Blog - Sterility assurance
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...