Key Considerations for Final Medical Device Packaging Review

FDA defect identification studies indicate that over 50% of recalls involving sterile medical devices are related to medical device packaging quality issues. In our daily registration reviews and inspections, we have observed that many manufacturers lack sufficient awareness and understanding of final medical device packaging. Common issues include blindly following competitors' packaging choices without understanding how to select appropriate materials or how to conduct proper evaluations, including which specific tests are required.

Here are several key points to note during the packaging review process, for reference only:

1. Evaluation of Sterile Barrier System (Primary Medical Device Packaging) Materials:

- Physical, chemical, and biocompatibility properties

- Interaction with the device

2. Performance Evaluation of Primary Packaging:

- Seal continuity, seal width, seal strength, package integrity

- No particulate shedding upon seal peeling

- Testing should be conducted both before and after sterilization

3. Process Validation Report for Primary Packaging:

- Includes Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ)

- Must specify sealing process parameters (e.g., temperature, pressure, time)

4. Shelf-Life Validation of Primary Packaging:

- Accelerated or real-time aging studies are generally acceptable

- If results from accelerated and real-time aging differ, real-time aging data shall prevail

5. Transport Simulation Testing for Primary Packaging:

- Should include transportation, vibration, and drop testing

Finally, it is critical to note that primary packaging materials that come into direct contact with the sterile surface of terminally sterilized medical devices (and are used without prior cleaning) must be manufactured in an environment with the same cleanliness level as the product manufacturing environment.