Case Study

Vaccine Manufacturer Installs Vial Filling Lines To Align With Pharmaceutical Capacity Needs

By Dieter Bandtel

Vaccine Manufacturer Installs Vial Filling Lines To Align With Pharmaceutical Capacity Needs

By Dieter Bandtel

The Indian vaccine manufacturer Serum Institute of India has a vision – to continually increase the production of affordable, high-quality vaccines. The founder and owner Dr. Cyrus S. Poonawalla believes that every child in the world should be granted access to inexpensive bacterial and viral vaccines against Tetanus, Influenza or MMR (mumps, measles and rubella), to name just a few. Dr. Poonawalla and his colleagues are by no means lone wolves, as numerous humanitarian organizations and international celebrities accompany them on their charitable journey. In daily production business, India’s leading biotech company can rely on first-class machinery from Bosch Packaging Technology to successfully manufacture their life-saving medication.

He is well-known way beyond the Indian borders, he has been awarded many prizes, a school in Pune bears his name – Dr. Cyrus S. Poonawalla is a true philanthropist and a role model for many. 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 college, Dr. Poonawalla, who is also a dedicated and well-known horse breeder in India, wanted to start a business in the healthcare sector. He 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 expensive 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.

Today Serum Institute is one of the largest manufacturers of vaccines in the world with a huge capacity of billions of different vaccine doses annually. Reaching out to more than 140 countries, it is estimated that every second child immunized receives at least one vaccine produced by Serum Institute. Even newer vaccines, such as the five-in-one pentavalent (Penta*) vaccine and anti-rabies vaccines, can now be offered at affordable prices, not just to children in India but around the world. The manufacturer aims at targeting more countries every year.

The Indian vaccines czar

The company is the first across Asia to be qualified by the World Health Organization (WHO); it supplies its products to the United Nations Children’s Fund (UNICEF) and the Pan American Health Organization (PAHO). Equally important as the support and recognition from some of the world’s most powerful humanitarian organizations is the interest of influential people in the good deeds of Dr. Poonawalla and his employees. Serum Institute is proud of the relationships with celebrities and fellow philanthropists including Bill Gates and Prince Charles. In collaboration with the Bill & Melinda Gates-funded Meningitis Vaccine Project, a partnership between WHO and the international non-profit organization PATH, Serum Institute produced the new Meningitis vaccine MenAfriVac for the African market at only 50 cents per dose.

For all these reasons, Dr. Poonawalla is more than a big personality in India. The national trade magazine Bio Spectrum even honorably describes him as the “Indian vaccines czar”. His charitable drive has influenced other dominant players within the industry to follow his good example. As a result of its pioneering work, Serum Institute has managed to bring down the prices of newer vaccines, such as Penta vaccine, and will not stop until all vaccines are affordable for the entire world population.

Reliability, quality and durability

“With our high-class facilities, we are able to manufacture international quality vaccines at comparatively low production costs,” says Dr. Ravetkar. The 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 research, 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 explains. “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 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, freeze-dry vials are crimped on a stand alone vial capper VRK, all of which were manufactured at the Bosch Packaging Technology location Crailsheim, Germany.

An additional FXS 2020 filling and closing line for pre-sterilized nested syringes was brought to Pune from Bosch in China, followed by a new FLC vial line from Crailsheim. 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 professional service around the clock. “All members of Bosch are dedicated to walk the extra mile,” he emphasizes. “Representatives from India and Germany regularly visit Serum Institute. Many up-front meetings were dedicated to discussing our needs.”

Completing the mission

To obtain the best possible machine output, Serum Institute and Bosch continuously work on slight adaptations to the lines. “Bosch appreciates our feedback and is eager to learn from our experience,” 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 requirements.” 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.

* The five-in-one pentavalent vaccine protects children from diphtheria, tetanus, whooping cough, hepatitis B and Haemophilus influenzae type b (Hib) which causes pneumonia and meningitis.

Sources

Contact

Dieter Bandtel

Product Manager Vials Liquid & Dry

Bosch Packaging Technology

Phone: +49 7951 402-362

Email: dieter.bandtel@bosch.com

About Bosch Packaging Technology – product division Pharma

Bosch Packaging Technology – product division Pharma is one of the leading providers of process technology and packaging solutions for the pharmaceutical industry. The portfolio includes single units, complete lines and integrated systems for the manufacturing and processing of liquid and solid pharmaceuticals. It also includes process technology, primary packaging, inspection technology for different application fields and packaging types. Secondary packaging with qualification and validation, software solutions for track and trace and technical customer service are also available.

The following product brands are part of the Bosch portfolio for the pharmaceutical industry: Hüttlin, Klenzaids, Moeller&Devicon, Pharmatec, SBM Schoeller-Bleckmann Medizintechnik, Sigpack and Valicare. For more information please visit www.boschpackaging.com.

About Bosch Packaging Technology

Based in Waiblingen near Stuttgart, Germany, and employing 6,100 associates, the Bosch Packaging Technology division is one of the leading suppliers of process and packaging technology. At over 30 locations in more than 15 countries worldwide, a highly-qualified workforce develops and produces complete solutions for the pharmaceuticals, food, and confectionery industries. These solutions are complemented by a comprehensive after-sales service portfolio. A global service and sales network provides customers with local points of contact. Additional information is available online at www.boschpackaging.com.