Validation process

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. Validation of the package designs and packaging process requires the use of test methods, which must also be properly validated following the requirements of EN ISO 11607.

Design and process validation are often combined in an effort to mitigate the validation costs. In practice this means that validations will be performed sequentially, using samples from a validated process for design validation. When doing so, it is important to structure testing properly so that any failures can be investigated and any retesting is minimised.

Design validation

Design validation includes performance testing, process inspection and testing, stability testing and usability evaluation.

Process validation

According to the essential requirements of the medical device directive, devices delivered in a sterile state must have been manufactured and sterilized by an appropriate, validated method. According

Validation flow diagram

The picture above is just an example of a combined validation study.  Other flows are possible.

Test method validation

The SBA has prepared a guidance document on test method validation. Test methods need to be validated to demonstrate that they are fit for their intended purpose and that the results they provide are

Revalidation

Validating a sterile barrier system (SBS) is a process that involves four different types of validation activities which covers design, packaging process, sterilization, and test methods. In order to

Relevant test methods

A list of relevant standards to ensure SBS compliance.