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Packaging validation: ISO 11607 and ASTM

Konmex Laboratories provide services of medical device packaging validation in compliance with appropriate ASTM standard methods and ISO 11607 “Packaging for terminally sterilized medical devices”.

We conduct various tests to determine package integrity for porous and non-porous materials, among which the most common are:

  • Bubble emission Test ASTM F2096
  • Dye Migration Test ASTM F1929
  • Seal Peel Test ASTM F88

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