發(fā)酵罐滅菌驗(yàn)證方案(英(參考版)
2024-11-14 17:01本頁面
【正文】 Collaborative Validation PlanFermentation Vessel Sterilization Subject: Validation Protocol for sterilization of BioFlow 110 3 Liter Bioreactor. Document : VP001 Revison: Effective Date: January 1, 2020 Page 6 of 6 Acceptance Criteria 9. 1 All samples shall be delivered to the QC department on ice and the viable cell count shall be initiated by the QC department within 30 minutes of being taken from the fermentation vessel/bioreactor. Record the results of the viable cell count performed by the QC laboratory for the samples collected and labeled preinoculation, postinoculation, and postautoclaving in the chart below. Vessel number Autoclave and cycle Preinoculation viable cell count postinoculation viable cell count postautoclaving viable cell count Log reduction in viable cell count Calculate the log reduction in viable cells between the post inoculation sample and the post autoclaving sample. Acceptance criteria for this protocol is a 9 log reduction in viable cell count between the post inoculation viable cell count and the post autoclaving viable cell count. ________________________________End of page 6_______________________________ 。 Collaborative Validation PlanFermentation Vessel Sterilization Subject: Validation Protocol for sterilization of BioFlow 110 3 Liter Bioreactor. Document : VP001 Revison: Effective Date: January 1, 2020 Page 4 of 6 8. Procedures: Growth of Bacillus subtillus Assemble materials necessary for the inoculation of liquid cultures (inoculating loop, Bunsen burner, culture tube with liquid media, shaking water bath at 37oC.) Obtain a frozen vial of Baccilus subtilus from the 80 freezer. Record the lot number of the Baccilus subtilus cells.
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