汕（shàn）尾製藥廠高效過濾器

關於高效過濾器的更換（huàn）周期方麵的問題，很多（duō）潔淨室用戶都很關心，畢竟高（gāo）效過（guò）濾器決定著潔（jié）淨室的潔淨度能否達到標準，就在前方我（wǒ）們也整理過相關方麵的問題：高效過濾器的更換標準

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?

在製（zhì）藥行業（yè），高效過濾器（HEPA）用於生產空間（jiān）空氣（qì）的處理和（hé）過濾的終端過濾器。無菌生產要求強製使用高效過濾器，而固體和（hé）半固體（tǐ）劑型的生產有時也會使用。H13至H14（DIN1822）是高效過濾器的兩種，後者截留率為99.995%。但多久（jiǔ）必（bì）須更換一（yī）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 參考：（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.

製藥廠（chǎng）高效過濾器一般多久更換？

我（wǒ）們經常看（kàn）到（dào）在公司內部文件中，要求每年更換過濾器，而不管（guǎn）檢測（cè）結（jié）果如何。這是否合理？在相關的GMP指南（nán）中並沒（méi）有高（gāo）效過濾器可以使用（yòng）期限的具體數值。根據GMP的要求，過濾器不得有泄漏，這需要通過確認和定期執行ISO14644-3中（zhōng）的泄漏測試，無菌車間（jiān）來說這是必須的。根據附錄（lù）1（PIC/S PI032-2）的技術詮釋，A/B級每6個月進行泄漏測試，C/D級則為12個月。FDA無菌指南要求進（jìn）行定期檢查。附錄1的要求在這裏也適用。泄漏是（shì）可以修補的，但修補的麵積不能超過單個過濾器麵積（jī）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.

當然，廣州靈潔淨化高效過濾器並不隻有完整性一件事情。過濾器（層）的負載以及上（shàng）下（xià）遊壓差也很重要。如果過濾器上下遊壓差（chà）升（shēng）高，則（zé）送（sòng）排風係統的能量需（xū）求會增加，這樣才能維持必須的換氣次數。這（zhè）樣的過濾器上下遊壓差（chà）可能會增加通風係統的性能限製。為了保護（hù）高效過濾器，就（jiù）要使用前端過濾器（qì）---通常是像F7和F9過濾器（EN779）這樣的精細過（guò）濾器。這些過濾器必須定期更換以保護高效過濾器避免（miǎn）堵塞（sāi）

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.

從實踐角度來看，草莓秋葵菠萝蜜黄瓜榴莲视频可以說（shuō）最長使用期（qī）限直（zhí）接取決於上下遊壓差。隻有在上（shàng）下（xià）遊壓差達到一定數值影響到通風係統的性能（néng），或者是能（néng）量（liàng）需求（qiú）超過過（guò）濾器更換成本（běn）時，過濾器更換（huàn）才有意義。但是，過濾器必（bì）須能通過（guò）泄漏測試（如（rú）上所（suǒ）述）。事實上（shàng），很（hěn）多（duō）公司並不會使用一（yī）個過濾器超過8年。正如前述，並沒有法規規定（dìng）這樣的值，這都隻是根據經驗得來的。

靈潔高效過濾器更換問題

谘詢內容：老師您好，小容量注射（shè）劑車間空調係統（tǒng）的高效過濾器必須定期更換嗎？如不（bú）定期更換，隻在空調驗證時更換風（fēng）量不合格房間高效和撿漏不合格高效可以嗎？

CFDA審核查驗中心回複：你好，更換高效過濾器根據空調驗（yàn）證參考：時風量和撿漏是必須的，但同時也應製定出具體高效過濾器（qì）最長使用周期，故還是應該有定期的概（gài）念（niàn）。同時必須定期進（jìn）行過濾（lǜ）器完（wán）整性測試。

製藥廠高效過濾器一般（bān）多久更（gèng）換？

潔淨區（qū）A級（jí）高效過濾器檢漏

谘詢（xún）內容：潔淨區A級（jí）高效過濾器（qì）檢漏是否可以使用 塵埃粒子計數（shù）器 掃描檢漏，如果可以，那麽（me）判（pàn）斷無泄漏的（de）標準是多少（shǎo）。

CFDA審（shěn）核查驗中心回複：靈潔高效過濾器檢漏一般在非（fēi）關（guān）鍵區域（yù）可以使用塵埃粒子計（jì）數器，但A級潔淨區高（gāo）效過濾器不推薦使（shǐ）用（yòng）塵（chén）埃粒子計數（shù）器掃描檢漏