A case study looking at the upgrade of a facility in China to meet GMP requirements for closed handling of vial stopper components from an autoclave to a filling line
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.
The client needed to upgrade their facility to meet GMP requirements for closed handling of vial stopper components from an autoclave to a filling line. The room background classification was a Grade B which means the critical area handling must be maintained under sealed conditions once sterilised.
Due to the confined space available, it was deemed unfeasable to introduce additional RABS and air handling systems.