Blog - Aseptisafe
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.
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 Read more...
ChargePoint Technology will introduce the latest technology for aseptic processing at the PDA Annual Meeting. This event will take place at the JW Marriott in San Antonio, Texas, between the 7th and 9th April. Read more...