packazine Pharma · Issue 2014 Serum Institute | High-quality vaccines for everyone Novartis | Customized system for highest flexibility 2 | packazine Table of contents | Editorial Table of contents 10 16 News Facts & Trends 04 Diabetes | Fighting a global pandemic Customers & Markets Pharma 07 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 Cover With a fully automated packaging line Excelvision accelerated production with help from Bosch. www.boschpackaging.com [email protected] packazine | 3 18 Editorial 21 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 Friedbert Klefenz under one umbrella. We will keep with the tradition of Interpack President, participation this year, too, by using the show as a platform to pre- Bosch Packaging Technology 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 equipment is designed to support fast changeover times, quick and thorough cleaning, and simple operation – 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 continue 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 4 | packazine News Facts & Trends Diabetes Care: fighting a global pandemic 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. In type 1 diabetes, the body’s own immune cells are directed against the insulin-producing beta cells of the islets of Langerhans in the pancreas, often already in childhood. The resulting insulin deficiency always requires insulin therapy. 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 membranes and from transporting glucose into the cells. The result is increased blood glucose concentration, which often goes unrecognized for many years. Changing diabetes therapies All approaches to diabetes therapy have always been aimed at controlling blood sugar levels and preventing large fluctuations down (hypoglycemia) or up (hyperglycemia). Today, insulin is obtained packazine | 5 from bacteria using biotech methods and Focus on safety and output brought to the market as human insulin. Pens are currently the most widely used cessing of cartridges for insulin pens A very significant progress was domestic system for insulin injection. For diabetes particularly in the so-called “pharmerg- driven the use of machines for the pro- self-monitoring of blood glucose in the patients, easy and safe handling of the ing” markets. The criteria by which 1980s. Further milestones include the pens is the most important criterion. manufacturers choose their machines approval of so-called insulin analogs, that Insulin manufacturers in turn must pay are high output, high availability, and work particularly quickly or uniformly, as particular attention to a comparatively reproducible precision in insulin produc- well as insulin pumps, which continu- inexpensive production, sterile filling tion. Filling and closing machines for car- ously and flexibly provide diabetes type 1 and the integrity of the materials used tridges with a capacity of up to 600 units patients with short-acting insulin. by reducing manual intervention during per minute are now considered state-ofthe-art. Modern plants and lines are Moreover, insulin pens were developed the production process as much as pos- for more ease of delivery. They are used sible. Modern barrier technology com- compatible with all current filling tech- as multiple application systems with pletely seals off products, processes, nologies and partly also equipped with pre-filled insulin cartridges. For diabetes equipment and operators from each combi filling stations for different drug patients, the independent administra- other. Insulin manufacturers also in- requirement and packaging types. tion of insulin is now a lot easier. Due to creasingly rely on the use of isolators, their shape, the pens can not only be which ensure higher product quality at Passing all processes unscathed transported more conveniently, they can lower cost compared to conventional In all process steps, the cartridge is also be applied “en route” without at- cleanrooms. exposed to different temperatures, pres- tracting attention. Patients are able to In addition to the omnipresent cost fac- sures, and movements. The higher the better adapt the therapy to their own tor, the growing number of diabetes pa- speed of a filling and closing machine, rhythm of life. tients in the emerging economies has the more the glass is exposed to physi- 6 | packazine News Facts & Trends cal stress. This can cause damage to the Precise filling and inspection to be easily transferred to production glass, such as cracks, chips, or fractures. For a full and bubble-free filling 80 per- systems via scale-up. Inspection is These defects result in product loss and cent of the maximum quantity is dosed equally important: empty and full glass higher costs for pharmaceutical produc- into the cartridge before the remainder containers can be quickly and accurately ers, which machine manufacturers are is filled to the full point by laser-scanning inspected for particles in the liquid or counteracting with new solutions for the cartridge neck. The laser sensor for cosmetic defects. gentle processing. The primary objective switches off the dosing when the fluid is hence to minimize contact between meniscus reaches the laser beam. Significantly improved quality of life glass containers. 