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Old 12th January 2018, 02:31 PM
htcoztrk

 
 
Total Posts: 12
re: Gamma Irradiation - dose audit and source replenishment

Thank you for your replyChris. I'll check again carefully your reffered clauses of standard.

Meanwhile I have another question that I think you may have an answer. We have two product sterilized by gamma. Since the materials are different we performed two validation. I already completed bioburden test for 10 units from a batch and determined the avarage level for both of them. However it's been 40 days since product 1 and 20 days since product 2 and I did not send out any goods for irridation&sterility testing because I was thinking bioburden is enough. But we released some batch of goods because average bioburden levels was appropriate. Do I need to initiate a recall?

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