Packaging Validation

Medical device packaging validation is a comprehensive procedure that evaluates the effectiveness and quality of packaging equipment, materials and designs used for medical devices, as well as processing variables that affect the ability of a packaged device to meet its acceptance requirements.

It involves a series of tests and assessments to ensure that the packaging meets regulatory requirements, industry standards, and manufacturer specifications. The ISO 11607 series of standards defines the validation requirements applicable to packaging systems.

Medical device directives and regulations require that medical device packaging materials and systems comply with the requirements of the ISO 11607 series of standards, packaging for terminally sterilized medical devices.

The aim is to preserve the sterility of medical devices, protect their functionality and preserve their biological safety. It is therefore crucial that the packaging is properly validated according to the packaging validation standard.

Test Strategy document is a well-described document in packaging testing which clearly defines the exact packaging validation testing approach and goals of the testing project.

The test strategy document addresses all questions about what is required by the medical device regulation and how plan to do it to comply with regulatory requirements.