During revalidation if couple thermocouples do not reach predetermined temperature and this is genuine failure how do you risk assess the impact on sterile product ? Any thoughts please share.thank you
Hi, Thriveni
There could be a lot of different approaches to assess the impact on sterility, but one that you must include always is to address the Sterility Assurance Level (SAL) that was met in that cycle.
To do this, you must claculate how much lethality (F0) did the product accumulate at the end of the cycle, and see if that F0 is sufficient enough to achieve a SAL of 10^-6 (probability of 1 in a million to geta non-sterile unit, also called PNSU). This, however, must be verified with a biological challenge. This is why it is very common for manufacturers to perform a cycle validation challenging those conditions (in this case: low temperature) so that you can have objective evidence that even with that low temp, you still demonstrated an SAL of 10^-6 as indicated by regulations.
One thing that you must not do, is to base your rationale for the impact only on samples taken for sterility testing, this is explicitly indicated in the USP <1229>:
Sterility, therefore, is defined in probabilistic terms that establish an acceptable level of risk. Sterility can be accomplished only by the use of a validated sterilization process under appropriate current good manufacturing practices and cannot be demonstrated by reliance on sterility testing alone.
I hope this helps.
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