 2004 and two further ones in 2008. “For many years, Hüttlin has provided us with excellent quality machinery. So the decision to purchase an additional Hüttlin fluid bed system was based on solid experience,” says Gonzalo Fernández Govantes, re-sponsible for Technical Operations and Industrial Processes at Laboratorios Normon, S.A. “It quickly showed that the HDGC 600 offered the specific life sci-ence functionality we wanted, backed by the robust technology we needed. Normon also required a system which provides the highest possible perfor-mance, reliability and functionality, while giving us the flexibility to quickly make changes to our processes. We wanted to give our production a tool that moves us to the front of the technology race,” Gonzalo Fernández Govantes adds.

Tripling batch sizes with the Hüttlin HDGC 600The Hüttlin fluid bed systems are based on a modular design. They can easily be configured either as dryer (HD), dryer granulator (HDG) or dryer granulator coater (HDGC). Therefore, the process steps of drying, granulating and coating of fine particles, powders and pellets can be realized with one machine and one single product container. Before im-plementing the Hüttlin HDGC 600 at its production facility in Madrid, Normon carried out its granulation processes on several smaller Hüttlin fluid bed systems. While Normon still uses these machines for certain products and smaller batch sizes, operations for larger batches are much more efficient now with a machine at higher production capacity. Today Normon only needs half the time to pro-

duce the same amount of product. In-cluding documentation time, the produc-tion of three batches on the HDG 200 amounted to 20 hours. By tripling the batch size on the new HDGC 600, the production of only one batch now suf-fices to significantly save time and costs. Moreover, the bottom-spray technology of the HDGC 600 with the air distri-bution plate Hüttlin Diskjet and the 12 three-component spray nozzles en-sure fast and uniform mixing, high spray rates, shorter drying periods and even spray distribution as well as a minimum of spray losses. “Since we tripled batch sizes, we have been able to reduce docu-mentation, the number of quality control analyses as well as working hours and energy consumption, and ultimately have reduced process times of up to 30 per-cent,” Gonzalo Fernández Govantes confirms. The HDGC 600 satisfies all Normon’s key requirements. The company is able to mix products with different densities in one single process container. Operators

can simply select a new functionality such as the coating process. All recipes from laboratory equipment can be easily scaled-up to both the HDG 200 and the new HDGC 600. Gonzalo Fernández Govantes confirms, “Our staff has been working with Hüttlin processing ma-chines for ten years and has been trained on the equipment. So we can realize changes without any additional costs.” Homogenous drying results, the omis-sion of dead zones in the product bowl and preventing the product from sticking and clogging to the walls are further benefits for Normon.

Smooth implementationIt took less than twelve months from project kick-off until the HDGC 600 went into production. According to Normon’s Gonzalo Fernández Govantes, “The Hüttlin service team was constantly on-site to ensure a smooth implementation.” After carrying out first on-site tests, the Bosch team remained in place to accom-pany the first production batches.

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Normon produces more than ten differ-ent products on the new fluid bed system. Some new products have al-ready been approved by the Spanish Agency of Medicines and Medical De-vices (AEMPS). Normon is set to launch new generics, and its development teams are preparing most of these prod-ucts in the Hüttlin laboratory equipment. This equipment documents and controls product development processes and makes it easy to get a quick authoriza-tion for production batches. “We are planning to build a new area for oral dosage forms in the following years, and we are expanding all of our manufactur-ing areas such as cytotoxics, hospital or dental products. For the preparation and roll-out of our new generics, we need a reliable long-term partner to support our processes,” Gonzalo Fernández Govantes underlines. “Oper-ating the Hüttlin HDGC 600, we can go full speed ahead in manufacturing ge-nerics and defend our position as one of the leading pharmaceutical manufactur-ers in Spain.”


