ASTM F1929 dye penetration test - Validation for in-house testing

Wolf.K

Involved In Discussions
#1
Hi,

I wonder if anyone else ever validated ASTM F1929 for use in an in-house lab? I think I need some advice, e.g. about the number of replicates by each experimenter, and the number of experimenters, and else...

Truly yours,
Wolf...
 
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SHernandez

Team Lead II - Biomedical innovation
#3
Hi Wolf,

I've been wondering the same thing, I heard that the ASTM test methods are considered validated but I'm looking for written confirmation of that.
I hope someone out there has an answer,

Thank you in advance,

Seb,
 

Wolf.K

Involved In Discussions
#4
I heard that the ASTM test methods are considered validated but I'm looking for written confirmation of that.
Unfortunately, ISO 11607-2-2019, p.6, chapter 4.4 Test methods, 4.4.3 "All test methods to show conformity to this document shall be validated and documented by the laboratory performing the test. Note: Annex B contains a list of test methods. Publication of a method by a standards body does not make it validated in any laboratory".

So, for in-house testing of ASTM F1929 I have to validate the test. At the university I never (!) learned anything about validation and verification. I have been working in basic research for about 20 years, in several different university laboratories, but never ever any professor validated any method or wanted it be validated. If a new method was introduced, we put up the setup, run a couple of tests (n=3 to n=10) to familarize with the method, then we used it. Similarly, all lab balances were calibrated in house with sample weights which had never been calibrated, or had been calibrated 30 years ago. Nor did anyone ever calculate uncertainty budgets. SD was calculated, that's it. Was good enough for publication. Nowadays I wonder, how could we ever develop some kind of civilization? ;-)

So, back to F1929. First I have to validate the method, then I have to calculate the sample size for the test for each batch. For validation, somewhere I found the sample number 32 for each of the test users.

Anyone here who has validated F1929 for in house tests and could comment on this issue?

Truly yours, you will have my eternal gratitude!
 

indubioush

Quite Involved in Discussions
#5
Not to make things more complicated but the dye test is not the best. Bubble test is usually chosen over the dye test. I suggest you work with an external supplier who specializes in these type of tests. You can ask them if they validate the tests at their facility. Some providers are Westpak, DDL, Tektronix.
 

Wolf.K

Involved In Discussions
#6
Not to make things more complicated
That's what we currently do - send them away. What I want to understand is, how to validate such a test, dye test, bubble test, the test itself is not important, it is the way to validate a test listed in 11607-2. E.g., the dye test is used at dentist labs to test the seals of packaging of equipment to be autoclaved. You can buy ready-to-run dye kits; for the validation you just have to train your staff, fill out some sheets, and send three (3) newly sealed pouches to the 17025-certified test laboratory selling the kit. How did they calculate a sample size of three (3)? I mean, if you do a risk assessment and then you have confidence interval and reliability requirements and calculate a sample number - three samples is something next to no sterility at all, or am I wrong??
 

Wolf.K

Involved In Discussions
#7
Another example, from DuPont and Tyvek pouches:

https://www.dupont.ca/content/dam/d...e-package-testing-case-study-part2-metric.pdf

For ASTM F1929 they use 15 unfilled, non-sterilized blisters, and 15 filled blisters each sterilized by EO and Gamma radiation (=45 blisters total).
They use attribute data (pass/fail), and statistical power 90% and confidence level 90%. With 90/90 I get a sample size of 68. Not 15, not 45, not 3 (see above).

Also, when I validate a test method, I don't know the batch size which will later on be the source of the test items.
 

indubioush

Quite Involved in Discussions
#8
I feel like you are blurring the line between test method validation and validation of sterile barrier systems.

To validate your sterile barrier system, you first need to see if the method you selected will work. (This is test method validation.)
Let's say you want to do the bubble test to validate your sterile barrier system. Here are the steps you take:

1. Obtain material that already has a validated seal, n=10. (You cannot use your own packaging because your sterile barrier is not validated yet.)
2. Use 8 of the 10 items to make bad seals of varying degree (e.g., pin prick to tear). Number all 10 items.
3. Test repeatability by having one operator repeat the test 5 times using one seal item with pin prick. (The breach should be detected 5 times.)
4. Test reproducibility by having two operators test all 10 seals. (Results should be the same regardless of operator.)
5. Calculate sensitivity by counting the number of bad seals that were correctly identified as bad.

If you do the above, and you get the results you were expecting, you method is now validated and you can use this method to test your own seal (validation of your sterile barrier).
 

indubioush

Quite Involved in Discussions
#9
Also, when you go on to validate your sterile barrier, the sample size for this validation will depend on the level of risk if the sterile barrier should fail.
 

Wolf.K

Involved In Discussions
#10
I feel like you are blurring the line between test method validation and validation of sterile barrier systems.
(...)
1. Obtain material that already has a validated seal, n=10.
Yes, I know, but in both cases I need to calculate the sample number. Now, you write n=10. This is quite common. But I never found a reference for this sample size. The Dupont example uses 15 samples, and I cannot find a calculation to end up with 15 samples. Originally, I was looking for some directions for test method validation according to ISO 17025, and I thought, that ASTA F1929 is a simple test, used by many companies, therefore it should not be difficult to get the information. But this seems to be kind of magic science...
 
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