株洲製藥廠高效過（guò）濾器

關於高效過濾器（qì）的更換周（zhōu）期方麵的問題，很（hěn）多潔淨室用戶（hù）都很關心，畢（bì）竟高效過濾器（qì）決定著潔淨（jìng）室的潔淨度能否達（dá）到標準，就在前方91小视频也整理過相關方麵的問題：高效過濾器的更（gèng）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（xiào）過濾器（HEPA）用於生產空間空氣的處理和過濾的終端過濾（lǜ）器。無菌生產要求強製使用高效過濾器（qì），而固（gù）體和半固體劑型（xíng）的生產有（yǒu）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（chǎng）高效過濾器一般多（duō）久更（gèng）換？

我（wǒ）們經常看到在公（gōng）司內部文件中，要求（qiú）每年更換過濾器，而不管檢測（cè）結果如何。這是否（fǒu）合理？在相關的GMP指南中並沒有高效過濾器可以使用期限的具（jù）體（tǐ）數（shù）值。根據GMP的要求（qiú），過濾器不得有（yǒu）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（lái）說這（zhè）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（yuè）進行（háng）泄漏測（cè）試，C/D級則為12個月。FDA無（wú）菌指南要求進（jìn）行定期檢查。附錄1的要求在這（zhè）裏也適用。泄漏是可以修補的，但修補的麵積不能超過單個過濾器麵積的（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，廣州靈潔淨化高效（xiào）過濾器並不隻有完整性一件事情。過濾器（層）的負載以及上下（xià）遊壓差也很重要。如果過濾器上下遊壓（yā）差升高，則送排風係統的能量（liàng）需求會增加，這樣才能維持必須的換氣次數。這樣的過濾器上下遊壓差可能會增加通（tōng）風係（xì）統的性（xìng）能限製。為了保護高效過濾器，就要使用前端過濾器---通（tōng）常是像F7和F9過濾器（EN779）這樣的精細過濾器。這（zhè）些（xiē）過濾器必須定（dìng）期更換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，91小视频可以說最長使用期限直接取決於上下遊壓差。隻有在上下（xià）遊壓差達到一定數值影響到通風係統的性能，或者是能量需求超過過濾器更換成本時，過濾器更換（huàn）才有意（yì）義。但是，過（guò）濾器必須（xū）能通過泄漏測試（如上所述（shù））。事實上，很多公司並不會使用一個過濾器超（chāo）過8年。正如前述，並沒有法規規定這樣的值，這都隻是根據經驗得來的。

靈潔高效過濾器更換問題

谘詢內容：老師您好，小（xiǎo）容（róng）量注射劑車間空調係統的高效過濾器必須定（dìng）期更換嗎？如不定期更（gèng）換（huàn），隻在空調驗證時更換風量不（bú）合格房（fáng）間高效和撿漏不合（hé）格高（gāo）效可以嗎？

CFDA審核查驗中心回複：你好，更換高效（xiào）過濾器根據空調驗證（zhèng）參考：時（shí）風量和撿漏是必須的，但同時也應製定（dìng）出具（jù）體高（gāo）效過濾器最長使用周期，故還是（shì）應該有定（dìng）期的概念。同時必須定期進行過濾器完整性測試。

製（zhì）藥廠高（gāo）效過濾器（qì）一般多久更換？

潔（jié）淨區A級高效過濾器（qì）檢漏

谘詢內容：潔（jié）淨區A級高效過濾器檢漏是否可以使用 塵埃粒（lì）子（zǐ）計（jì）數器 掃描檢漏，如果可以，那麽判斷無泄漏的標準是多少。

CFDA審核查驗中心（xīn）回複：靈潔高效（xiào）過濾器檢漏一般在非關鍵區（qū）域可以使用塵（chén）埃粒子計數器，但A級潔淨區高效過濾器不推薦使用塵埃粒子計數器掃（sǎo）描檢漏