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高效过滤器多久必须更换?  

2017-06-28 19:23:27|  分类: 工作【GMP知识】 |  标签: |举报 |字号 订阅

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How often do HEPA Filters have to be changed?

高效过滤器多久必须更换?

In the pharmaceutical industry, HEPA filters are used as terminal filters for the processing or filtration of air in production spaces. They are mandatory in sterile production, although they are sometimes also used in the manufacture of solid or semisolid dosage forms. Amongst the HEPA or high-efficiency particulate air filters are Filter Classes H13 to H14 (DIN 1822), the latter with a retention rate of 99.995%. But how often do they need to be changed?

在制药行业,高效过滤器用于生产空间处理和过滤空气终端过滤器。高效过滤器在无菌生产中是必须使用的,当然有时也会用于固体和半固体剂型的生产。H13H14DIN1822)是高效过滤器的两种,后者截留率为99.995%。但多久必须更换一次呢?

One can frequently find internal company guidelines according to which the filters should be changed annually, regardless of monitoring results. Is that sensible? An exact number, meaning the maximum duration of use for HEPA filters in months, cannot be found in the relevant GMP guidelines. According to GMP, the filter has to be free of leaks. This is verified by qualification and regularly performed leak tests as per ISO 14644-3, which are mandatory for sterile facilities. According to the technical interpretation of the Annex 1 (PIC/S PI 032-2), leak tests are to be performed every six months in A/B zones and every twelve months in C/D zones. The FDA Aseptic Guide demands a regular inspection. The requirements of Annex 1 can be applied here as well. Leaks may be repaired; those repaired areas may only take up 0.5% of the filter surface per filter.

我们经常会看到在公司内部文件中,要求每年更换过滤器,而不管监测结果如何。这合理么?在相关的GMP指南中其实并没有高效过滤器可以使用时长的具体数字。根据GMP的要求,过滤器必须无泄漏,通过确认和定期执行ISO14644-3泄漏测试就能进行核对,无菌车间来说这是必须的。根据附录1PIC/S PI032-2)的技术诠释,A/B区每6全月要进行泄漏测试,C/D级区则为12个月。FDA无菌指南要求进行定期检查。附录1的要求在这里也可以应用。泄漏是可以修补的,但修补的面积不能超过单个过滤器面积的0.5%

However, not only the integrity of the HEPA filter is relevant. The load of the filter (layer) and thus the pressure drop at the filter is also important. If the pressure drop at the filter rises, the energy demand of the ventilation system increases to maintain the necessary air change rates. This pressure drop at the filter can increase to the performance limits of the ventilation system. To protect the HEPA filters, preliminary filters are used - usually fine particulate air filters like F7 und F9 filters (EN779). Those have to be replaced regularly and protect the HEPA filters from clogging.

当然,高效过滤器并不只有完整性一件事情。过滤器(层)的负载以及压力降也很重要。如果过滤器压降升高,则送排风系统的能量需求会增加,用以维持必须的换气率。这样的过滤器压降可能会增加通风系统的性能限制。为了保护高效过滤器,就要使用前端过滤器---通常是像F7F9过滤器(EN779)这样的精细过滤器。这些过滤器必须定期更换以保护高效过滤器避免堵塞。

From a practical viewpoint, one could say that the maximum duration of use depends directly on the pressure drop. Changing the filters only makes sense if the pressure drop gets too high for the performance of the ventilation system or if the cost of energy demand lies above the cost of a filter change. The filters do have to pass the leak tests (see above), of course. In practice, several companies do not use a filter for more than eight years. As mentioned before, though, this is not a legally binding value, but merely based on experience.

从实践角度来看,我们可以说最长使用时长直接取决于压降。只有在压降达到一定高值影响到通风系统的性能,或者是能量需求超过过滤器更换成本时,过滤器更换才有意义。当然,过滤器必须能通过泄漏测试(见上)。尤其是,几个公司并不会使用一个过滤器超过8年。正如前述,并没有法规规定这样的值,这都只是根据经验得来的。

流体在管中流动时由于能量损失而引起的压力降低。这种能量损失是由流体流动时克服内摩擦力和克服湍流时流体质点间相互碰撞并交换动量而引起的,表现在流体流动的前后处产生压力差,即压降

压降的大小随着管内流速变化而变化。

在空调系统运行时管内光滑程度,连接方式是否会缩孔截流也会影响压降。

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