Case Study

Terminal Sterilized Product: Validating PQ Of Manufacturing Equipment

Source: SP Scientific
LC - Associated Files Pharm NL 2

The introduction of a new rotary vial washer used in the process of manufacture of terminally sterilized products requires validation in accordance with GMP to ensure verification of performance. A PQ protocol was required to test the effectiveness of the machine with regard to the manufacture of terminally sterilized parenteral products.