Dolf Oberborbeck

Phone: +49 7622 6884 212


packazine | 11

Packaging line revamped

Even the most durable packaging ma-chine will need spare parts sooner or later. But what is to be done if the neces-sary electronic components are no longer available? Equipment manufacturers are required to inform their customers about available technologies and modification opportunities in good time to prevent machine downtime and production loss. This also applied to the German company Siemens & Co. in Bad Ems who produces the well-known “Emser pastilles”. Bosch Packaging Services modified the compa-ny’s TLT 1400 thermoforming machine within a very short time by equipping it with new servo motors, servo controllers and a new control system.Siemens & Co., based in Bad Ems, Ger-many, was founded in 1958 and has been operating as a family-run company since 1998. It produces salt products for treat-ing the upper respiratory tracts, espe-cially the nose and throat. The mineral,

which contains high levels of trace ele-ments, is obtained by vaporizing water from a hot mineral spring in Bad Ems. It is offered in several dosage forms, such as saline nasal douches, nasal spray and drops, developed to ease chronic infec-tions and dry mucosae. The Emser pas-tilles are solely available in pharmacies in five different flavors and help to moistur-ize and clean strained pharyngeal muco-sae caused by coughing and hoarseness.

“Obsolete spare parts”For generations, Siemens & Co. has been relying on technical equipment from Bosch Packaging Technology to pack its different salt products. For instance, the company fills its powdery saline nasal douches on a high-performance stick pack line at rates of up to 1000 packs per minute. For the Emser pastilles, Siemens & Co. uses a Bosch packaging line con-sisting of a TLT 1400 thermoforming ma-

chine, a CUT 120 cartoner and a KWE 3000 checkweigher. With an output of up to 250 blisters per minute, the TLT 1400 processes the pastilles before they are packed into folding boxes and weighed. The line’s centerpiece consists of the TLT 1400 thermoforming machine, which is characterized by its flexibility, usability, safety and high Overall Equipment Effec-tiveness (OEE). A color touchscreen fa-cilitates the machine’s operation; format parts for different packaging sizes can be quickly changed, almost without the use of tools.The original servo motors of the TLT 1400 belonged to an older generation that is no longer being produced. This is a mat-ter of so-called “obsolete spare parts” – parts and components from third party providers that are outdated or no longer available. “Many customers need new components for their machines at short notice. Only then do they realize that

Bosch Packaging Services modifies thermoforming line

for packaging of “Emser pastilles”


certain spare parts are no longer state-of-the-art or out of stock. So it is all the more important to actively inform them about the availability beforehand and to offer adequate solutions. Due to the rapid pace of technological development,electronic components unfortunately of-ten have a short lifespan and are no lon-ger available after only a few years,” ex-plains Andreas Herrmann, service sales manager at Bosch Packaging Services. With customer letters and so-called up-grade letters published on the E-Portal,the online ordering platform for spare parts, Bosch Packaging Services regu-larly informs customers about the avail-ability of components and suggests mea-sures for preventive modifications and maintenance.

Modification in only half the time“For ten years we have been reliably blis-tering our pastilles on Bosch’s thermo-forming machine,” reports Dr. Andreas Keller, operations manager at Siemens & Co. “We don’t have a second thermo-forming machine at our disposal andmust be able to fully rely on this one ma-chine. So we faced a considerable chal-lenge when a servo motor broke down.”

Quick support was required, as not onlythe servo motors but also all motor con-trol units and the control system needed replacing. “Bosch Packaging Services helped us to bridge the time gap until the modifica-tion with as little production loss as pos-sible,” Dr. Andreas Keller recalls. “The modification itself progressed consider-ably quicker than expected.” Instead of taking the estimated eight weeks, the ex-perienced Bosch technicians managed to carry out the entire modification projectin half the time. After only four weeks, the TLT 1400 was equipped with a new motor, control and operation technology, and was extensively documented and val-idated. Moreover, the machine obtained a more powerful computer with newsoftware. To the customer’s completesatisfaction, the calculated costs were also reduced by 30 percent.

