AseptiSafe passes sterility challenge for filling component transfer
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 spilt butterfly valve has a number of practical advantages over existing sterile transfer techniques although for years lacked the microbiological data to support its use. An indpendent 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.