無菌過濾和完整性測試-展示頁
2024-08-22 11:11本頁面
【正文】 uld be recorded in the batch record. GMP對完整性測試的規(guī)定（英國） Australian Code of Good Manufacturing Practice for Therapeutic Goods (1990) Page 65,1617:: Before and after each use of a filtration system (including gas filtration) an appropriate check of system integrity should be made. After use, the system should be reexamined for incorrect assembly. GMP對完整性測試的規(guī)定（澳大利亞） Health Industry Manufacturers Association Washington, . (April 1982) HIMA Document No. 3, Vol. 4 BakterienBelastungsTest Bacteria Challenge Test Generally, a filter is considered to be a sterilizing filter when, after being challenged with x 107 challenge anisms per square centimeter of effective filter area (EFA), the resulting filtrate is sterile. This is sufficient to challenge any oversized pores in the filter because preferential flow would be through oversized pores. ... Pseudomonas diminuta (Brevundimonas diminuta) (American Type Culture Collection (ATTC) 19146 is monly used. ... HIMA對完整性測試的規(guī)定 ASTM F 83883, 1993 (American Society for Testing and Materials) Standard Test Method for Determining Bacterial Retention of Membrane Filters utilized for Liquid Filtration similar to HIMA document but more detailed in
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