Quick resumption of productionPerformance tests, machine qualification and validation completed the upgrade process. “Our customer now has a ma-chine on-site which is equipped with thelatest drive and control technology. We had to make sure that it runs as smoothly

and can be operated as reliably as be-fore,” explains Hans-Jürgen Meisel, service engineer at Bosch Packaging Services. Together with the customer, he tested the motor and control technologyof the modified TLT 1400 in detail, based on the validation protocols. As soon as the last fine tuning was completed, andsmooth operation of the line was en-sured, Siemens & Co. resumed produc-tion of the pastilles on their TLT 1400. “We would carry out another machine

modification with Bosch Packaging Ser-vices at any time. The technicians are very familiar with the equipment. They planned the modification of our blister line in a competent manner and quickly put it into practice,” Dr. Andreas Keller confirms. Physically unchanged, the TLT 1400 in Bad Ems runs as reliably as before. “We were able to resume the packaging of our Emser pastilles in avery short time – and are now hoping for a renewed long lifespan of our TLT 1400,” Dr. Keller concludes.


Andreas Herrmann

Phone: +49 711 811 57068


The Indian vaccine manufacturer Serum Institute of India has a vision – to contin-ually increase the production of afford-able, high-quality vaccines. The founder and owner Dr. Cyrus S. Poonawalla be-lieves that every child in the world should be granted access to inexpensive bacterial and viral vaccines. Numerous humanitarian organizations and inter-national celebrities accompany Dr. Poonawalla and his colleagues on their charitable journey. In daily production business, they rely on first-class machin-ery from Bosch Packaging Technology.Dr. Cyrus S. Poonawalla is a role model for many and well-known way beyond the Indian borders. He has been

awarded many prizes; a school in Pune bears his name. But his most important lifetime achievement, Serum Institute of India Ltd., was established back in 1966 with the aim of manufacturing affordable life-saving immuno-biologics for the entire population. After attending col-lege, Dr. Poonawalla, who is also a dedi-cated and well-known horse breeder in India, began manufacturing antitoxins at affordable prices, without making any compromises on quality. During this time, these vital preventive medicines were scarcely available and far too ex-pensive for the majority of the Indian population – with the devastating result of many children dying needlessly.

Dr. Poonawalla tackled this issue and has done so ever since with passion, dedication and perfection. “He has a very strong philanthropic character and through his hard work he is leading the company by his own example,” says Dr. S. D. Ravetkar, executive director, Serum Institute of India.

Joint humanitarian forcesToday Serum Institute is India’s leading biotech company and one of the largest manufacturers of vaccines in the world with a huge capacity of billions of differ-ent vaccine doses annually. Reaching out to more than 140 countries, it is estimated that every second child

packazine | 13

Affordable, high-quality vaccines for everyone

Serum Institute of India manufactures life-saving vaccines

on Bosch filling lines

immunized receives at least one vaccine produced by Serum Institute. Even newer vaccines, such as the five-in-one pentavalent (Penta) vaccine and anti-ra-bies vaccines, can now be offered at af-fordable prices to children around the world. The manufacturer aims at target-ing more countries every year.

The company is the first across Asia to be qualified by the World Health Organi-zation (WHO); it supplies its products to the United Nations Children’s Fund (UNICEF) and the Pan American Health Organization (PAHO). Serum Institute is proud of the relationships with celebri-ties and fellow philanthropists including

Bill Gates and Prince Charles. In collabo-ration with the Bill & Melinda Gates-funded Meningitis Vaccine Project, a partnership between WHO and the inter-national non-profit organization PATH, Serum Institute produced the new Men-ingitis vaccine MenAfriVac for the African market at only 50 cents per dose.


Bosch’s filling and closing machinery for vials, ampoules and syringes help Dr. Poonawallas vision to become reality: supplying affordable vaccines to all children around the world.

Dr. Poonawalla’s charitable drive has influenced other dominant players within the industry to follow his good example and will not stop until all vaccines are affordable for the entire world popula-tion.

