Page 129 - Assurance of Sterility for Sensitive Combination Products and Materials
P. 129
Based on ISO 11607
Seal integrity
parameters and sterilization
-Worst case sealing/forming
transport testing conditions
Performance testing
- Define climatic and
Material properties
Visual inspection
Microbial barrier
Example of a validation workflow 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 Performance Operational qualification Post sterilization testing quali
Seal integrity
Installation qualification (IQ) Fig. 5.8
