長春製（zhì）藥廠高（gāo）效過濾（lǜ）器

關（guān）於高效過濾器（qì）的更換（huàn）周（zhōu）期方麵（miàn）的問題，很多潔淨室用戶都（dōu）很關心，畢竟高效過濾器決定著潔淨室的潔（jié）淨度能否達到標準，就在前方91小视频也整理過相關方麵的問題：高效（xiào）過（guò）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?

在製藥行業，高效過濾器（HEPA）用於生產空間空氣的處（chù）理和過濾的終端過（guò）濾器。無（wú）菌生（shēng）產要求強製使（shǐ）用（yòng）高效過（guò）濾（lǜ）器（qì），而固體和半固體劑型的生產有時也會使用。H13至H14（DIN1822）是（shì）高效過濾器的兩種，後者截留率為99.995%。但多久必須更換一次呢？

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（yào）廠高效過濾器一般（bān）多久更換？

91小视频經常看到在公司（sī）內部文件中，要求每（měi）年更換過濾器，而不管（guǎn）檢（jiǎn）測結果如何。這是否合（hé）理？在相關的GMP指南中並（bìng）沒有高效過濾器可以使用期（qī）限的具體數值。根據（jù）GMP的要求（qiú），過濾（lǜ）器不得（dé）有泄漏，這需（xū）要通過確認和定期執行ISO14644-3中的泄漏測（cè）試，無菌車間來說（shuō）這（zhè）是必須（xū）的。根據附錄1（PIC/S PI032-2）的技術詮釋，A/B級每6個月進行泄漏測（cè）試（shì），C/D級則為（wéi）12個月。FDA無菌指南要求進行定期檢查。附錄（lù）1的要求在這裏也適用。泄漏是可（kě）以修補的，但修補的麵（miàn）積不能超過單個（gè）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，廣州靈潔淨化高效過濾器並不隻有完整性（xìng）一件事情。過濾（lǜ）器（層（céng））的負載以及上下遊壓差也很重要。如果過濾（lǜ）器上下遊壓差（chà）升（shēng）高，則送排風係統的能量需求會增（zēng）加，這樣才能維持必須（xū）的換氣次數。這樣的過濾器上下遊壓差（chà）可能會增加通風係統的（de）性（xìng）能限製。為了保護高（gāo）效過濾器，就要使用前端過濾器---通常是像F7和F9過濾器（EN779）這樣的精細過濾器。這些過濾器必須定期更換（huàn）以保護（hù）高效過濾器避免（miǎn）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，91小视频可以說最長使用期限（xiàn）直接取決於上下遊壓差。隻有在上（shàng）下遊壓差達到（dào）一定數值（zhí）影響到通風係統的（de）性能，或者是（shì）能量需（xū）求超（chāo）過過濾器更換成本時（shí），過濾器更換才（cái）有意義。但是，過濾器必（bì）須能（néng）通過泄漏（lòu）測試（如（rú）上所述）。事實上，很多公司並不會使用一個過濾器超過8年。正如前述，並（bìng）沒有法規規定這樣的值，這都隻（zhī）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，小容量注射劑車間空（kōng）調係統的高效過濾器必須定（dìng）期更換嗎？如不定期更換，隻在空（kōng）調驗證時更換風量（liàng）不合格房間高效和撿漏不合格高效可以（yǐ）嗎（ma）？

CFDA審核查驗中心（xīn）回複（fù）：你好，更換高效過濾器根據空調驗證（zhèng）參考：時風量和撿漏是必須的，但同時（shí）也應製定出具體高效過濾器最長使用周期，故還是應該有定期的（de）概念（niàn）。同時必（bì）須（xū）定期進行過濾器完整性測試（shì）。

製（zhì）藥廠高效過濾器一般多久更換？

潔淨區A級高效（xiào）過濾器檢漏

谘詢內容（róng）：潔淨區A級高效過濾器檢漏是否可以使用 塵埃粒子計數器 掃描（miáo）檢漏，如果可以，那麽判（pàn）斷無泄漏的標準是多少。

CFDA審（shěn）核查驗中心回複：靈潔高（gāo）效過濾器檢漏一般在非（fēi）關鍵區域（yù）可以使用塵埃粒子（zǐ）計數器，但A級潔淨（jìng）區高效過濾器不推（tuī）薦使用塵埃粒子計數器掃描檢（jiǎn）漏