100-percent inspection plays an impor- It is still uncertain when alternatives to During loading of the cleaning machine, tant role for the exact closure of the car- injecting insulin will prevail. But the near for instance, the cartridges are trans- tridges. With the “Static Division” (SD) future already promises the introduction ported in so-called transport pucks in a technology, light is projected through the of further insulin formulations and new, row to prevent glass-to-glass contact. liquid onto an optical sensor, which improved insulin pens. Although preven- During the sterilization process, the glass allows differentiation between moving tion and avoidance of long-term conse- is exposed to an enormous heat influence, particles and static objects, for instance quences must always be top priority, leading to the expansion of the glass inhomogeneity in the glass packaging. advances in treatment provide people mass. This can be compensated by a con- Automatic camera-based systems in turn affected by diabetes with the hope of veyor belt with flexible lateral support, detect both particles and cosmetic further, significant improvement in their which widens immediately after the tun- defects. quality of life. nel entrance. To protect the cartridges Even at an early developmental stage of from damage from tipping over, they are insulin preparations, safe filling of car- For more information please contact: transported to the inlet of the filling ma- tridges with manual and semi-automated Dr. Johannes Rauschnabel chine in bulk, where a star wheel sepa- test machines has priority. It is particu- Phone: +49 7951 402 452 rates them again. Robotic feeding and re- larly important that these machines can E-mail: [email protected] moval of cartridges can provide further be equipped with different filling tech- reduction in physical stress. nologies and allow the filling parameters A key milestone in diabetes therapies: application technologies like insulin pumps and pens packazine | 7 Full speed ahead for Normon New Hüttlin fluid bed system HDGC 600 triples batch sizes for Laboratorios Normon while significantly reducing costs With more than 75 years of experience products such as antibiotics, high poten- cooperation with long-term partner on the Spanish market, Normon is cy products, anesthetics, analgesics and Hüttlin GmbH, located in Schopfheim, among the leading pharmaceutical manu- anti-inflammatories, which are distribut- Germany. Hüttlin has been part of facturers in the country. What started as ed worldwide. a small family business in 1937 has ex- Bosch Packaging Technology since 2011. Together with the Bosch brand Manesty, panded into a corporation that now em- Based on solid experience Hüttlin completes Bosch’s process tech- ploys around 1400 people who share a With the aim of reducing costs, Normon nology portfolio for pharmaceuticals. production space of 80 000 square me- planned to significantly increase its From development to production ma- ters. More than 90 percent of the pro- batch sizes for certain products. The chinery, all Hüttlin systems are designed duction outcome consists of generic manufacturer needed to pay close atten- to meet customer and market require- drugs. The production site accommo- tion to the high quality and safety stan- ments. The portfolio covers equipment dates machines for manufacturing liquid dards and economic aspects, as well as for mixing, granulating, drying and coat- vials, freeze-dried vials, dental cartridges, flexible production sizes and times. This ing, as well as comprehensive contain- ampoules or infusion bags, as well as for required the use of flexible and reliable ment solutions and laboratory installa- granules, capsules, and tablets including technology, and resulted in a renewed tions. 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, responsible for Technical Operations and Industrial Processes at Laboratorios Normon, S.A. “It quickly showed that the HDGC 600 offered the specific life science functionality we wanted, backed by the robust technology we needed. Normon also required a system which provides the highest possible performance, reliability and functionality, while giving us the flexibility to quickly make changes to our processes. We wanted to duce the same amount of product. In- can simply select a new functionality give our production a tool that moves us cluding documentation time, the produc- such as the coating process. All recipes to the front of the technology race,” tion of three batches on the HDG 200 from laboratory equipment can be easily Gonzalo Fernández Govantes adds. amounted to 20 hours. By tripling the scaled-up to both the HDG 200 and the batch size on the new HDGC 600, the new HDGC 600. Gonzalo Fernández Tripling batch sizes with the Hüttlin production of only one batch now suf- Govantes confirms, “Our staff has been HDGC 600 fices to significantly save time and costs. working with Hüttlin processing ma- The Hüttlin fluid bed systems are based Moreover, the bottom-spray technology chines for ten years and has been trained on a modular design. They can easily be of the HDGC 600 with the air distri- on the equipment. So we can realize configured either as dryer (HD), dryer bution plate Hüttlin Diskjet and the changes without any additional costs.” granulator (HDG) or dryer granulator 12 three-component spray nozzles en- Homogenous drying results, the omis- coater (HDGC). Therefore, the process sure fast and uniform mixing, high spray sion of dead zones in the product bowl steps of drying, granulating and coating rates, shorter drying periods and even and preventing the product from sticking of fine particles, powders and pellets spray distribution as well as a minimum and clogging to the walls are further can be realized with one machine and of spray losses. “Since we tripled batch benefits for Normon. one single product container. Before im- sizes, we have been able to reduce docu- plementing the