生物反应器课件 Different cell properties Select cell culture method.ppt

Agitation Agitation - turbine impeller For unaerated water @ 20 C in a fully baffled tank the following formula applies: P= 4.5 x 10-13 * Di5 * N3 * F Di = Impeller Diameter in Inch N = RPM of Shaft F = One (1) for one impeller (1.8) for two impellers (2.4) for three impellers Agitation - turbine impeller Tip Speed should also be considered because of tendency to shear cells. Do not exceed 1 m/s for cell culture And 5 - 6 m/s for microbial cultures. Bioreactor design considerations Shape ASME Bottoms Hemispherical Bottoms Jacket Design Conventional Dimpled Half Pipe Ports Tri-Clamp, DN, NA-connect, Ingold Type, Flange type Bioreactor design considerations ASME Head(s) Hemispherical Head(s) Temperature control Temperature control Cooling System: remove 50 to 100 Watts/Liter of Volume. Heating Systems: One (1) degree C per minute between 25 and 45 C Spargers Ring Type Single Orifice Sintered Sterility Considerations Killing Rates Dead Legs Fitting Types Piping Considerations Sterility Considerations Critical Elements of Steam Sterilization Time Temperature Moisture Air Removal Sterility Considerations Sterility Considerations – Killing rate F0 = ∫ ti * 10(Ti - 121) / Z F0 = Integrated amount of lethality delivered during a cycle i.e. A cycle with F0 = 17 minutes has a lethality equivalent to 17 minutes at121 C. CIP considerations Sterile Piping should be pitched for drainability. CIP Fluids Detergent Alkaline Acid WFI rinse Clean Steam Circuit for Distribution Sprayballs should be designed to deliver 30 LPM per meter of vessel circumference. Minimum flow rate of 1.5 meter per second for pipe or tubing for effective cleaning. EP surface finishing CIP Considerations Electropolishing Conclusions Many factors involved in bioreactor design Supplier has experience Cell culture aspect determined in RD Questions ? Different cell properties Select cell culture method Content Introduction Cell culture