Reliability, quality and durabilityThe Serum Bio Pharma Park in Pune is the first of its kind in the country and was designed in strict compliance with cGMP (current Good Manufacturing Practice) standards. It serves as the re-search, development and production base for Serum Institute. “Needless to say, such a modern facility must be equipped with highly reliable and state-of-the-art machines,” Dr. Ravetkar ex-plains. “Bosch is renowned for its high quality all over the world. I have been in this business for many years and have always dreamt of having a Bosch line in our facility.” Ten years ago, the first joint project marked the beginning of a long and trustful relationship. The contact between Serum Institute and Bosch has always been very open and personal. Dr. Ravetkar and Friedbert Klefenz, President of Bosch Packaging Technology, already knew each other long before the start of the business cooperation.Serum Institute of India must be able to fully rely on a highly innovative manufac-turer and requires high-quality machin-ery, which is of paramount importance for the safe filling and closing of life-sav-ing vaccines. To date Serum Institute has installed five Bosch lines in Pune. More specifically, the company handles vials on an FLC, an FLP and an FLM filling and closing line; ampoules and vials are filled and sealed on an ALF combi line, freeze-dry vials are crimped on a stand alone vial capper VRK, all of which were manu-factured at the Bosch Packaging Technol-

ogy location Crailsheim, Germany. An additional FXS 2020 filling and closing line for pre-sterilized nested syringes was brought to Pune from Bosch in China.

Small things do matterThe latest project, a new FLC vial line from Crailsheim, is set to be installed in the next few months. The lines are used for various groups of vaccines, such as vaccines for MMR and Penta vaccines. Apart from the high quality, Dr. Ravetkar identified further benefits, ranging from a high durability and reliability to profes-sional service around the clock. “All members of Bosch are dedicated to walk the extra mile,” he emphasizes. “Repre-sentatives from India and Germany regu-larly visit Serum Institute. Many up-front meetings were dedicated to discussing our needs.”To obtain the best possible machine out-put, Serum Institute and Bosch continu-ously work on slight adaptations to the

lines. “Bosch appreciates our feedback and is eager to learn from our experi-ence,” says Dr. Ravetkar. “Often it’s the small things that make a big difference, for instance easy documentation and validation processes and small features that make life easier for our machine operators. With every project, the lines are adapted even better to our require-ments.” The filling and closing lines from Bosch have supported Serum Institute in coming a step closer to completing Dr. Poonawalla’s mission of supplying affordable vaccines to all children around the world. “Bosch is one of the only companies who can truly act as a full-range supplier. I believe that every company should own a line developed by Bosch,” Dr. Ravetkar concludes.


Dieter Bandtel

Phone: +49 7951 402 362


packazine | 15packazine | 15packazine | 15

Dr. Cyrus S. Poonawalla, founder of the institute


Specializing in sterile manufacturing, Excelvision, based in Annonay, France, provides contract manufacturing services for liquid eye drop plastic vials to numer-ous companies. However, to increase production and capitalize on additional contract manufacturing opportunities, Excelvision enlisted Bosch Packaging Systems AG, based in Beringen, Switzer-land, to install a fully automated packag-ing line. With significantly higher output capabilities, Excelvision expects to increase production by nearly five-fold. Excelvision manufactures vial cards in bulk, each hold five blow-fill-sealed single-use vials. Because the company produces different product shapes and configurations for its customers, it faced a logistical challenge in rapidly packaging the diverse products. Prior to working with Bosch, Excelvision’s previous solution was unable to keep up with current demand, let alone plan for

new market expansion. Purchasing mul-tiple storage trays dedicated to each product format size would have been too costly. However, Bosch’s complete line solution allowed the company to use one storage tray type for all product formats.

One trusted relationshipHaving previously used stand-alone ma-chines Pierre Laissy, project manager at Excelvision explains, “Bosch provided the consultation we needed for a suc-cessful upgrade to our first highly auto-mated, complete line solution.” The project also involved a lengthy approval process with Excelvision’s customers as they needed to verify that the new pack-aging solution would meet market needs and regulations. During this vetting pro-cess, Bosch regularly consulted with Excelvision about different packaging styles and materials.

