GMP upgrade for sterile stopper handling
In 2011 the State Food and Drug Administration of China (SFDA) published a revised version of the GMP regulation. Hence, all new and upgraded manufacturing facilities will need to comply with these requirements with strict deadlines for existing manufacturers of sterile products.
ChargePoint Technology contributed with a local sterile manufacturer in China to upgrade their facility to meet GMP requirements for closed handling of vial stopper components from an autoclave to a filling line.
Due to the confined space available, it was unfeasible to introduce additional RABS and air handling systems. Therefore, Austar -official partner of ChargePoint Technology in China- worked with the client to introduce ChargePoint AseptiSafe® aseptic transfer valves, which are specifically designed to handle sensitive ingredients and components in aseptic processing.
The introduction of ChargePoint AseptiSafe® ensured a simple space efficient approach to closed handing, removing the risk of contamination form the operator intervention thus providing the required sterility assurance.
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