本帖最后由 beiwei5du 于 2017-1-4 19:18 编辑
这个是节选至国外的GMP论坛的回答!其实我想说的“最终的依据肯定是检漏”这句话并不是对的,因为有时能达到leak test的要求,但是风量/换气次数达不到要求,也是会有风险的。@江苏新征鸿净化 我个人觉得下文的考虑点还是相对比较充分的,仅供参考! Hello liliadis, I am not aware of guideline about HEPA replacement frequency.
There are many installations and machines with HEPAs, running under different operational (one or more shifts, continuous operation) and environmental conditions, which affect filter lifetime.
You should consider the results of HEPA regular tests, supplier recommendations and also own experience. Or experience of the other users with the same/similar HEPA installation and conditions. HEPA filters should be replaced always when:
1. the recommended air velocity under filter cannot be readjusted any more. This can indicate that HEPA is clogged.
2. the filter resistance reaches HEPA supplier's max. admissible pressure. This indicates that HEPA is clogged. But in practice HEPAs used to be replaced sooner due to energy savings.
3. the pressure drop reaches approx.-10% of the initial pressure. This indicates leak.
4. the leak test not passed
5. replacement is necessary according to the replacement intervals (recommended by supplier or based on own experience) . FAQ from the one HEPA supplier is attached. Cheers,
Adrian 最后再加上其他的网友回答的routine test监测,可能就比较完善了! |