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Medical Devices Packaging – Validation Best Practices

In this post we summarise some key points of a video on packaging validation best practices, especially for terminally sterilised medical devices.

Jeff Barrett, CEO of J-Pac Medical was interviewed by Etienne Nichols for a Greenlight Guru Podcast. They discussed packaging validation best practices and preventing 510k delays for terminally sterilised medical devices. Mr Barrett stated that the packaging of medical devices, especially sterilized products, is often overlooked and/or left to the “last minute”.

He has particular understanding of ISO 11607-1 and -2 Packaging for Terminally Sterilised Medical Devices, Part 1 of which is about designing the package and Part 2 is about validating the package.

Validation Packaging Fails

He tells us that one third of all packaging validations fail at the lab stage. He explains that a key reason for failure is a lack of understanding of the shipping mode because the entire storage and shipping/transit life cycle has not been thought through.

Validate the whole Packaging System

In particular, he talks about the need to validate the whole packaging system, not just the primary package i.e., the entire packaging may include primary packaging, a shipper box and a carton etc. Medical device manufacturers need to document how the packaging was designed, how it meets user needs. He notes that the FDA have added user testing. The seal of the packaging needs to be validated to show that it maintains a sterile barrier. Also, validation is required to show that the product hasn’t changed, due to transit or aging.

Validate for Worst Case Scenarios

He advises that tests should always be done for worst case scenarios e.g., always test the heaviest, sharpest etc version of the product in that packaging. Also, he advises to think ahead – if in the future it is possible that the packaging system will change e.g., if you start to ship larger volumes and you need to adjust the packaging system, you will need to validate these scenarios also.

See the Video here (83) Packaging Validation Best Practices – YouTube

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