Hüttlin HDGC 600 at its mentation, the number of quality control Smooth implementation production facility in Madrid, Normon analyses as well as working hours and It took less than twelve months from carried out its granulation processes on energy consumption, and ultimately have project kick-off until the HDGC 600 went several smaller Hüttlin fluid bed systems. reduced process times of up to 30 per- into production. According to Normon’s While Normon still uses these machines cent,” Gonzalo Fernández Govantes Gonzalo Fernández Govantes, “The for certain products and smaller batch confirms. Hüttlin service team was constantly on- sizes, operations for larger batches are The HDGC 600 satisfies all Normon’s key site to ensure a smooth implementation.” much more efficient now with a machine requirements. The company is able to After carrying out first on-site tests, the at higher production capacity. Today mix products with different densities in Normon only needs half the time to pro- one single process container. Operators Bosch team remained in place to accompany the first production batches. packazine | 9 Normon produces more than ten different products on the new fluid bed system. Some new products have already been approved by the Spanish Agency of Medicines and Medical Devices (AEMPS). Normon is set to launch new generics, and its development teams are preparing most of these products in the Hüttlin laboratory equipment. This equipment documents and controls product development processes and makes it easy to get a quick authorization 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 manufacturing 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. “Operating the Hüttlin HDGC 600, we can go full speed ahead in manufacturing generics and defend our position as one of the leading pharmaceutical manufacturers in Spain.” For more information please contact: Dolf Oberborbeck Phone: +49 7622 6884 212 E-mail: [email protected] 10 | packazine Customers & Markets Pharma packazine | 11 Packaging line revamped Bosch Packaging Services modifies thermoforming line for packaging of “Emser pastilles” Even the most durable packaging ma- which contains high levels of trace ele- chine, a CUT 120 cartoner and a KWE chine will need spare parts sooner or ments, is obtained by vaporizing water 3000 checkweigher. With an output of up later. But what is to be done if the neces- from a hot mineral spring in Bad Ems. It to 250 blisters per minute, the TLT 1400 sary electronic components are no longer is offered in several dosage forms, such processes the pastilles before they are available? Equipment manufacturers are as saline nasal douches, nasal spray and packed into folding boxes and weighed. required to inform their customers about drops, developed to ease chronic infec- The line’s centerpiece consists of the available technologies and modification tions and dry mucosae. The Emser pas- TLT 1400 thermoforming machine, which is characterized by its flexibility, usability, opportunities in good time to prevent tilles are solely available in pharmacies in machine downtime and production loss. five different flavors and help to moistur- safety and high Overall Equipment Effec- This also applied to the German company ize and clean strained pharyngeal muco- tiveness (OEE). A color touchscreen fa- Siemens & Co. in Bad Ems who produces sae caused by coughing and hoarseness. the well-known “Emser pastilles”. Bosch cilitates the machine’s operation; format parts for different packaging sizes can be Packaging Services modified the compa- “Obsolete spare parts” ny’s TLT 1400 thermoforming machine For generations, Siemens & Co. has been of tools. within a very short time by equipping it relying on technical equipment from The original servo motors of the TLT 1400 with new servo motors, servo controllers Bosch Packaging Technology to pack its belonged to an older generation that is and a new control system. different salt products. For instance, the no longer being produced. This is a mat- Siemens & Co., based in Bad Ems, Ger- company fills its powdery saline nasal ter of so-called “obsolete spare parts” – many, was founded in 1958 and has been douches on a high-performance stick parts and components from third party operating as a family-run company since pack line at rates of up to 1000 packs per providers that are outdated or no longer 1998. It produces salt products for treat- minute. For the Emser pastilles, Siemens available. “Many customers need new ing the upper respiratory tracts, espe- & Co. uses a Bosch packaging line con- components for their machines at short cially the nose and throat. The mineral, sisting of a TLT 1400 thermoforming ma- notice. Only then do they realize that quickly changed, almost without the use 12 | packazine Customers & Markets Pharma certain spare parts are no longer state- Quick support was required, as not only and can be operated as reliably as be- of-the-art or out of stock. So it is all the the servo motors but also all motor con- fore,” explains Hans-Jürgen Meisel, more important to actively inform them trol units and the control system needed service engineer at Bosch Packaging about the availability beforehand and to replacing. Services. Together with the customer, he offer adequate solutions. Due to the “Bosch Packaging Services helped us to tested the motor and control technology rapid pace of technological development, bridge the time gap until the modifica- of the modified TLT 1400 in detail, based electronic components unfortunately of- tion with as little production loss as pos- on the validation protocols. As soon as