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Radiation Sterilization Dose Audit: Bioburden frequency

B

Baliraun

#1
Hello all :bigwave:

How often do we have to do Bioburden testing after we've increased our radiation sterilization dose audit intervals to 12 months? Can we do the bioburden testing every year as well? Or should we be doing bioburden every 3 months while doing sterilization dose audit every 12 months?

A little background: we've increased our frequency of sterilization dose audits from 3 months to 6 months to now 12 months.

We've also shown our stability of bioburden levels for the past years: 0.0 - 0.1 CFU.

Per AAMI/ANSI/ISO 11137-1

12.1.3.2 An increase in the interval of time between the performance of sterilization dose audits shall be permitted if

a) at least four consecutive sterilization dose audits, whose outcomes have required neither dose augmentation nor sterilization dose re-establishment, have been performed at the previously selected interval of time;

b) data are available that demonstrate the stability of bioburden within the bioburden specification over the same period of time as item a) above; these include

1) bioburden determinations performed at least every three months and

2) characterization of bioburden ...


Thank you!
 
Elsmar Forum Sponsor

planB

Super Moderator
#2
Baliraun,

refer to section 12.1.2.2 of ISO 11137-1:

the maximum interval of time between determinations of bioburden shall be three months.
So, no you cannot lower the frequency of bioburden determinations, unless section 12.1.2.4 applies (i.e. manufacturing frequency lower than quarterly).

HTH, Gerhard
 
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