Five Key Review Points For Sterile Medical Device Packaging: Half Of All Companies Have Experienced Recalls Due To These Deficiencies!

Data from US FDA defect identification studies serves as a wake-up call for all medical device professionals: over 50% of recalls for sterile medical devices are ultimately related to packaging quality. In routine registration reviews and inspections, we find that many manufacturers do not prioritize final medical device packaging sufficiently and operate under misconceptions—such as blindly following material selection trends, not understanding how to make compatible choices, and being unaware of which specific evaluation items should be conducted.

Although sterile medical device packaging is small, it concerns product safety and corporate reputation. How to conduct packaging reviews systematically and scientifically? The following points are for your reference:

1. Comprehensive evaluation of Sterile Barrier System (primary packaging) materials

extends beyond physical and chemical properties. It also requires investigation of biocompatibility and interactions between the materials and the device (e.g., leachables, adsorption, etc.), ensuring the materials themselves are safe and reliable.

2. Performance verification of primary packaging:

Key indicators must not be neglected either before or after sterilization. These include seal continuity, seal width and strength, packaging integrity, and the absence of particulate matter upon peeling. Remember: All performance aspects must be verified both pre- and post-sterilization.

3. Primary packaging process qualification:

IQ/OQ/PQ – not a single step can be omitted. Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) must be completed. Sealing process parameters (e.g., temperature, pressure, time) must be clearly defined to ensure the sealing process is stable and controllable.

4. Shelf-life validation for sterile medical device packaging:

Accelerated aging ≠ Real-time aging. Although accelerated aging testing is commonly used, any discrepancy with real-time aging results must be resolved in favor of the real-time aging data. Conclusions regarding shelf-life must be treated cautiously, avoiding over-reliance on accelerated testing.

5. Transport simulation testing:

Simulate reality, but be stricter than reality. Testing should include various types such as vibration, drop, and compression, simulating extreme situations potentially encountered during actual logistics, to ensure the packaging maintains its barrier function and integrity post-transport.

A final crucial reminder: Primary packaging that contacts the surface of a terminally sterilized medical device directly and is used without prior cleaning must be manufactured in an environment with the same cleanliness level as the product manufacturing environment. This is an absolute red line.

Sterile medical device packaging is not merely "packaging"; it is the critical safety barrier maintaining the sterile state of the product. Systematic review and rigorous validation represent a truly responsible attitude towards both the company and the end-users.

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Five Key Review Points for Sterile Medical Device Packaging: Half of All Companies Have Experienced Recalls Due to These Deficiencies!

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