ten have a short lifespan and are no lon- sible,” Dr. Andreas Keller recalls. “The the last fine tuning was completed, and ger available after only a few years,” ex- modification itself progressed consider- smooth operation of the line was en- plains Andreas Herrmann, service sales ably quicker than expected.” Instead of sured, Siemens & Co. resumed produc- manager at Bosch Packaging Services. taking the estimated eight weeks, the ex- tion of the pastilles on their TLT 1400. With customer letters and so-called up- perienced Bosch technicians managed to “We would carry out another machine grade letters published on the E-Portal, carry out the entire modification project modification with Bosch Packaging Ser- the online ordering platform for spare in half the time. After only four weeks, vices at any time. The technicians are parts, Bosch Packaging Services regu- the TLT 1400 was equipped with a new very familiar with the equipment. They larly informs customers about the avail- motor, control and operation technology, planned the modification of our blister ability of components and suggests mea- and was extensively documented and val- line in a competent manner and quickly sures for preventive modifications and idated. Moreover, the machine obtained put it into practice,” Dr. Andreas Keller a more powerful computer with new confirms. Physically unchanged, the software. To the customer’s complete TLT 1400 in Bad Ems runs as reliably as Modification in only half the time satisfaction, the calculated costs were before. “We were able to resume the “For ten years we have been reliably blis- also reduced by 30 percent. maintenance. tering our pastilles on Bosch’s thermo- packaging of our Emser pastilles in a very short time – and are now hoping for forming machine,” reports Dr. Andreas Quick resumption of production a renewed long lifespan of our TLT 1400,” Keller, operations manager at Siemens & Performance tests, machine qualification Dr. Keller concludes. Co. “We don’t have a second thermo- and validation completed the upgrade forming machine at our disposal and process. “Our customer now has a ma- For more information please contact: must be able to fully rely on this one ma- chine on-site which is equipped with the Andreas Herrmann chine. So we faced a considerable chal- latest drive and control technology. We Phone: +49 711 811 57068 lenge when a servo motor broke down.” had to make sure that it runs as smoothly E-mail: [email protected] packazine | 13 Affordable, high-quality vaccines for everyone Serum Institute of India manufactures life-saving vaccines on Bosch filling lines The Indian vaccine manufacturer Serum awarded many prizes; a school in Pune Dr. Poonawalla tackled this issue and Institute of India has a vision – to contin- bears his name. But his most important has done so ever since with passion, ually increase the production of afford- lifetime achievement, Serum Institute of dedication and perfection. “He has a able, high-quality vaccines. The founder India Ltd., was established back in 1966 very strong philanthropic character and and owner Dr. Cyrus S. Poonawalla be- with the aim of manufacturing affordable through his hard work he is leading the lieves that every child in the world life-saving immuno-biologics for the company by his own example,” says should be granted access to inexpensive entire population. After attending col- Dr. S. D. Ravetkar, executive director, bacterial and viral vaccines. Numerous lege, Dr. Poonawalla, who is also a dedi- Serum Institute of India. humanitarian organizations and inter- cated and well-known horse breeder in national celebrities accompany Dr. India, began manufacturing antitoxins at Joint humanitarian forces Poonawalla and his colleagues on their affordable prices, without making any Today Serum Institute is India’s leading biotech company and one of the largest charitable journey. In daily production compromises on quality. During this business, they rely on first-class machin- time, these vital preventive medicines manufacturers of vaccines in the world ery from Bosch Packaging Technology. were scarcely available and far too ex- with a huge capacity of billions of differ- Dr. Cyrus S. Poonawalla is a role model pensive for the majority of the Indian ent vaccine doses annually. Reaching for many and well-known way beyond population – with the devastating result out to more than 140 countries, it is the Indian borders. He has been of many children dying needlessly. estimated that every second child 14 | packazine Customers & Markets Pharma immunized receives at least one vaccine The company is the first across Asia to Bill Gates and Prince Charles. In collabo- produced by Serum Institute. Even be qualified by the World Health Organi- ration with the Bill & Melinda Gates- newer vaccines, such as the five-in-one zation (WHO); it supplies its products funded Meningitis Vaccine Project, a pentavalent (Penta) vaccine and anti-ra- to the United Nations Children’s Fund partnership between WHO and the inter- bies vaccines, can now be offered at af- (UNICEF) and the Pan American Health national non-profit organization PATH, fordable prices to children around the Organization (PAHO). Serum Institute is Serum Institute produced the new Men- world. The manufacturer aims at target- proud of the relationships with celebri- ingitis vaccine MenAfriVac for the African ing more countries every year. ties and fellow philanthropists including 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. packazine | 15 Dr. Poonawalla’s charitable drive has ogy location Crailsheim, Germany. An lines. “Bosch appreciates