【正文】 Name / Signature / Date Reviewed By:______________________ Name / Signature / Date Approved By:______________________ Name / Signature / Date 1. Scope: This document covers validation of the fermentation vessel sterilization process as described in SOP 004 –Preparation of BioFlow 110 3 liter fermentation vessel. Validation of the bioreactor sterilization procedure is conducted in order to provide documented evidence that the process described in SOP P004 will effectively sterilize growth media contained in the New Brunswick Scientific BioFlow 110 3 liter fermentation vessel and kill any microanisms inadvertently introduced into the fermentation vessel during the preparation of media and the vessel. 2. Definitions: NBS – New Brunswick Scientific CFU Colony Forming Units CFU/ml – Clolony Forming Units per milliliter rGFP – Rebinant Green Fluorescent Protein . H2O – Deionized water LB – Luria Bertani media ml(s) – Milliliter(s) (103 Liters) – Optical Density at 600 nanometers μl – microliter (106 Liters ) Bioreactor / fermentation vessel are used interchangeably throughout this protocol. _________________________________End of page 1______________________________ 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 2 of 6 3. References: Guide to Operations: BioFlow 110 Modular Benchtop Fermentor Manual M1273 0054 Revision E Guide to Operations: AMSCO Eagle Series Autoclave Model 3011 Revision SOP P001 Cleaning of NBS Bioflow 110