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 its facility to meet GMP requirements for closed handling of vial stopper components from an autoclave to a filling line.
Due to the confined space available, it was unfeasible to introduce additional RABS and air handling systems. Therefore, Austar (official partner of ChargePoint Technology in China) worked with the client to introduce ChargePoint AseptiSafe aseptic transfer valves, which are specifically designed to handle sensitive ingredients and components in aseptic processing.
A 150mm ChargePoint AseptiSafe system was installed within the customer's existing line to ensure safety and cleanliness during the transfer of vial stopper components.
ChargePoint AseptiSafe utilises a simple Steam in Place (SIP) process prior to material transfer ensuring that required Sterility Assurance Levels (SAL) are achieved. Furthermore, this aseptic transfer valve provided a cost-effective solution to this customer by increasing the volume of batch transfer without compromising the flow and integrity of the components.