our feedback influenced other dominant players within additional FXS 2020 filling and closing and is eager to learn from our experi- the industry to follow his good example line for pre-sterilized nested syringes ence,” says Dr. Ravetkar. “Often it’s the and will not stop until all vaccines are was brought to Pune from Bosch in small things that make a big difference, affordable for the entire world popula- China. for instance easy documentation and tion. Reliability, quality and durability validation processes and small features Small things do matter that make life easier for our machine The latest project, a new FLC vial line operators. With every project, the lines The Serum Bio Pharma Park in Pune is from Crailsheim, is set to be installed in are adapted even better to our require- the first of its kind in the country and the next few months. The lines are used ments.” The filling and closing lines from was designed in strict compliance with for various groups of vaccines, such as Bosch have supported Serum Institute cGMP (current Good Manufacturing vaccines for MMR and Penta vaccines. in coming a step closer to completing Practice) standards. It serves as the re- Apart from the high quality, Dr. Ravetkar Dr. Poonawalla’s mission of supplying search, development and production identified further benefits, ranging from affordable vaccines to all children base for Serum Institute. “Needless to a high durability and reliability to profes- around the world. “Bosch is one of the say, such a modern facility must be sional service around the clock. “All only companies who can truly act as a equipped with highly reliable and state- members of Bosch are dedicated to walk full-range supplier. I believe that every of-the-art machines,” Dr. Ravetkar ex- the extra mile,” he emphasizes. “Repre- company should own a line developed plains. “Bosch is renowned for its high sentatives from India and Germany regu- by Bosch,” Dr. Ravetkar concludes. quality all over the world. I have been in larly visit Serum Institute. Many up-front this business for many years and have meetings were dedicated to discussing For more information please contact: always dreamt of having a Bosch line in our needs.” Dieter Bandtel our facility.” Ten years ago, the first joint To obtain the best possible machine out- Phone: +49 7951 402 362 project marked the beginning of a long put, Serum Institute and Bosch continu- E-mail: [email protected] and trustful relationship. The contact ously work on slight adaptations to the 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 manufacturer and requires high-quality machinery, which is of paramount importance for the safe filling and closing of life-saving 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, freezedry vials are crimped on a stand alone vial capper VRK, all of which were manufactured at the Bosch Packaging Technol- Dr. Cyrus S. Poonawalla, founder of the institute 16 | packazine Customers & Markets Pharma Keeping an eye on automation How an eye drop manufacturer accelerated production with help from Bosch Specializing in sterile manufacturing, new market expansion. Purchasing mul- To meet different customer needs, Excel- Excelvision, based in Annonay, France, tiple storage trays dedicated to each vision required equipment that could be provides contract manufacturing services product format size would have been easily adapted for specific demands. “As for liquid eye drop plastic vials to numer- too costly. However, Bosch’s complete demand increases for single-dosage ous companies. However, to increase line solution allowed the company to use packaging, the new line gives us the flex- production and capitalize on additional one storage tray type for all product ibility to adapt production in the future,” contract manufacturing opportunities, formats. Excelvision enlisted Bosch Packaging adds Philippe Pensuet, head of engineering and EHS at Excelvision. Systems AG, based in Beringen, Switzer- One trusted relationship land, to install a fully automated packag- Having previously used stand-alone ma- Flexibility from primary to secondary ing line. With significantly higher output chines Pierre Laissy, project manager at The bulk vial cards are first manually capabilities, Excelvision expects to Excelvision explains, “Bosch provided loaded into an intelligent feeding unit, increase production by nearly five-fold. the consultation we needed for a suc- which unscrambles and separates them Excelvision manufactures vial cards in cessful upgrade to our first highly auto- equidistantly. The vial cards then travel bulk, each hold five blow-fill-sealed mated, complete line solution.” The to the Sigpack LDF feed placer, which single-use vials. Because the company project also involved a lengthy approval features delta robots that pick and place produces different product shapes and process with Excelvision’s customers as individual cards into an infeed wrapper configurations for its customers, it faced they needed to verify that the new pack- chain. The module is equipped with a a logistical challenge in rapidly packaging aging solution would meet market needs vision detection system that ensures the diverse products. and regulations. During this vetting pro- quality control of the products. It also Prior to working with Bosch, Excelvision’s cess, Bosch regularly consulted with communicates with the robot picker to previous solution was unable to keep up Excelvision about different packaging ensure correct product orientation. with current demand, let alone plan for styles and materials. 