Yinso Packing Shares Five Key Considerations for Medical Device Packaging Evaluation

A study by the US FDA on defect identification revealed that over 50% of recalls involving sterile medical devices are related to the quality of their packaging. In our daily registration evaluations and inspections, we found that many manufacturers lack sufficient attention and understanding towards the final medical device packaging. For instance, they tend to adopt the same packaging as others without knowing how to select suitable materials or what specific evaluation projects to carry out.

Below, the Yinso Packing team has compiled a few considerations for packaging evaluation, for reference only.

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

Physical and chemical properties, biocompatibility, interaction with the device, etc.

2.Performance Evaluation of Primary Packaging:

Seal continuity, seal width, seal strength, package integrity, peelability without debris, etc. Evaluations should be conducted both before and after sterilization.

3.Primary Packaging Process Validation Report:

Including IQ, OQ, and PQ for equipment processes. Clearly define sealing process parameters (e.g., temperature, pressure, and time).

4.Primary Packaging Shelf-Life Validation:

Generally, accelerated or real-time aging is acceptable. If accelerated aging and real-time aging validation results are inconsistent, real-time aging validation shall prevail.

5.Primary Packaging Transportation Simulation Evaluation:

Generally includes transportation, vibration, and drop tests.

Lastly, remember that for primary packaging materials that directly contact the use surface of terminally sterilized medical devices and are ready for use without cleaning, the cleanliness level of their production environment should follow the same principles as the product production environment.