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AseptiSafe® Passes Sterility Challenge for Filling Component Transfer

23 September, 2015 | ChargePoint Technology

ChargePoint Technology has passed a sterility challenge for its AseptiSafe® split butterfly valve, which has been specifically designed to transfer aseptic products and components in fill/finish, biotech and sterile API production.

The Split Butterfly Valve (SBV) has a number of practical advantages over existing sterile transfer techniques although for years lacked the microbiological data to support its use. An independent study, by 3rd party SKAN AG (Basel, Switzerland), has been carried out with the aim of gathering this data by means of qualifying the technology.

The testing was completed with excellent results, showing that all stoppers were free from any microbial contamination. Thus it has been clearly demonstrated that aseptic transfer of stoppers through the AseptiSafe® valve assembly can be successfully achieved in the sterile processing of pharmaceutical products.

Microbiological study of aseptic transfer of vial stoppers with ChargePoint AseptiSafe® split butterfly valve from ChargePoint Technology (