四川製藥廠高效（xiào）過濾（lǜ）器

關於高效過濾器（qì）的更換周期方（fāng）麵（miàn）的問題，很多潔淨室用戶都很關心，畢竟高效過（guò）濾器決定著潔淨室的潔（jié）淨度能否達到標準，就在（zài）前方嫩草影院也整理過相關方麵的問題：高效（xiào）過濾器的更換標準（zhǔn）

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，高效過（guò）濾器（HEPA）用於生產（chǎn）空間空氣的處理和（hé）過濾的終端（duān）過濾器。無菌（jun1）生產要求強製使用高（gāo）效過濾器，而（ér）固體和半（bàn）固（gù）體劑型的生產有時也會使用（yòng）。H13至（zhì）H14（DIN1822）是高（gāo）效過濾器的兩種，後者截（jié）留率為99.995%。但多久（jiǔ）必須（xū）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更換？

嫩草影院（men）經（jīng）常看到在公司內（nèi）部（bù）文件中，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（de）GMP指南中並沒有高（gāo）效過濾器可以使用期限的具體數值。根據GMP的要求，過濾器不得有泄漏，這需（xū）要通過確認和定期執行ISO14644-3中的（de）泄漏測試，無菌車間來說這是必須的。根據（jù）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12個（gè）月（yuè）。FDA無菌指南要求進（jìn）行定期（qī）檢查。附錄1的要求在這裏也適（shì）用。泄漏是可（kě）以修補的，但修補的麵積不能超過單個過濾器麵積的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，廣州靈潔淨化高效過濾器並不（bú）隻有完整性一件事情。過（guò）濾器（層）的負載以及上下遊壓差也很重要。如（rú）果過濾器上下（xià）遊壓差升高，則送排風係（xì）統的能量需（xū）求（qiú）會增加，這樣才（cái）能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（zēng）加通風係統的性能限製。為了保護高效過濾器，就要使用前端過濾器（qì）---通常是像F7和F9過濾器（qì）（EN779）這（zhè）樣（yàng）的精（jīng）細過（guò）濾器。這些過濾器（qì）必須定（dìng）期更換以保護高效過濾器避免（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，我（wǒ）們可以說最（zuì）長使用期限直接取決於上下遊（yóu）壓差。隻有（yǒu）在上下遊壓差達（dá）到一定（dìng）數值影響到通風係統的性能，或者是能量需求超過過濾器更換成本時，過（guò）濾（lǜ）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）。事實上，很多公司並不會使用一個過（guò）濾器超過8年。正如（rú）前述（shù），並（bìng）沒有法規規（guī）定這樣的（de）值，這都隻是根據經驗得來的（de）。

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調係統（tǒng）的高效過濾器必須定期（qī）更換嗎？如不定期更換，隻在空調驗證時（shí）更（gèng）換風量不合格房間高效和撿漏不合格高（gāo）效（xiào）可以嗎？

CFDA審核查驗中（zhōng）心回複：你好（hǎo），更換高效過濾器根據空調驗證參考：時風量和撿漏是必須的，但（dàn）同時也應（yīng）製定（dìng）出具體高效過（guò）濾器最長使用周期，故還是應該有定期的概念。同（tóng）時必須定期進行過濾器（qì）完（wán）整性測試。

製藥廠高效過濾器一般多久更換？

潔（jié）淨（jìng）區A級高效過（guò）濾器檢漏

谘詢內容：潔淨區A級高（gāo）效過濾（lǜ）器檢漏（lòu）是（shì）否可以使用 塵埃粒子計數器 掃描檢漏，如果可以，那麽判斷（duàn）無泄漏的標準是多（duō）少。

CFDA審核查驗中心回複：靈潔高效過濾器檢漏一般在非關鍵區域可以使用塵埃粒子計數（shù）器（qì），但（dàn）A級潔淨區高效過濾器不推薦使用塵埃粒子計數器掃描檢（jiǎn）漏（lòu）