張家（jiā）界製藥（yào）廠高效過（guò）濾器

關於高效過濾器的更換周期方麵（miàn）的問題，很多潔淨室用戶都很關心，畢竟高效（xiào）過濾器決（jué）定著潔淨室的潔淨度（dù）能否達到標準，就在前方我（wǒ）們也整理過相關方麵的（de）問題：高（gāo）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?

在製藥行業，高（gāo）效過濾器（qì）（HEPA）用於生（shēng）產空間空氣的處理和（hé）過（guò）濾（lǜ）的終端過濾器。無菌生（shēng）產要求強製使用高（gāo）效過濾器，而固（gù）體和半固（gù）體劑型的生產有（yǒu）時也會使（shǐ）用。H13至H14（DIN1822）是高效過濾（lǜ）器的兩種，後者截留率為99.995%。但多久必須更換一（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.

製藥廠高效過（guò）濾器一般多久更換？

91小视频經常看到在公司內部文（wén）件（jiàn）中，要求每年更換過濾器，而不管檢測結（jié）果如何（hé）。這是否合理？在相關（guān）的GMP指南中並沒有高效（xiào）過（guò）濾器可以使用期限的具體數值。根據GMP的要求，過濾（lǜ）器不得有泄漏（lòu），這需（xū）要通過確認和定期執行ISO14644-3中的泄漏測試，無菌車間來說（shuō）這是必須的。根據附錄1（PIC/S PI032-2）的技術詮釋，A/B級每6個月進行泄漏測試，C/D級則為（wéi）12個月。FDA無菌指南（nán）要求進行定期檢查。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（de）麵積不能超過單個過濾器麵積（jī）的（de）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（rán），廣（guǎng）州靈潔淨化高效過濾器並不隻有完整性一件事情。過（guò）濾器（層）的（de）負載以及上下遊壓差也很重要。如果過濾器上（shàng）下遊壓（yā）差升高，則送排風係統的能量需求會增加，這樣才（cái）能維持必須的換氣次（cì）數。這樣的過濾器（qì）上（shàng）下遊壓差可能會增加通風係統的性能限（xiàn）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（hé）F9過濾器（EN779）這樣的（de）精細過濾器。這些過濾器（qì）必（bì）須定期更換以保護高（gāo）效過濾器避免堵塞

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.

從實踐角度來看，91小视频可以說最長使用期限直接取（qǔ）決於上下遊壓差。隻有在（zài）上下遊（yóu）壓（yā）差達到一定數值（zhí）影響到通風係（xì）統的性能，或者是能（néng）量需求超過過濾器更換成本時，過（guò）濾器更換才有意義。但是，過濾器必須能通過泄漏測試（如上所述（shù））。事（shì）實上，很多公司並不會使（shǐ）用一個過濾器超過8年。正如（rú）前述，並沒有法規規定這樣的值，這都隻是根據經驗得（dé）來的。

靈潔（jié）高效（xiào）過濾器（qì）更換問題

谘詢內容：老師您好，小容量（liàng）注射劑車間空調（diào）係統的高效過濾器必須定（dìng）期更（gèng）換嗎？如不定（dìng）期更換（huàn），隻在空調驗證時更換風量不合格房間高效和撿漏不合格高效可以嗎？

CFDA審（shěn）核查驗中心回複（fù）：你好，更換（huàn）高效過濾器根據空調（diào）驗證參考：時風量和撿漏是必須的，但同時也應製定出具體高效過濾（lǜ）器最（zuì）長使用周期，故還是應該有（yǒu）定期的概念。同時（shí）必須定期進行過濾器完（wán）整性測試。

製藥廠高效過濾器（qì）一（yī）般多久更換（huàn）？

潔淨區A級高效過濾器檢漏（lòu）

谘詢（xún）內容：潔淨區A級高效過濾器檢（jiǎn）漏是否可以使用 塵（chén）埃粒子計數器 掃描檢（jiǎn）漏，如果可以，那麽判斷無泄漏的標準是多少。

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