Accelerated Aging Testing for Medical Device Packaging: ASTM F1980 Guide
Key Takeaways ASTM F1980 is the standard guide for accelerated aging of sterile barrier systems, enabling manufacturers to generate shelf life data without waiting for real-time studies to complete. The Arrhenius equation forms the mathematical basis of ASTM F1980: a...
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Seal Integrity Testing for Sterile Medical Packaging: Methods and Best Practices
Key Takeaways Seal integrity testing verifies that the seals of a sterile barrier system are free of defects that could allow microbial ingress, and is a mandatory element of ISO 11607 packaging validation. Testing methods divide into destructive (dye penetration,...
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