To meet different customer needs, Excel-vision required equipment that could be easily adapted for specific demands. “As demand increases for single-dosage packaging, the new line gives us the flex-ibility to adapt production in the future,” adds Philippe Pensuet, head of engi-neering and EHS at Excelvision.

Flexibility from primary to secondary The bulk vial cards are first manually loaded into an intelligent feeding unit, which unscrambles and separates them equidistantly. The vial cards then travel to the Sigpack LDF feed placer, which features delta robots that pick and place individual cards into an infeed wrapper chain. The module is equipped with a vision detection system that ensures quality control of the products. It also communicates with the robot picker to ensure correct product orientation. Products then move along to the Bosch Sigpack HSL horizontal flow wrapper, which features a long dwell sealing unit for extended sealing time. This ensures that the aluminum-laminated film is her-metically sealed, which is critical to pro-tecting the blow-fill-sealed products against water evaporation and light ef-fects. Bosch also subjected the wrapped cards to various tests, such as vacuum pressure and under water submersion, to verify that packs have an air-tight seal.For cartoning Excelvision installed Bosch’s Sigpack TTM topload cartoner, which picks flow-wrapped products out of a grouping chain and places them into cartons. A key advantage of the Sigpack TTM is the ability to make quick and

Keeping an eye on automationHow an eye drop manufacturer accelerated production with

help from Bosch

packazine | 17

tool-less changeovers for up to four dif-ferent carton formats, giving Excelvision the flexibility to accommodate diverse customer needs. The Sigpack TTM is equipped with a leaflet carousel feeder to place information booklets into the cartons

before they are closed. In addition, the cartons have a tamper-evident feature, making it easy for retailers and consum-ers to spot packages that have been opened. Bosch performed performance and film tests to demonstrate the feasibility of

the solution, every quality-relevant step of the way during the process.


René Kummer

Phone: +41 58 674 6776


The vial cards are hermetically sealed in aluminum-laminated film to protect them against light effects and water evaporation.


The medicine of the ancient Egypt is one of the oldest documented and has signif-icantly influenced today’s medical prac-tice. Since then, medicine has evolved dramatically, but Swiss pharmaceutical giant Novartis has been producing and filling a wide range of pharmaceuticals from Egypt for more than 50 years.

From Switzerland to Egypt and beyondHeadquartered in Basel, Switzerland, Novartis is one of the largest pharmaceu-tical manufacturers worldwide. It was es-tablished in 1996 as the result of the

merger of Ciba-Geigy and Sandoz. The company’s top-selling brands include Glivec to treat certain types of leukemia, Diovan to treat high blood pressure and heart failure, and Lucentis to treat eye maladies.The Novartis plant in Cairo, Egypt pro-duces enough medication to meet seven percent of the country’s market needs and serves as a base for the manufactur-ing and supply chain management of pre-scription pharmaceuticals, as well as over-the-counter (OTC) products. The Cairo facility meets the highest Health,

Safety and Environment (HSE) standards, complying with ISO 14001 and OHSAS 18001, as well as receiving Novartis’ own internal HSE award 12 years in a row.

Three in oneHowever, the facility met its match trying to fill and package 15 milliliter plastic bottles of Otrivin Saline Baby nose drops, 10 milliliter plastic bottles of Otrivin nasal spray and 100 milliliter glass bottles of Catafly Suspension cough syrup. Varying consistencies from oily nose spray and drops to sticky cough

Novartis producing from the birth

Bosch supplies flexible filling and packaging line for pharmaceuticals

for Novartis in Egypt

packazine | 19

syrup presented one hurdle. The differ-ent packaging formats presented another – particularly since these require differ-ent types of closures. While a screw cap and measuring cup are necessary for the cough syrup, an insert and screw cap for nasal drops and spray pump with screw cap are needed for nasal spray. Novartis needed a solution that is highly flexible and easy to clean during change-overs between products. Novartis en-listed Bosch Packaging Technology, a leading provider of packaging solutions for the pharmaceutical industry. “We

were impressed by the flexibility of the company’s equipment and confident that Bosch had the capabilities to produce a single-line solution for these three prod-ucts,” says Mohamed Galal, project man-ager at Novartis in Egypt.

