发酵罐灭菌验证方案(英

发酵罐灭菌验证方案(英内容摘要：

supervise the described validation exercises in accordance with the validation schedule, in response to replacement or modification to autoclaves used for the purpose of sterilizing fermentation vessels, or, in response to modification or replacement of SOP P002, P003, or P004. It is the responsibility of the Production Department to perform the described validation exercise and to deliver samples to the Quality Control Department for analysis. The Quality Assurance Department will review all validation data generated in response to this validation plan and will have final signoff on all validation certification. 6. Hazard Communication: Fermentation Vessels, if not properly vented, may build up sufficient pressure during the autoclave process to explode. All personnel should wear appropriate safety clothing when removing fermentation vessels from the autoclave. Autoclaved liquids may boil over and leak from the fermentation vessel. All personnel should wear appropriate safety clothing when removing fermentation vessels from the autoclave. 7. Attachments: Validation Data Sheet ________________________________End of Page 3_______________________________ 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 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. Thaw the frozen vial on i。