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Package Integrity Testing Acceptance Criteria

H

HPulaski

#1
Hello All,
Our company is currently using a medical band sealer to seal tyvek pouches for class 1 and 2 devices, we currently sterilize via EO.

I have been working within ASTM Standard F1140-07, Internal pressurization failure resistance of unrestrained packages, and have ran into a complication.

The standard requires that you test your pouches to failure, and you are able to use a blocking agent when needed to reach seal failure. Unfortunately, many of our pouches have a very large surface area, and we have not been able to 'fail' some pouches.

Due to the fact that we purchased our quality system from a previous company, we currently have a reference formula in place that combines perimeter, surface area, etc. to provide acceptance criteria for the burst value of the pouch, we currently test our pouches to the value determined by that formula. Long story short, we are not able to validate this formula.

I am looking for guidance in pouch testing. Obviously, you prefer to test to failure per the ASTM standard, but how do you determine the acceptance criteria of the pouch failure? (I.E. if the pouch 'fails' at a value of 2 inH20, and it sees a value higher than that in sterilization, obviously 2 inH20 would not be acceptable) Is this based on sterilization, or some other factor.

Any help is appreciated. Thanks!!
 
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v9991

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#3
while the experts pitch-in to address your query...let me fill in the gap...
just in case if you have not explored these links and if its relevant and usefull...

Optimizing Package Design for EtO Sterilization
http :// www. mddionline .com/article/optimizing-package-design-eto-sterilization- DEAD 404 LINK UNLINKED

http :// www. tga. gov .au/pdf/presentations/presentation-pdaa-120918-longstaff.pdf- DEAD 404 LINK UNLINKED

http ://www. epa .gov/ttnatw01/eo/eoguide.pdf- DEAD 404 LINK UNLINKED

http :// www. cdc. gov/hicpac/pdf/guidelines/Disinfection_Nov_2008.pdf- DEAD 404 LINK UNLINKED
 
Last edited by a moderator:
H

HPulaski

#4
Thank you for the links! I have not explored these sites, but briefly looking them over, they look like they will be helpful! Thanks again :)
 
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