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 hermetically sealed, which is critical to protecting the blow-fill-sealed products against water evaporation and light effects. 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 packazine | 17 tool-less changeovers for up to four dif- before they are closed. In addition, the the solution, every quality-relevant step of the way during the process. ferent carton formats, giving Excelvision cartons have a tamper-evident feature, the flexibility to accommodate diverse making it easy for retailers and consum- customer needs. ers to spot packages that have been The Sigpack TTM is equipped with a opened. René Kummer leaflet carousel feeder to place Bosch performed performance and film Phone: +41 58 674 6776 information booklets into the cartons tests to demonstrate the feasibility of E-mail: [email protected] For more information please contact: The vial cards are hermetically sealed in aluminum-laminated film to protect them against light effects and water evaporation. 18 | packazine Customers & Markets Pharma Novartis producing from the birth Bosch supplies flexible filling and packaging line for pharmaceuticals for Novartis in Egypt The medicine of the ancient Egypt is one merger of Ciba-Geigy and Sandoz. The Safety and Environment (HSE) standards, of the oldest documented and has signif- company’s top-selling brands include complying with ISO 14001 and OHSAS icantly influenced today’s medical prac- Glivec to treat certain types of leukemia, 18001, as well as receiving Novartis’ own tice. Since then, medicine has evolved Diovan to treat high blood pressure and internal HSE award 12 years in a row. dramatically, but Swiss pharmaceutical heart failure, and Lucentis to treat eye giant Novartis has been producing and maladies. Three in one filling a wide range of pharmaceuticals The Novartis plant in Cairo, Egypt pro- However, the facility met its match trying from Egypt for more than 50 years. duces enough medication to meet seven to fill and package 15 milliliter plastic percent of the country’s market needs bottles of Otrivin Saline Baby nose From Switzerland to Egypt and beyond and serves as a base for the manufactur- drops, 10 milliliter plastic bottles of Headquartered in Basel, Switzerland, ing and supply chain management of pre- Otrivin nasal spray and 100 milliliter Novartis is one of the largest pharmaceu- scription pharmaceuticals, as well as glass bottles of Catafly Suspension tical manufacturers worldwide. It was es- over-the-counter (OTC) products. The cough syrup. Varying consistencies from tablished in 1996 as the result of the Cairo facility meets the highest Health, oily nose spray and drops to sticky cough packazine | 19 place of western medicine syrup presented one hurdle. The differ- were impressed by the flexibility of the ionizes the blowing air, which neutralizes ent packaging formats presented another company’s equipment and confident that the electrostatic loads on the inner sur- – particularly since these require differ- Bosch had the capabilities to produce a face of the bottles and facilitates easy ent types of closures. While a screw cap single-line solution for these three prod- foreign particle removal. Because this and measuring cup are necessary for the ucts,” says Mohamed Galal, project man- function is not needed for glass bottles, cough syrup, an insert and screw cap for ager at Novartis in Egypt. it can be switched off easily during pro- nasal drops and spray pump with screw duction. The bottles then move into a lin- cap are needed for nasal spray. Lean and clean ear piston filling machine equipped with Novartis needed a solution that is highly Bosch customized the line that met ten nitrogen pre-flushing nozzles and ten flexible and easy to clean during change- Novartis’ criteria, starting with a bottle fill nozzles. Nitrogen flushing reduces the overs between products. Novartis en- unscrambler, followed by an air blower oxygen content in pharmaceutical prod- listed Bosch Packaging Technology, a to clean inside all three bottles and ucts to prevent oxidation after capping. leading provider of packaging solutions prevent particle contamination. To clean To allow for format flexibility, the line for the pharmaceutical industry. “We the plastic bottles, each blowing nozzle incorporates three different rotary 20 | packazine Customers & Markets Pharma capping machines, which are used de- Bosch, which is the ideal solution to ful- them into the cartons. These are only pending on the product. The first is de- fill Novartis requirements in format flexi- some out of many functions that reduce signed to equip each nose spray bottle bility, short changeover times and less machine stops to a minimum and there- with a pump. The second rotary capping maintenance. Novartis runs a total of 15 fore, contribute to higher uptime. machine applies the plug to the nose different format options for product, car- drop bottles. The third capper is used tons and leaflets sizes, which the Bosch Flexibility, speed and energy efficiency for all formats: screwing of all three dif- CUK can easily set in a short time. yield results ferent caps on each bottle and placing The cartoner’s “swing open” leaflet Not only did Bosch’s customized system the measuring cap on the 100 milliliter feeder allows for the operator to quickly for Novartis help the company streamline glass bottle. ensure that leaflets are correctly in place the filling and packaging of three differ- A key function of the line is the Cleaning- without a second person helping from ent products with different packaging in-Place (CIP) Plus-system, which en- the