Lean and clean Bosch customized the line that met Novartis’ criteria, starting with a bottle unscrambler, followed by an air blower to clean inside all three bottles and prevent particle contamination. To clean the plastic bottles, each blowing nozzle

ionizes the blowing air, which neutralizes the electrostatic loads on the inner sur-face of the bottles and facilitates easy foreign particle removal. Because this function is not needed for glass bottles, it can be switched off easily during pro-duction. The bottles then move into a lin-ear piston filling machine equipped with ten nitrogen pre-flushing nozzles and ten fill nozzles. Nitrogen flushing reduces the oxygen content in pharmaceutical prod-ucts to prevent oxidation after capping. To allow for format flexibility, the line incorporates three different rotary

place of western medicine

capping machines, which are used de-pending on the product. The first is de-signed to equip each nose spray bottle with a pump. The second rotary capping machine applies the plug to the nose drop bottles. The third capper is used for all formats: screwing of all three dif-ferent caps on each bottle and placing the measuring cap on the 100 milliliter glass bottle. A key function of the line is the Cleaning-in-Place (CIP) Plus-system, which en-sures repeatable cleaning results. Clean-ing must be done after every product. From filling to capping, the line is fully covered by a laminar flow hood that leverages overpressure to prevent any intrusion of foreign particles.After the capping process the bottles are conveyed to the labeling system, with the exception of the pre-printed nasal spray bottles. For secondary packaging, the bottles are fed into the continuous motion cartoning machine CUK from

Bosch, which is the ideal solution to ful-fill Novartis requirements in format flexi-bility, short changeover times and less maintenance. Novartis runs a total of 15 different format options for product, car-tons and leaflets sizes, which the Bosch CUK can easily set in a short time. The cartoner’s “swing open” leaflet feeder allows for the operator to quickly ensure that leaflets are correctly in place without a second person helping from the machine rear. Feeding of leaflets and carton blanks are located closely to one another, further simplifying the opera-tor’s work. All cartons are positively opened by a “counter” suction head that forms the flat cartons into three-dimen-sional shapes and eliminates “dead” cartons that failed to unfold. This results in the safe handling of critical carton qualities, no material or product loss, and decreased production downtime. In addition, all leaflets are carried in mechanical grippers that reliably place

them into the cartons. These are only some out of many functions that reduce machine stops to a minimum and there-fore, contribute to higher uptime.

Flexibility, speed and energy efficiency yield resultsNot only did Bosch’s customized system for Novartis help the company streamline the filling and packaging of three differ-ent products with different packaging formats, it also enhanced production speed from a rate of 100 bottles to 140 bottles per minute for sizes of 10 and 15 milliliter. For 100 milliliter bottles, speed increased to 120 bottles per min-ute. The equipment also improved energy savings by US$ 60 000 annually with its advances to the bottle cleaning process.


Kamel Meherzi

Phone: +49 2162 248 304



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Allergy Laboratories, Inc. was estab-lished in 1929 in Oklahoma City for the manufacture of allergenic extracts needed to support the growing immuno-therapy practice of founder Dr. Raymond Balyeat. Allergy Labs, as the company is more widely known, has since evolved into an FDA-licensed pharmaceutical manufacturer of over 500 different bio-logical extracts for the diagnostic testing and therapeutic treatment of allergies. Additional manufacturing and supply capabilities have been added over the

years, including a parenteral production facility for contract manufacturing. The company is dedicated to high quality, strictly controlled manufacturing prac-tices, affordable products and excellent customer service. Allergy Labs applies this dedication to the manufacturing of sterile depyrogenated vials, sterile dilu-ent and injectable drugs.

