Medical Device Packaging Testing

Medical device packaging must protect the device and maintain sterile barrier during storage and transportation. There are different packaging materials that are compatible with various sterilization methods. SteriLabs offer extensive packaging solutions to help our clients deliver safe and effective products.

Medical Device Packaging Testing

Medical Device Packaging Validation

SteriLabs offer packaging testing and validation services per international standards and regulatory requirements. The package validation includes specifications, materials qualification, sterile barrier testing and failure analysis.

Medical Device Packaging Testing

Sterilization Pouches Seal Integrity Testing

Heat seal peel pouches are commonly used packaging materials for sterile medical devices. One or two sides of the peel pouches are sealed at the healthcare facility using a heat sealer. The quality and integrity of the seals created by the heat sealers are imperative to the sterility of the medical equipment being held inside the pouches.

Seal integrity verification provides assurance that the package is sealed properly, leak-free and secure from outside contaminants. SteriLabs offer seal leak testing of porous medical device packaging using tests designed to detect and locate leaks caused by micro-channels formed between two layers that make up the package.

Medical Device Packaging Testing

DPSL-75™ Dye Penetration Kit

DPSP-75 Dye Penetration Kit includes the test solution that is ready to go right out of the bottle and the kit includes a reference guide so you can quickly evaluate and identify seal failures. The DPSL-75 is small and portable so additional kits can be purchased to ensure you stay compliant and test your medical pouch seal quality produced by all heat sealers in your facility.
DPSL-75 Dye Penetration Kit;

  • 1 – 75 ml bottle of ready to use testing dye
  • 20 – disposable droppers
  • Instructions for proper use and interpretation of results as per ASTM F1929

For more information, please Contact Us.

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