Can microbial challenges be eliminated from package validation? If so, how can the results of physical testing justified without correlation to microbial data?
For package validation, microbial challenge testing is performed infrequently or not at all by most medical device manufacturers. The use of physical testing to prove the maintenance of package integrity; when a validated sterilization process has been demonstrated is sufficient evidence to indicate that the product is sterile. Porous package substrates must be challenged and must demonstrate that the substrates themselves are microbial barriers, ISO 11607-1:2006, section 5.2.3, see note. Reference ASTM F1608:2000 “Standard test method for microbial ranking of porous packaging materials (exposure chamber method). For non-porous materials, demonstration that the substrate is impermeable shall satisfy the microbial barrier requirement. Reference Annex C, ISO 12607-1:2006.
