What's the Membrane Integrity
What's the sterile grade filter
lSterile grade filter: refers to the filter’s effective filtration area per square centimeter under the technological conditions, and can intercept 107 CFU of（colony forming
unit) defective pseudomonas Brevundimonas diminuta(ATCC 19146).
sterile grade filters include:pes/ptfe/pvdf/nylon/....
lDefinition given by American society testing materials ASTM F838-83 (1993): sterile grade filter refers to the filter that meets the following standards: challenge the filter with defective pseudomonas per square centimeter (107cfu), and the downstream liquid is sterile .
lDefine whether is sterilization level: according to the microbial closure capacity of the filter, complete the corresponding standard method confirmation and process validation.
Why need do integrity Test?
Aseptic process and validation requirements lConfirm the correct filter pore size; lDetect the leakage of O-ring, sealing ring; lConfirm the integrity after sterilization.