中山制药厂高效过滤器

关于高效过滤器的更换周期方面的问题，很多洁净室用（yòng）户都很关心，毕竟高效过滤器决定着洁净室的洁净度能否达到标准，就在前方我们也整理过相关方面的问题：高效（xiào）过（guò）滤（lǜ）器的更换标准

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（háng）业，高效过滤器（HEPA）用（yòng）于生产空间空气的处理和（hé）过滤的终端过（guò）滤器。无菌生产要求强（qiáng）制使用高效过滤器，而固体和半固体剂型的生产有时也会使（shǐ）用（yòng）。H13至H14（DIN1822）是高效过滤器的两种，后（hòu）者截留率（lǜ）为99.995%。但多久必须更（gèng）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 参考：（www.ljinghua.com）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.

制药厂高效过滤器一般多久更换？

我们经常看到在（zài）公司内部文件中，要求每年更换过滤器，而不管检测结果如何。这是否合理？在相关的GMP指南中并没有高（gāo）效（xiào）过滤器（qì）可以使用期限的具体数值。根据GMP的要求，过滤器不得（dé）有泄漏，这需（xū）要通过确认（rèn）和定期执行ISO14644-3中的泄漏测试，无（wú）菌车间来说这是必须的。根据（jù）附录（lù）1（PIC/S PI032-2）的技术（shù）诠（quán）释，A/B级每6个月进行泄漏测试，C/D级则为12个月。FDA无菌指南要求进行定期检查。附录1的要求在这（zhè）里也适用。泄漏是可以（yǐ）修补的，但修补（bǔ）的面积不能（néng）超过单（dān）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，广州灵（líng）洁净化高效过滤器并不只有完整性（xìng）一件事情。过滤器（层）的负载以及上（shàng）下游压差也很重要。如果过滤器上下游压差升高，则送排风系统的能（néng）量需求会增加，这（zhè）样才能维持必须的换气（qì）次数。这样的过滤器上下游压差可能会增加通风系统的（de）性能限制。为了保护高效过（guò）滤器，就要（yào）使用（yòng）前端过滤器---通常是（shì）像F7和F9过滤器（EN779）这样的精细过滤器。这（zhè）些过（guò）滤器（qì）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（shuō）最长使（shǐ）用期限直接取（qǔ）决于上下游压差。只有在上（shàng）下游压差达到一定数值影响到通风系统的性能，或者是能量需求超过过滤器（qì）更换成本（běn）时，过（guò）滤器更换才有意义（yì）。但是（shì），过滤（lǜ）器必须（xū）能通（tōng）过泄（xiè）漏测试（如上所述）。事实上，很多公司并（bìng）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（dōu）只是根据经验得来的。

灵洁高效过滤器更换问题

咨询内容：老师您（nín）好，小（xiǎo）容量注射剂（jì）车间空调（diào）系统的（de）高（gāo）效过滤器必须定期更换吗？如不定期更换，只在空调验证时更换风量不合格房间高效和捡漏（lòu）不合格高效（xiào）可以吗？

CFDA审核查验中（zhōng）心回复：你好，更换高效过滤器根据空调验证参考：时风量和捡漏（lòu）是必须的，但同时也应制定出具体高效过滤（lǜ）器（qì）最长使用周期（qī），故（gù）还是应该有定（dìng）期的概念。同时必须定期进行过滤器完整性测（cè）试。

制药厂高（gāo）效过滤器一（yī）般（bān）多久更换（huàn）？

洁净区（qū）A级高效过滤器检漏

咨询内容：洁净区A级高效过滤器检（jiǎn）漏是否可以使用 尘埃粒子计数器（qì） 扫描检漏，如果可以，那么（me）判断（duàn）无泄漏的标（biāo）准是多少。

CFDA审核查验（yàn）中心回复：灵洁高效过滤器检漏一般在非关键区域可以使用尘埃粒子计数器，但A级洁净区高效过滤器不推荐使用尘埃粒子计数器扫描（miáo）检漏