Package Integrity Test ASTM F 2096 or ASTM 1929

mpfizer

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#1
Hi,
we manufacture orthopedic implants and use tyvek pouches to pack them we have two pouches one over the other for sterile application. We gamma sterilize them .
Which is the correct test method to follow form the above ...can water immersion test be done ?? . We have normally been blue doing dye penetration test as per astm .
1929 . and have not had any negative results .

Thanks
michelle
 
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ECHO

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#2
Hello,

Both the bubble and the dye penetration test evaluate the sterile barrier from external forces. However, the two test for different things.

While the bubble test evaluates the entirety of your packaging, the dye penetration test only evaluates the seals.

If your goal is to use one of these test as your verification, I would recommend that you prioritize the bubble test over the dye penetration test. Running both is also not a bad idea.

As for what test "can" be done on your packaging, it will depend on the packaging. ASTM 1929 was written to be used only on porous packaging. I believe ASTM F3039 is for non-porous packaging.

I hope this helps.
 
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