machine rear. Feeding of leaflets and formats, it also enhanced production sures repeatable cleaning results. Clean- carton blanks are located closely to one speed from a rate of 100 bottles to ing must be done after every product. another, further simplifying the opera- 140 bottles per minute for sizes of 10 From filling to capping, the line is fully tor’s work. All cartons are positively and 15 milliliter. For 100 milliliter bottles, covered by a laminar flow hood that opened by a “counter” suction head that speed increased to 120 bottles per min- leverages overpressure to prevent any forms the flat cartons into three-dimen- ute. The equipment also improved energy intrusion of foreign particles. sional shapes and eliminates “dead” savings by US$ 60 000 annually with its After the capping process the bottles are cartons that failed to unfold. This results advances to the bottle cleaning process. conveyed to the labeling system, with in the safe handling of critical carton the exception of the pre-printed nasal qualities, no material or product loss, For more information please contact: spray bottles. For secondary packaging, and decreased production downtime. In Kamel Meherzi the bottles are fed into the continuous addition, all leaflets are carried in Phone: +49 2162 248 304 motion cartoning machine CUK from mechanical grippers that reliably place E-mail: [email protected] packazine | 21 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. Allergy Laboratories, Inc. was estab- years, including a parenteral production for vials and infusion bottles. To satisfy lished in 1929 in Oklahoma City for the facility for contract manufacturing. The the company’s needs, two main require- manufacture of allergenic extracts company is dedicated to high quality, ments had to be fulfilled: first, the line needed to support the growing immuno- strictly controlled manufacturing prac- needed to operate with peristaltic pump therapy practice of founder Dr. Raymond tices, affordable products and excellent technology; second, it had to fit exactly Balyeat. Allergy Labs, as the company is customer service. Allergy Labs applies into the space that had become avail- more widely known, has since evolved this dedication to the manufacturing of able by discarding an old machine. “We into an FDA-licensed pharmaceutical sterile depyrogenated vials, sterile dilu- work with piston pump technology on manufacturer of over 500 different bio- ent and injectable drugs. another line, which can lead to cleaning logical extracts for the diagnostic testing and maintenance difficulties,” says Lee and therapeutic treatment of allergies. Compact and clean Beaver, director of manufacturing at Additional manufacturing and supply In 2010, Allergy Labs turned to Bosch to Allergy Laboratories, Inc. “So we started capabilities have been added over the acquire a new filling and closing machine looking for a filling and closing machine 22 | packazine Customers & Markets Pharma that operates with peristaltic pump The equipment was manufactured on customers. While peristaltic pumps were technology. We checked the market, and the site of Bosch Packaging Technology previously used for the development of Bosch has a good reputation for this in Minneapolis and was installed by an small pharmaceutical batches, they now kind of technology. The open communi- expert engineering team from Bosch. offer a real alternative to conventional cation and expertise of our contacts at filling systems. The Bosch peristaltic Bosch facilitated our decision. They Traditional concept revisited pump combines the advantages of the were always quick in responding to our Six years ago, Bosch started to develop traditional peristaltic concept with opti- queries and requests, which enabled a its own peristaltic pumps to supply the mized dosing accuracy and a very flexi- quick turnaround time for the project.” growing needs of its pharmaceutical ble operating concept. The new tubing packazine | 23 concept of Bosch’s peristaltic pump be opened and closed in two simple users to conveniently run different size makes the technology suitable for all steps without removing any parts. The vials without changing parts. The linear kinds of filling operations, from develop- operator can open the pump with one conveyor system runs horizontally in ment purposes to production-scale fill- hand, change the tubing and close the continuous motion. The containers are ing operations. The offset alignment of pump again. This saves time and carried freely in the laminar-flow stream the rollers reduces mechanical strain on increases safety, especially for isolator in an upright position. “The FLC line not the tubing and permits longer periods of applications. With the exception of the only provides the cleanliness we require use. Product and batch changeovers are tubing, the system completely eliminates for our filling operations, it also handles easier, faster and safer. The pump can product contact. This ensures high prod- the vials very gently,” says Beaver. uct quality by reducing the risk of cross- On Allergy Labs’ FLC, the peristaltic contamination and minimizes the poten- pumps and a disposable tubing system tial downtime associated with product are fully integrated with the machine’s changeovers. control system, drive and controllers. An effective alternative to conventional A further advantage of the system is that integrated touchscreen ensures easy filling systems. the low pulsation volumetric flow and automated operations. “At first, we ensures very precise filling tolerances. were skeptical about the degree of auto- As Lee Beaver