The key functionality of packaging for terminally sterilised medical devices is to allow for sterilisation and to maintain sterility until the point of use in a healthcare setting. Package designs must be validated (qualified), and the packaging process must be validated and controlled. Validation requires the use of test methods, which must also be properly validated as well following the requirements ofย EN ISO 11607.

Design and process validation are often combined in an effort to mitigate the validation costs. When doing so, it is important to structure testing properly so that any failures can be investigated and any retesting is minimised.

Design Validation

Performance Testing, Stability Testing, Usability Evaluation and in process inspection and testing.

Process Validation

IQ (Installation Qualification), OQ (Operation Qualification), PQ (Process Qualification)

Validation Flow Diagram

Sample of a typical flow diagram for a validation study to achieve ISO 11607 compliance

Test Method Validation

SBA guidance document on:-
Test Method Validation

Revalidation

Maintaining compliance for a sterile medical device packaging system.

Relevant test methods

List of relevant standards to ensure SBS compliance.

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