Compact and flexible – these are the dominating keywords when it comes to machines for producing and developing parenterals in small batches. If the machine is also supposed to fill pharmaceuticals into different types of packaging, the market does not have that much to offer. This is why the Fraunhofer ITEM and Bosch Packaging Technology developed the filling and closing machine ARF 1010, which is now in operation at Fraunhofer ITEM’s Pharmaceutical Biotechnology Division in Braunschweig, Germany.
The Pharmaceutical Biotechnology Division of the Fraunhofer Institute of Toxicology and Experimental Medicine (ITEM) has been developing biopharmaceutical substances for 20 years. The new facility of the Fraunhofer ITEM Pharmaceutical Biotechnology Division in Braunschweig was inaugurated in September 2013. During the inauguration, the Fraunhofer ITEM also presented the new filling and closing machine ARF 1010, which is the result of the first collaboration with Bosch Packaging Technology.
“The Fraunhofer ITEM wants to offer customers quick access to sterile biopharmaceutical trial drugs. Therefore, we needed a solution that operates efficiently, even with the smallest batches and different container types. Our idea was a combination machine that would efficiently fill and close both vials and ampoules, while saving space and conforming to the strict requirements of GMP Annex 1, the German Drug Act, and the German Genetic Engineering Safety Regulations (GenTSV),” Dr. Holger Ziehr, head of Pharmaceutical Biotechnology, concludes. “We work with active ingredients and had no previous experience with this type of filling operations. We quickly came to realize that there were not many suitable solutions available in the market,” says Dr. Luma Baydoun, head of quality control at Fraunhofer ITEM. At Interpack 2008, the project managers discussed their requirements with Bosch Packaging Technology and laid the foundation for a successful partnership.
Product manager filling and closing machines for ampoules
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