Compact and cleanIn 2010, Allergy Labs turned to Bosch to acquire a new filling and closing ma chine

for vials and infusion bottles. To satisfy the company’s needs, two main require-ments had to be fulfilled: first, the line needed to operate with peristaltic pump technology; second, it had to fit exactly into the space that had become avail-able by discarding an old machine. “We work with piston pump technology on another line, which can lead to cleaning and maintenance difficulties,” says Lee Beaver, director of manufacturing at Allergy Laboratories, Inc. “So we started looking for a filling and closing machine

Peristaltic pump put to the test

When it comes to the filling of liquid pharmaceuticals, peristaltic pumps have

become more and more popular over recent years. While primarily used for

developmental purposes, this technology today offers a safe, clean and flexible

alternative to conventional filling systems. Allergy Laboratories, Inc. has been

successfully working with this technology for just over two years, and reflects on

some very positive user experiences.

that operates with peristaltic pump technology. We checked the market, and Bosch has a good reputation for this kind of technology. The open communi-cation and expertise of our contacts at Bosch facilitated our decision. They were always quick in responding to our queries and requests, which enabled a quick turnaround time for the project.”

The equipment was manufactured on the site of Bosch Packaging Technology in Minneapolis and was installed by an expert engineering team from Bosch.

Traditional concept revisitedSix years ago, Bosch started to develop its own peristaltic pumps to supply the growing needs of its pharmaceutical

customers. While peristaltic pumps were previously used for the development of small pharmaceutical batches, they now offer a real alternative to conventional filling systems. The Bosch peristaltic pump combines the advantages of the traditional peristaltic concept with opti-mized dosing accuracy and a very flexi-ble operating concept. The new tubing


concept of Bosch’s peristaltic pump makes the technology suitable for all kinds of filling operations, from develop-ment purposes to production-scale fill-ing operations. The offset alignment of the rollers reduces mechanical strain on the tubing and permits longer periods of use. Product and batch changeovers are easier, faster and safer. The pump can

be opened and closed in two simple steps without removing any parts. The operator can open the pump with one hand, change the tubing and close the pump again. This saves time and increases safety, especially for isolator applications. With the exception of the tubing, the system completely eliminates product contact. This ensures high prod-uct quality by reducing the risk of cross-contamination and minimizes the poten-tial downtime associated with product changeovers.A further advantage of the system is that the low pulsation volumetric flow ensures very precise filling tolerances. As Lee Beaver observes, “filling accuracy is one of the technology’s main bene-fits.” Allergy Labs mainly uses the Bosch filling and closing line for water-based, easily soluble products such as inject-able, sterile generic drugs. The Bosch peristaltic pump is suited for filling vol-umes of 0.1 to 30 milliliters. The pump can also be modified to handle even smaller sizes, flexibly adjusting to each manufacturer’s requirements. “Allergy Labs operates with 2 milliliter fills, so filling accuracy was a big concern for us. But Bosch met all of our specifications,” Beaver explains. “Filling operations are drip-free, and the single-use compo-nents significantly contribute to clean handling.”

Pretty much maintenance-freeAlong with the peristaltic pump, Allergy Labs opted for a new filling and closing line from the FLC series. The FLC 3080 filling and closing machine is designed to fill, sample check-weigh and stopper vials in a continuous motion process. The FLC 3080 uses a vacuum star wheel to accurately position each vial for cap-ping. Additional features include a “V-cleat” conveyor system that enables

users to conveniently run different size vials without changing parts. The linear conveyor system runs horizontally in continuous motion. The containers are carried freely in the laminar-flow stream in an upright position. “The FLC line not only provides the cleanliness we require for our filling operations, it also handles the vials very gently,” says Beaver.On Allergy Labs’ FLC, the peristaltic pumps and a disposable tubing system are fully integrated with the machine’s control system, drive and controllers. An integrated touchscreen ensures easy and automated operations. “At first, we were skeptical about the degree of auto-mation of the FLC, but its set-up was easy: our operators quickly adapted to it and it’s pretty much maintenance-free,” Lee Beaver explains. Bosch recently vis-ited Allergy Labs to perform preventive maintenance work on the machine. “There was just not much to service,” Beaver confirms. “The line has been in operation for over two years now, but it didn’t take us that long to recognize the key benefits for us: safe and reliable vial handling, filling accuracy of the peristal-tic pump technology and the cleanliness of the entire process.”


