A new pharmaceutical product requires a lot of lead time. Clinical trials are a major step on the path to authorization. To thoroughly test the product, manufacturers need small drug volumes filled in sterile conditions. “Personalized medicine asks for machines with especially high flexibility while the production output can be slightly lower,” Klaus Ullherr, product manager at Bosch Packaging Technology, explains. Different packaging materials need to be changed with as few different format parts as possible.
Safe and flexible at the same time
Based on these requirements, Bosch developed the pilot machine MHD 2010 with the biopharmaceutical company AbbVie. The machine was presented for the first time at Pharmatag 2016 in Crailsheim, Germany. The MHD combines manual, semi-automated and fully automated processes in a small space. “Thanks to the manual in-feed of the pre-sterilized containers, we are able to save space and achieve high flexibility, while fully automated steps such as filling via peristaltic pump provide maximum accuracy and safety in the sterile area,” Ullherr says.
The MHD flexibly fills liquid pharmaceuticals into vials, syringes and cartridges. The different process steps can be changed at any time thanks to the new fill-finish concept, where industry robots transfer the containers from one station to the next. “This enables customers to adapt the processes according to their product and packaging style,” Ullherr explains. “Despite its small footprint, the machine not only features the filling, stoppering and capping functions. It is also equipped with a 100% in-process weighing system. And there is still spare space available to add further functions for currently not yet known packaging styles.” Bosch also provided the connection to a freeze dryer. This makes the MHD an ideal solution for the filling of small drug volumes for clinical trials.
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