How do you validate medical device packaging?

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Packaging validation is complex. There are several processes that must be completed

  1. The manufacturing process to produce the packaging’s sterile barrier system must be validated. This requires an Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) to be conducted on the manufacturing equipment.
  2. Packaging performance testing must be completed. This includes manufacturing and sterilizing under worst-case conditions and subjecting the packaging system to simulated distribution testing.
  3. A stability study must be completed and is typically done with both accelerated and real-time aging studies.
  4. Both the performance testing and stability study require tests for seal integrity and seal strength as well as an evaluation of product protection.