Jamie Schroetter

Phone: +1 763 493 6773


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Peristaltic pumps today offer an effective alternative to conventional filling systems.


Flexible solutions for complex formulations

Cipla relies on Bosch capsule filling machine GKF 2500 ASB 100%

Cipla, one of the largest Indian pharmaceutical manufacturing companies, has

experienced a boost in demand. To enhance its filling capacities, Cipla chose a new

capsule filling machine from Bosch Packaging Technology.

Cipla was established in 1935 and today is one of the world’s largest generic pharmaceutical companies with a presence in over 170 countries. The company started business with the vision of making India self-reliant and self-sufficient in healthcare, and now manufactures over 2000 products in 65 therapeutic categories and more than 40 dosage forms, including tablets and capsules, pre-filled syringes and other pharmaceutical APIs. Cipla is well-known around the world for producing affordable, high-quality medicines that meet the needs of patients across therapies.Sudhir Gule, head of Cipla’s Kurkhumbh plant, points out that “India has seen a paradigm shift over the past 15 years. We now have one of the best pharmaceutical industries in the world. This has led to numerous changes and an increase in the sophistications of our formulations and exports.” While the

local demand is continuously growing, the same accounts for drug exports. India already is a global leader in the generic drug market, and national companies are currently expanding their sales to other emerging markets, as well as the United States and Europe.

The best matchFollowing the demand of the developed markets, many companies have invested in sophisticated machinery to meet the more complex requirements. “The regulations are very strict and we must focus on high quality to be able to compete with local providers,” Sudhir Gule explains. Cipla is well-positioned to answer the demands both locally and globally. Over the past years, the com-pany has also continuously equipped its plants with new high-performance machines.For more than ten years, Cipla has been one of Bosch’s key customers in India

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and uses different generations and types of GKF filling machines, as well as several KKE checkweighers at different production sites across India. The latest successfully completed project is the installation of a new capsule filling ma-chine at Cipla’s Kurkhumbh plant. “Just as we do for all our machines, we went through a rigorous selection procedure and compared the relevant data of dif-ferent machines available in the market,” Sudhir Gule emphasizes. “The GKF 2500 ASB 100% was the best match for our requirements and our experience proves us right.”

Highest safety and precisionErgonomic, clean and secure handling is at the heart of the GKF 2500 ASB 100% capsule filling machine. It is suited for a vast amount of products with an output of up to 150 000 capsules per hour. Its modular design facilitates quick changeovers and high productivity;

the cGMP-compliant production cabin is easily accessible for user-friendly operation and cleaning. The automatic trouble-shooting features ensure the highest pharmaceutical safety: deformed or damaged capsules are removed even before they arrive at the filling station. During capsule closing, the capsule body scanner recognizes incomplete capsule portions. The GKF 2500 ASB 100% is equipped with a high-precision gravimetric online weight control system, which controls the weight of every single capsule. Based on communication between the checkweigher and the dosing sta-tion, the analysis software calculates an average filling weight from and compares it with the theoretical filling weight. Only those capsules whose weight is within the pre-set tolerances are accepted, all others are rejected automatically.

Adapting to market requirements“Our team is very satisfied with the new capsule filling machine. It is not only especially user-friendly. It also gives us the flexibility to adapt to market requirements and to quickly switch from one product to another without long changeover times. Moreover its compact design helped us to optimize our working space. Last but not least, the online checkweigher ensures exact filling weights, which is an important requirement for us and our customers,” Sudhir Gule underlines.


Andreas Nüssle

Phone: +49 711 811 57886


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