A revolutionary leap has been made in modern biotech and the thinking behind it is, in fact, rocket science.
ChargePoint Technology is using a hydrogen peroxide vapour cycle in split butterfly valve devices. The AseptiSafe transfer system produces a classified area the size of a dinner-plate and its very compact size means that the need for the highest classification cleanrooms and isolators is lessening.
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.
Maintaining sterility assurance during vessel charging processes is a common challenge for biopharmaceutical manufacturers. Whether a formulation vessel, reactor, mixer or other kind of vessel is charged, sterile and containment barriers need to be maintained at high levels to eliminate the risk of product contamination or exposure of potent particulate to the operating environment.