湖南製藥廠（chǎng）高效過（guò）濾器

關於高效過濾器的更換周期方麵的問題（tí），很多潔淨室用（yòng）戶都（dōu）很（hěn）關心（xīn），畢竟（jìng）高效過濾器決定著潔淨室的潔（jié）淨度（dù）能否達到標準，就在前方草莓秋葵菠萝蜜黄瓜榴莲视频也整理過相關方（fāng）麵的（de）問題：高效過濾（lǜ）器的更（gèng）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，高效（xiào）過濾（lǜ）器（HEPA）用於生產空間空（kōng）氣的處理和過濾的終端過濾器。無菌生產要求強製使（shǐ）用高效過濾器（qì），而固體和半固體劑型（xíng）的（de）生產（chǎn）有時也會使用。H13至H14（DIN1822）是高效過濾器的兩種，後者（zhě）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（lǜ）器一般多久更換？

草莓秋葵菠萝蜜黄瓜榴莲视频（men）經常看到（dào）在公司內部文件中，要求每年更換過濾器，而不管檢測結果（guǒ）如何。這是否（fǒu）合理？在相關的（de）GMP指南中並（bìng）沒有高效過濾器可以使用期限的（de）具體（tǐ）數值。根（gēn）據GMP的要求，過（guò）濾（lǜ）器不得有泄漏，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）的技術詮（quán）釋，A/B級（jí）每6個月進行泄漏測試，C/D級則為（wéi）12個月（yuè）。FDA無菌指南要（yào）求進行定期檢（jiǎn）查。附錄（lù）1的要求在這裏（lǐ）也適用（yòng）。泄（xiè）漏是可以修補的，但修補的麵積（jī）不能（néng）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，廣州靈潔淨化高效過濾器並不隻有完整性一件事情（qíng）。過濾（lǜ）器（層）的負載以及上下遊壓差也很重要。如果（guǒ）過濾器（qì）上下遊壓差升高，則送排風係統的能量需求會增加，這樣才能維持必須的換（huàn）氣次數。這樣的過濾器上下遊壓差可能會增加（jiā）通風係統（tǒng）的性能限製。為了保護高效過濾器，就（jiù）要使用前端過濾器---通常（cháng）是像F7和（hé）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）以保護高效過濾器避免堵塞

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，草莓秋葵菠萝蜜黄瓜榴莲视频可以說最長使用期（qī）限直接取決（jué）於上下遊壓差。隻有在上下遊壓差達到一定數值影響到通風係統的性能，或者是能量需（xū）求超過過（guò）濾器更換（huàn）成本時，過濾器更換才有意義。但（dàn）是，過濾器必須能通過泄漏測（cè）試（如上所述）。事實上，很（hěn）多公司並不會使用一個（gè）過濾器超過8年。正如前述，並沒有法規規定這樣的值，這（zhè）都隻是根據經驗（yàn）得（dé）來的。

靈潔高效過濾器更換問題

谘（zī）詢內容：老師（shī）您好，小容量注射劑車間空調係統的高效過（guò）濾（lǜ）器必須定期更換嗎？如不定期更換，隻在空調（diào）驗（yàn）證時更換風量不合格房間高效和撿漏不合（hé）格高效可以嗎？

CFDA審核查驗中心回複：你好，更換高效過（guò）濾器根據空調驗證參考：時風量和撿漏是必（bì）須的，但同時也應製定出具體高效過濾器最（zuì）長使用周（zhōu）期（qī），故還是應該（gāi）有定（dìng）期的（de）概念（niàn）。同時必須定期進行過濾器完整性測試。

製藥廠高效過濾（lǜ）器一般多久更換？

潔淨區A級高效過濾器（qì）檢漏

谘詢內（nèi）容：潔淨（jìng）區A級高效過濾（lǜ）器檢漏是（shì）否可（kě）以使用 塵埃粒子計數器 掃描（miáo）檢漏，如（rú）果可以，那麽判斷無泄漏的標準是多（duō）少。

CFDA審（shěn）核查驗中心回複：靈（líng）潔高效過濾（lǜ）器檢漏一（yī）般在非關鍵區域可以使用塵埃粒子計數器，但A級潔淨區高（gāo）效過濾器不推薦使用塵埃粒子計數器掃（sǎo）描檢漏