SPMC's FAQs provide guidance for your technical challenges.

Integrity TestingTesting

"ISO 11607 and Test Method Validation"

ISO 11607 states that the test method should be validated. I understand why the bubble test, visual inspection, dye leak need to be validated. But for the seal strength and seal width test, the results depend on the tensile equipment and caliper. These two equipment have been calibrated, so do I need to validate these two tests again?

Last Updated On September 6, 2019

First, let us take a moment to expand on the question. The context is on the topic of validation of a test method (or test method validation). Why do tests that are measured with calibrated instrumentation (infer quantitative or “variable” data) need to be validated from the interpretation that “ISO 11607 states that the test method should be validated”? The question rationalizes that tests (i.e. bubble test, visual inspection and dye leak) are dependent on qualitative observations or “attribute” data, where validation does seem appropriate.

Yes, all test methods must be validated, irrespective of whether it provides variable or attribute data. Validation of a test method includes a determination of its precision and bias against a standard. From an August 2006 MD+DI article by John Spitzley and Nick Fotis, co-chairs of AAMI Packaging Working Group for ISO 11607:

“Section 4.3 covers Test Methods. One of the key requirements of the standard is that all test methods must be validated. This is often mistakenly understood to mean that it is sufficient to use a standard test method that has gone through some sort of round-robin testing and has been accepted by a standards-setting body. However, this is not the case. The requirement is for the specific lab that performs the testing to validate the test method in its lab with its people on its instrumentation. A good approach to documenting this validation is to rerun the studies that first provided the round-robin justification to ensure that the new results are in alignment with the prior data.”1

For additional information, one can reference test method validation guidance document F3263 – 17 Standard Guide for Packaging Test Method Validation. A validation is a documented process for understanding requirements, applying design controls, and confirming that the test method actually performs as intended.

In summary, regardless of calibration or confidence in equipment, test methods need to be validated to ensure that all factors that contribute to variation are considered. This includes equipment, methods and people.

1 Spitzley, John and Fotis, Nick. “ISO 11607: New Standard Clears Up Packaging Confusion.” Medical Device and Diagnostic Industry, August 1, 2006. https://www.mddionline.com/iso-11607-new-standard-clears-packaging-confusion (accessed September 9, 2018)