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Old 12th January 2018, 11:43 AM
chris1price

 
 
Total Posts: 234
re: Gamma Irradiation - dose audit and source replenishment

Hi, I'll try to answer your questions, however i recommend reading section 10.2 of 11137-2 very carefully.

The dose audit can be thought of as a verificaton that nothig has changed in the product or processes. For Method 1, you select 110 pieces. you perform bioburden on 10 pieces. If the results are ok, sterilise the remaining 100 at the verification dose and test for sterility. You are allowed up to 2 positive results. The standard explains what to do if you get positive results.

Yes this has to be done every quarter. Once you have good data, the period can be increased to 12 months - take a look at 11137-1 section 12.1.3.2

This is one of the major issues with Method 1, testing 110 pieces every quarter can get expensive and time consuming. a VDMax method only uses 20 pieces.

When they change the radiatoin source, you should only need to redo the dose mapping. I do not think there is any need to do PQ or other tests.

Chris
Thanks to chris1price for your informative Post and/or Attachment!

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