Gamma Quarterly Audit

[Balachander]

Hi all,

We have couple of products which are sterlized uisng Gamma. The initial validation was done using VDMax22.5 and verification doses are defined for quarterly audits. We are planning to move to VDMax 25 now as suggested by a sterilization professional. I just want to know what is the process to change from VDMax 22.5 to VdMax 25 ?
Do we have to perform initial validation and determine the verification doses ? Or just use the same verification doses established and perform quarterly audit with Vdmax 25. Can someone clarify here

Thanks !

 

[planB]

Bachalander,

since you change the dose you aim to substantiate, also your verification dose changes. So you will have to repeat your initial dose-substantiation experiments. You might be in a position to not have to re-determine your bioburden levels over three lots in case you did not change related manufacturing processes.

Food for thought: is there any real technical reason to change your validated / substantiated irradiation dose of 22.5 kGy?

HTH,