ISO 11607-1 Packaging system validation

[Leona]

Hi, I have a question regarding the microbial barrier testing.
Does microbial barrier testing need to be performed after packaging stability testing? The microbial barrier is tested by manufacturer of the package material, is not this enought? And what about sterility test? Could be the sterility test proof, that the microbial barrier of the SBS is OK?

 

[planB]

You may want to look into ISO 11607-1:2019, section 8. 1 - quote:

Sterile barrier system integrity testing may be performed by testing the integrity of the materials and the integrity of the seals and closures separately.

So typically, you choose tests, that demonstrate seal-integrity and whole-package integrity of the sterile barrier system (SBS) during your stability study. Microbial barrier properties of materials according to ISO 11607-1:2019, section 5.2 may indeed be certified by you material supplier, but are only a necessary input for your stability study.

Test of sterility as proof of the continued barrier properties of your SBS has been done in the past and still can be done, but is typically replaced by more state-of-the art physical integrity testing.

HTH,

 

[Leona]

You may want to look into ISO 11607-1:2019, section 8. 1 - quote:

So typically, you choose tests, that demonstrate seal-integrity and whole-package integrity of the sterile barrier system (SBS) during your stability study. Microbial barrier properties of materials according to ISO 11607-1:2019, section 5.2 may indeed be certified by you material supplier, but are only a necessary input for your stability study.

Test of sterility as proof of the continued barrier properties of your SBS has been done in the past and still can be done, but is typically replaced by more state-of-the art physical integrity testing.

HTH,

Just to clarify..

If I use the Dye migration test (only the seals), than I have to perform another test to proof the integrity of the material?
If I use for example the Bubble test (integrity of whole-package), than I do not need to proof the integrity of the material, right?

Thank you

 

[planB]

Yes, you typically perform at least one seal-integrity test (which could be a dye-penetration test as you suggest) and one whole-package integrity test (which could be a bubble-emission test as you suggest) for each testing time point during your stability study.

 

[erdal88]

Hello. We created a test plan for Class-2 medical device design packaging in order to be convenient in terms of MDR necessity. Transport and stability(accelerated aging and real-time aging) tests will be performed. In the scope of SBS testing; Dye penetration(seal integrity), bubble test(whole package integrity), seal strength test, peel test, label integrity test, and microbial barrier tests will be performed after the stability and transport test. The microbial barrier was already tested by the supplier, but we are testing the packed product to be sure to see if the effect of microbial barrier properties for Tyvek is still proper after stability and transport testing.

 

[Leona]

Hello. We created a test plan for Class-2 medical device design packaging in order to be convenient in terms of MDR necessity. Transport and stability(accelerated aging and real-time aging) tests will be performed. In the scope of SBS testing; Dye penetration(seal integrity), bubble test(whole package integrity), seal strength test, peel test, label integrity test, and microbial barrier tests will be performed after the stability and transport test. The microbial barrier was already tested by the supplier, but we are testing the packed product to be sure to see if the effect of microbial barrier properties for Tyvek is still proper after stability and transport testing.

Can i ask you how many samples do you plan to use for each test?

 

[erdal88]

For attribute tests 59 samples, for the variable tests 10 samples (%95 confidence, %95 reliability- it comes from impact level according to DFMEA)
Since some tests are non-destructive, a total of 79 samples is needed for each test. (Stability, transport)(79 + 79 )

 

[Vinu Raghav]

Hi Experts,

Apologies if i cut the thread

Is there any packaging validation criteria for periodic revalidation?
If any could you please provide a reference?

Thanks in advance

 

[planB]

You may want to have a look into ISO 11607-1:2019, sections 9.3, 94 and 9.5.

 

[Vinu Raghav]

Thank you.

in the mentioned reference, revalidation required only when the changes in existing product / validation
Is there any recommended timeline for revalidation if there is no changes have been made in original validation?