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發(fā)酵罐滅菌驗證方案(英(文件)

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【正文】 BioFlow 110 Modular Benchtop Fermentor 3 Liter vessel. SOP P004 –Preparation of NEB BioFlow 110 Modular Benchtop Fermentor 3 Liter vessel. SOP P005 – Collection of Inprocess samples from NEB BioFlow 110 Modular Benchtop Fermentor 3 Liter vessel. SOP Q001 – Determination of the number of viable bacterial cells through serial dilution and growth on LuriaBertani media. SOP Q002 Gram Staining. SOP P006 – Preparation of Luria Bertani liquid media. SOP P008 – Determination of the Optical Density of a bacterial culture 4. Reagents: 70% Isopropyl alcohol Sample collection vials LB liquid media Bacillus subtilus culture Culture tubes, inoculating loops, bunsen burners. _____________________________________End of Page 2 _______________________________ 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 sam
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