L
Laura Halper
Hi Tara,
I'd like to weight in with Jimmy on this one. There is a big difference between not doing any dose audits for 2 years and having records showing quarterly dose audits have been done on a regular basis with one slip up where it was missed.
Also, note that EVEN IF a quarterly dose audit fails, ANSI/AAMI/ISO 11137-2 allows you to simply augment the sterilization dose, or take corrective action if there was a bioburden spike and then revalidate. The standard does not state that you must call into question the sterility of the product sterilized since your last passed dose audit. It's my understanding that this is because the establishment of the sterilization dose incorporates a large safety margin beyond the verification dose. I have seen where companies have had to augment a dose, and the FDA did not raise any questions when this was reviewed during routine inspection.
In your case, you did not fail a quarterly dose audit, and you have data to support a position that bioburden has been under control, even though not tested on schedule.
That's my view,
Laura
I'd like to weight in with Jimmy on this one. There is a big difference between not doing any dose audits for 2 years and having records showing quarterly dose audits have been done on a regular basis with one slip up where it was missed.
Also, note that EVEN IF a quarterly dose audit fails, ANSI/AAMI/ISO 11137-2 allows you to simply augment the sterilization dose, or take corrective action if there was a bioburden spike and then revalidate. The standard does not state that you must call into question the sterility of the product sterilized since your last passed dose audit. It's my understanding that this is because the establishment of the sterilization dose incorporates a large safety margin beyond the verification dose. I have seen where companies have had to augment a dose, and the FDA did not raise any questions when this was reviewed during routine inspection.
In your case, you did not fail a quarterly dose audit, and you have data to support a position that bioburden has been under control, even though not tested on schedule.
That's my view,
Laura