AFTER TERMINAL STERILIZATION OF LVP PRODUCT WHAT POSSIBLE CAUSES FAIL THE STERILITY TEST OF PRODUCTS EXCEPT LABORATORIES POSSIBLE CAUSES… BECAUSE OUR PRODUCT STERILIZATION AT 108°C FOR 60 MINT
SECOND OUR AUTOCLAVE VALIDATED BY BI INDICATOR COMPLIES…
Hello! In addition to using a proper quality tool is used for root cause analysis, I would suggest the following:
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Do you have information abobut the product bioburden before sterilization, and the lethality (F0) ahieved in that cycle? Perhaps the bioburden was higher or more resitant to what an F0 of 3 min can effectively sterilize, considering that an F0 of 3 min is fairly low.
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You could take an expanded leak test sampling to ensure that sterility was not caused by leaks in the container-closure system of the product (product failure)
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You could take an expanded sampling of products that were located next to or in the same position as the ones that failed sterility, to see if thay also present growth. This would suggest a process failure and/or a potential cold spot in the autoclave.
If you have more info about the bioburden, autoclave design and parameters, it could lead to a better understanding of the process and could pinpoint the root cause more effectively.
I hope this is useful.
Thank you sir