Page 130 - Assurance of Sterility for Sensitive Combination Products and Materials
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Package/container closures 113
Performance qualification (PQ) Nominal sealing/forming parameters, Three runs, Three lots Seal or burst strength Visual inspection Seal integrity Based on ISO 11607
Stability testing (Accelerated and Real time aging) Worst case or nominal sealing/forming parameters and sterilization Seal or burst strength Visual inspection Seal integrity Microbial barrier Material properties Post sterilization testing Worst case sealing/forming parameters and sterilization Seal or burst str
Example of a validation workflow Operational qualification (OQ) Worst case sealing/forming parameters Seal or burst strength Visual inspection Seal integrity Sample validation flow diagram.
Installation qualification (IQ) Fig. 5.8
