發(fā)酵罐滅菌驗(yàn)證方案(英(存儲(chǔ)版)
【正文】 iomanufacturing 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 ice for 10 – 20 minutes. Inoculate 2 culture tubes, each containing 10 mls of LB media, with 100 μl of thawed B. subtilus cells for each culture tube. Place the culture tube in the shaking water bath set at 370C. Grow the cells at 370C overnight (minimum of 12 hours). Using the overnight liquid culture, inoculate a 500 ml baffled cultured flask containing 100 mls of sterile LB media with 10 mls of the overnight culture material. Place the inoculated 500 ml baffled culture flask in a 370C shaking water bath. Determine the OD600 of the culture as described in SOP P008. Grow the culture until an of between – is reached. Pool the two 50 ml cultures into 1 baffled shaking flask. ____________________________________End of Page 4_________________________________ 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 M
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