Who can help validate my sterile barrier packaging to ISO 11607?
ISO 11607-1 covers requirements for materials and sterile barrier systems; ISO 11607-2 covers validation of forming, sealing and assembly processes. A typical programme combines process validation, accelerated aging and distribution with integrity and strength testing.
What the method covers
Terminally sterilized medical device packaging; methods usually include ASTM F1980 aging, ASTM D4169 or ISTA distribution, F88, F1929/F2096.
Applicability caveats
- Accelerated aging must be followed by real-time aging data per your rationale.
- Labs test; the manufacturer owns the validation and its conclusions.
- Testing a few packages is a feasibility check, not a validation.