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USP 41版通则 <1229.4>Sterilizing Filtration of Liquids 液体除菌过滤
故障分析
完整新测试失败原因可能是滤芯损坏,套筒密封圈不严密,滤芯浸润不全,滤芯不完整。也可能是使用了孔径错误的滤芯,完整性测试仪设置不当,校对不当。
重新评估测试设置,参数设定,浸润溶液,浸润程序;检查系统有无泄漏,温度是否恒定,完整性测试仪是否设置无误,校对无误。
经上述办法仍无法确定失败的原因,可以加大冲洗液数量延长冲洗时间,加大压差,重新进行完整性试验。也可以使用低张力的溶液浸润(例如 70%异丙醇)。如果问题仍未解决,将检测仪送回制造厂检修。
Troubleshouting
Failure of a filter to pass an integrity test may mean that the filter is damaged, is improperly sealed in the housing, is incompletely
wetted, or is nonintegral. It also could mean that the filter is incorrectly labeled (e. g, has the wrong pore size)or that
the integrity test apparatus has been improperly set up or calibrated.
The cause of an integrity test failure can be determined by evaluating the test setup, test parameters, wetting fluid, and wetting
procedure; ensuring that the system is leak-free and the temperature is constant; and ensuring that the test equipment has been
properly calibrated.
If the cause of the failure cannot be determined, analysts can rewet the filter and repeat the integrity test, increasing flush time, flush
volume, and pressure differential. It may be beneficial to use a lower surface tension reference fluid (e. g. 70% isopropyl alcohol). If
the filter fails the integrity test using the reference fluid, it should be considered nonintegral. In addition, the filter can be returned to the
manufacturer for a full analysis to further elucidate the cause of the integrity test failure.
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