發(fā)酵罐滅菌驗(yàn)證方案(英-資料下載頁
2024-11-10 17:01本頁面
【導(dǎo)讀】protocol.vessel.SOPQ002-GramStaining.Culturetubes,inoculatingloops,bunsenburners.validationplan.
【正文】 ors initials. Store at 40C until delivered to QC laboratory. Autoclave Bioreactor according to SOP Remove fermentation vessel from autoclave and allow to cool to room temperature inside the Biological Safety cabi. Collect a 15 ml sample from the autoclaved fermentation vessel as described in SOP P005. Label this sample “post autoclave” with the date and time and collectors initials. Store at 40C until delivered to QC laboratory. ___________________________________End of Page 5________________________________ The Northeast Biomanufacturing Center amp。 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_______________________________
畢業(yè)設(shè)計(jì)相關(guān)推薦
鄂ICP備17016276號(hào)-1