延安製藥廠高（gāo）效過濾器

關於（yú）高效過濾器的（de）更換（huàn）周期方麵的問題（tí），很多潔淨室用（yòng）戶都很關（guān）心，畢（bì）竟高效過（guò）濾（lǜ）器決定著潔淨室的潔淨（jìng）度能否達到標準，就在前方嫩草影院也整理過相關方麵的（de）問（wèn）題：高效過濾器的更換標（biāo）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?

在製藥行業，高效過濾器（HEPA）用於生產空間空氣的處（chù）理和過（guò）濾的終端過（guò）濾器。無菌生產要求（qiú）強製使用高效過濾器，而固體和半固體劑型的生產（chǎn）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（duō）久必須更換一次呢？

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 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.

製藥廠高效過濾器一般多久（jiǔ）更換？

嫩草影院經常看到在公司內部文（wén）件中，要求每年更換過濾器，而不管檢測結果如何。這是否合理？在相關的GMP指南中並沒（méi）有（yǒu）高效過濾器可以使用（yòng）期限的具體數值。根據GMP的要求，過濾器（qì）不得有泄漏，這需要通過確認和定期執行ISO14644-3中的泄漏測試，無菌車間來說這是必須的。根據附錄1（PIC/S PI032-2）的（de）技術詮（quán）釋，A/B級每6個月（yuè）進行泄（xiè）漏測試，C/D級則（zé）為12個月。FDA無菌指南要求進行定期檢查（chá）。附錄1的要求在這裏也適（shì）用。泄漏是可以修補的，但修補的麵積不能超過（guò）單個過濾器麵積的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（líng）潔淨化高效過濾器並（bìng）不隻有完整性一件事（shì）情。過濾器（層）的負載（zǎi）以及上（shàng）下遊壓差也很重（chóng）要。如果過濾器上下遊壓差（chà）升（shēng）高，則送排風係統的能量需求會增加，這（zhè）樣才（cái）能（néng）維持必須的換氣次數。這樣的過濾器上（shàng）下遊壓差可能會增加通風（fēng）係統的性能限製。為了（le）保護高效過（guò）濾器，就要使用前端（duān）過濾器---通常（cháng）是像F7和F9過濾器（EN779）這樣的精細（xì）過濾器。這（zhè）些過濾（lǜ）器必（bì）須定（dìng）期更換以保護高效過濾器（qì）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.

從實踐角度來看（kàn），嫩草影院可以說最長使用期限直接取決於上下遊壓差（chà）。隻有在上下遊壓差達到一（yī）定數值影響到通風（fēng）係統的性（xìng）能，或者是（shì）能量（liàng）需求超（chāo）過過濾器更換成本時，過濾（lǜ）器更換才有意義。但是，過濾器（qì）必須能（néng）通過泄漏測試（shì）（如上（shàng）所述（shù））。事實上，很多公司並不會使用一（yī）個過濾器超（chāo）過8年。正如前（qián）述，並沒（méi）有法規規定這樣的值（zhí），這都隻是根據經驗得（dé）來的。

靈潔（jié）高效（xiào）過濾器更換問題

谘詢內容：老師您好，小容（róng）量注（zhù）射劑車間空調係（xì）統的高效過濾器（qì）必須定期更換（huàn）嗎（ma）？如不定期（qī）更換，隻在空調（diào）驗證時更換風量不合格房間（jiān）高效和撿漏不（bú）合格高效可以嗎？

CFDA審核查驗中心回複：你好，更換高（gāo）效過濾器根據空調驗證參考：時風量和（hé）撿漏是必須的，但同時（shí）也應製定出具體高效過濾器最長使用周期，故還（hái）是應該有定期的概念。同時必須定期進行過濾（lǜ）器完整性測試。

製藥廠高效過濾器一般多久更換？

潔淨區A級高效過濾器檢漏

谘詢內容：潔淨區A級高效過濾器檢（jiǎn）漏是否（fǒu）可以使用（yòng） 塵埃粒子計數器 掃描檢漏，如（rú）果可以，那麽判斷無泄漏（lòu）的標準是多少。

CFDA審核查驗中心回複（fù）：靈潔（jié）高（gāo）效過濾器檢漏一般在非關鍵（jiàn）區域可以使用塵埃粒子計數器，但A級潔淨區（qū）高效過濾器不推薦使用塵埃（āi）粒子計數器掃描檢漏