Ageing, Transit and Packaging Testing

Comprehensive Ageing, Transit and Packaging Testing Services

Packaging validation is essential for all sterile medical devices to ensure the sterile barrier remains effective throughout claimed lifetime and transportation.

This is demonstrated through seal strength and seal integrity testing of the packaging. Ensuring the safety and integrity of medical devices during transportation is also crucial for maintaining their sterility and functionality.

Transit and packaging validation assesses the stability and integrity of medical devices during transportation, ensuring they remain functional, and the sterile barrier is intact upon arrival. Accelerated ageing allows the assessment of the claimed-lifetime in a much short time frame, although the accelerated data can be backed up with real-time ageing.

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Our Ageing, Transit and Packaging Testing Services

Accelerated Ageing:

ASTM F1980 – Standard Guide for Accelerated Ageing of Sterile Barrier Systems and Medical Devices
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Transit Simulation Testing:

ASTM D4169 – Performance testing of shipping containers and systems
ASTM D7386 – Performance testing of packages for single parcel delivery systems
ISTA 3A – Packaged products for parcel delivery system shipment (70kg/150lb or less)
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Packaging Testing:

ASTM F1886/F1886M – Visual inspection for flexible packaging
ASTM F88/F88M – Seal strength of flexible barrier materials
ASTM F1140/F2054 – Burst testing of flexible package seals
ASTM F1929 – Detecting seal leaks in porous medical packaging by dye penetration
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Medical devices are often sensitive, complex, and critical to patient care. Any damage or loss of integrity to the sterile barrier during transit or the claimed lifetime can compromise their functionality, leading to potential health risks and regulatory non-compliance.

We offer a comprehensive suite of transit testing and packaging validation services tailored to the unique needs of medical devices as well as state-of-the-art accelerated ageing equipment. Our services adhere to industry standards including ISO 11607-1 & -2, MDR and FDA guidance.

ISO 11607-1 – Packaging for terminally sterilized medical devices – Part 1: Requirements for materials, sterile barrier systems and packaging systems, addresses the packaging requirements for medical devices to ensure sterility is maintained.

Every medical device is unique, and so are its transit and packaging needs. We work closely with our clients to develop customised testing protocols that capture the specific requirements of your products and your needs.