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【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 5 of 6 Preparation of Bioreactor Prepare the NEB BioFlow 110 3 Liter vessel as described in SOP P002. Prepare 2 Liters of LB liquid media as described in SOP P006. Add the LB Liquid media to the fermentation vessel. Collect a 15 ml sample from the autoclave as described in SOP P005. Label this sample “preinoculation” with the date and time and collectors initials. Store at 40C until delivered to QC laboratory. Inoculate the fermentation vessel with 50 mls of culture obtained from step Close the fermentation vessel and agitate for 10 minutes at 500 rpm. Collect a 15 ml sample from the autoclave as described in SOP P005. Label this sample “postinoculation” with the date and time and collectors 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 ProtocolFermentation Vessel Sterilization Subject: Validation Protocol for sterilization of BioFlow 110 3 Liter Bioreactor. Document : VP001 Revison: Effective Date: January 1, 2020 Page 1 of 6 Prepared By: T. Burkett_____________________
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