Frequency of Bioburden Testing

P

Philipp

#1
Hello everyone,

I work in quality management for a medical device company and we produce class 3 implants. We have products which are gamma-sterilizied as well as products which are EO-sterilized.

My question is about the bioburden testing of the products.

- Do I have to do a bioburden testing for each batch?
- Or is there the possibilty to do some kind of process validation to reduce the frequency to 3 times a year for example?
- Is there a difference between gamma and eo sterilization?
- Does it makes a difference if the products are for the us or the european market?

At the moment we have some discussion with the production department about quality testing and costs, therefore it would be very helpful for me if you can also name the relevant regulations.

Thank you very much:thanx:
Philipp
 
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M

MIREGMGR

#3
- Do I have to do a bioburden testing for each batch?
- Or is there the possibilty to do some kind of process validation to reduce the frequency to 3 times a year for example?
You have to assure that your sterilization process remains valid. That means, among other things, that you have to know what product and process characteristics and parameters may change, determine if they have changed, and assure that the effect of a change is acceptable. This would include quantifying and microbiologically characterizing your bioburden level if it's changed, or you have reason to believe it may have changed, for any reason.

This assumes that your sterilization runs are frequent. Technically, you only have to manage validity of your sterilization process with the same frequency as you use that process, ahead of each run.

You additionally have to conduct a periodic desk review of your sterilization process--the usual recommendation is at most annually--and a periodic re-qualification "whether it's needed or not". The standards don't establish a fixed re-qualification frequency; we've been told three years at the most for an ISO 11135 process by a microbiological auditor for a large, well reputed NB, but ANSI/AAMI TIR16...which is a guidance, and has uncertain authority with EU regulators...recommends two years at most, in section 6.2. My view is that these frequencies should be based on how rigorous your knowledge is of the non-variability of every aspect of your product and processes.

- Is there a difference between gamma and eo sterilization?
Yes in regard to the specific standards and guidances, of course. No in regard to the general concepts above.

- Does it makes a difference if the products are for the us or the european market?
On the US side, you may be expected to conform to AAMI guidances, or at least to provide a pretty substantial rationale for an alternate approach. On the EU side, it'll depend on your NB's approach. My experience has been that rigorous NBs and US FDA tend to be pretty much on the same page, even though they may document things differently.
 
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