Aranha H, Meeker J
Pall Corporation, Port Washington, New York, USA.
PDA J Pharm Sci Technol. 1995 Mar-Apr;49(2):67-70.
Regulatory guidelines for aseptic manufacture of pharmaceuticals recommend validation of sterilizing filters by bacterial challenge under "worst case" conditions. The microbial retention characteristics of a sterilizing grade, 0.2-microns-rated Nylon 66 membrane filter were evaluated for filtration of high viscosity fluids. Glycerol (80%) was used as the carrier fluid and Pseudomonas diminuta ATCC 19146 as the challenge organism. Testing was carried out at a constant differential pressure of 60 psig over a six-hour test period. Test runs were undertaken at three different temperature conditions (25 +/- 5 degrees C, 42 +/- 1 degree C, and 50 +/- 1 degree C). Under the test conditions, the Nylon 66 membranes provided total retention of P. diminuta. The results demonstrated that a high pressure differential challenge using a high viscosity fluid over a six-hour test period at ambient and elevated temperatures did not alter the retention characteristics of the membrane filter.
药品无菌生产的监管指南建议在“最差情况”条件下通过细菌挑战试验对除菌过滤器进行验证。对一款除菌级、额定孔径为0.2微米的尼龙66膜过滤器在过滤高粘度流体时的微生物截留特性进行了评估。使用甘油（80%）作为载液，以缺陷假单胞菌ATCC 19146作为挑战微生物。在60 psig的恒定压差下进行为期6小时的测试。在三种不同温度条件（25±5℃、42±1℃和50±1℃）下进行测试运行。在测试条件下，尼龙66膜可完全截留缺陷假单胞菌。结果表明，在环境温度和升高的温度下，使用高粘度流体在6小时测试期内进行高压差挑战不会改变膜过滤器的截留特性。
