Diabetes has developed into a widespread disease in India. According to the International Diabetes Foundation, India currently ranks second in the list of globally affected people with 65 million diabetes patients. The need for medicine is equally high. Insulin pens enable patients to administer the drug as easily and painlessly as possible; a product that the global pharmaceutical manufacturer Sanofi now also plans to produce in India. For the successful market introduction, the insulin must be safely filled into cartridges. Therefore, Sanofi requires a safe and reliable solution for filling operations. The company’s long-term partner Bosch developed a suitable line concept for all process steps of the new production site in Hyderabad.
Reduced cleanroom classification
Realization of the project began in March 2015. Two entire filling lines for three milliliter cartridges are being manufactured at the Bosch site in Crailsheim, Germany. The lines consist of a washing machine, a sterilization tunnel and an MLD filling and closing machine each, and can both be used to fill different types of insulin in the future. What’s really special about the lines: it is the first time that Bosch is equipping a line with isolator technology for an Indian manufacturing site. “To date, this technology is rather new to the Indian market,” Rainer Lintermann, project leader at Bosch Packaging Technology, explains. “However, the isolator not only makes it possible to attain higher safety. It also achieves savings as far as cleanroom classification is concerned.”
Compared to Restricted Access Barrier Systems (RABS), which require a class B cleanroom, isolators can also be used in a class D environment. Moreover, they require less maintenance and energy costs due to reduced pressure control technology, less air locks and ventilation systems. For Sanofi, the high protection of operators and products is particularly important. The isolator technology prevents contamination during production. So 2015 will be a busy year in Crailsheim. The lines are due to be shipped to India in December, so that Sanofi can begin with commissioning in 2016.
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