observes, “filling accuracy mation of the FLC, but its set-up was is one of the technology’s main bene- easy: our operators quickly adapted to it fits.” Allergy Labs mainly uses the Bosch and it’s pretty much maintenance-free,” filling and closing line for water-based, Lee Beaver explains. Bosch recently vis- easily soluble products such as inject- ited Allergy Labs to perform preventive able, sterile generic drugs. The Bosch maintenance work on the machine. peristaltic pump is suited for filling vol- “There was just not much to service,” umes of 0.1 to 30 milliliters. The pump Beaver confirms. “The line has been in can also be modified to handle even operation for over two years now, but it smaller sizes, flexibly adjusting to each didn’t take us that long to recognize the manufacturer’s requirements. “Allergy key benefits for us: safe and reliable vial Labs operates with 2 milliliter fills, so handling, filling accuracy of the peristal- filling accuracy was a big concern for us. tic pump technology and the cleanliness But Bosch met all of our specifications,” of the entire process.” Peristaltic pumps today offer an Beaver explains. “Filling operations are drip-free, and the single-use compo- For more information please contact: nents significantly contribute to clean Jamie Schroetter handling.” Phone: +1 763 493 6773 E-mail: [email protected] Pretty much maintenance-free Along 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 capping. Additional features include a “V-cleat” conveyor system that enables 24 | packazine Customers & Markets Pharma 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 local demand is continuously growing, today is one of the world’s largest the same accounts for drug exports. generic pharmaceutical companies India already is a global leader in the with a presence in over 170 countries. generic drug market, and national The company started business with companies are currently expanding their the vision of making India self-reliant sales to other emerging markets, as well and self-sufficient in healthcare, and as the United States and Europe. now manufactures over 2000 products in 65 therapeutic categories and more The best match than 40 dosage forms, including tablets Following the demand of the developed and capsules, pre-filled syringes and markets, many companies have invested other pharmaceutical APIs. Cipla is well- in sophisticated machinery to meet known around the world for producing the more complex requirements. “The affordable, high-quality medicines that regulations are very strict and we must meet the needs of patients across focus on high quality to be able to therapies. compete with local providers,” Sudhir Sudhir Gule, head of Cipla’s Kurkhumbh Gule explains. Cipla is well-positioned plant, points out that “India has to answer the demands both locally and seen a paradigm shift over the past globally. Over the past years, the com- 15 years. We now have one of the best pany has also continuously equipped pharmaceutical industries in the world. its plants with new high-performance This has led to numerous changes and machines. an increase in the sophistications of our For more than ten years, Cipla has been formulations and exports.” While the one of Bosch’s key customers in India packazine | 25 and uses different generations and the cGMP-compliant production cabin Adapting to market requirements types of GKF filling machines, as well as is easily accessible for user-friendly “Our team is very satisfied with the new several KKE checkweighers at different operation and cleaning. The automatic capsule filling machine. It is not only production sites across India. The latest trouble-shooting features ensure the especially user-friendly. It also gives successfully completed project is the highest pharmaceutical safety: deformed us the flexibility to adapt to market installation of a new capsule filling ma- or damaged capsules are removed even requirements and to quickly switch chine at Cipla’s Kurkhumbh plant. “Just before they arrive at the filling station. from one product to another without as we do for all our machines, we went During capsule closing, the capsule long changeover times. Moreover its through a rigorous selection procedure body scanner recognizes incomplete compact design helped us to optimize and compared the relevant data of dif- capsule portions. our working space. Last but not least, ferent machines available in the market,” The GKF 2500 ASB 100% is equipped the online checkweigher ensures exact Sudhir Gule emphasizes. “The GKF 2500 with a high-precision gravimetric online filling weights, which is an important ASB 100% was the best match for our weight control system, which controls requirement for us and our customers,” requirements and our experience proves the weight of every single capsule. Sudhir Gule underlines. us right.” Based on communication between the checkweigher and the dosing sta- For more information please contact: Highest safety and precision tion, the analysis software calculates Andreas Nüssle Ergonomic, clean and secure handling an average filling weight from and Phone: +49 711 811 57886 is at the heart of the GKF 2500 ASB compares it with the theoretical filling E-mail: [email protected] 100% capsule filling machine. It is suited weight. Only those capsules whose for a vast amount of products with an weight is within the pre-set tolerances output of up to 150 000 capsules per are accepted, all others are rejected hour. Its modular design facilitates quick automatically. changeovers and high productivity;
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