瀏陽製藥廠（chǎng）高效過濾器

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，畢竟高效過濾器決定著潔淨室的潔淨度能否達到標準，就在前方91小视频也整理過相關方麵的（de）問題：高效過濾器的更換（huàn）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（jiān）空氣的處（chù）理和過濾的終端過濾器。無菌生產要求強（qiáng）製使用高效過濾器（qì），而固體和半固體劑型的生產有時也會使用（yòng）。H13至H14（DIN1822）是高效過濾（lǜ）器的兩（liǎng）種，後者截留（liú）率為99.995%。但多久必須（xū）更（gèng）換一次呢（ne）？

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？

91小视频（men）經常看到在公司內部（bù）文件中，要求每年更換過濾器，而不管檢測結果如何。這（zhè）是否合理？在相關的GMP指南中並沒有高效（xiào）過濾器（qì）可（kě）以使用期限的（de）具體數值。根據GMP的要求，過（guò）濾器不得有泄漏（lòu），這需（xū）要通過確認和定期執行（háng）ISO14644-3中的（de）泄漏測試，無菌車間來說這是必須（xū）的（de）。根據附錄1（PIC/S PI032-2）的技術詮釋，A/B級每6個月進行泄（xiè）漏測試，C/D級則為12個月。FDA無菌指（zhǐ）南要求進行定期檢查。附錄1的要求在這裏也適（shì）用。泄漏是可以修補的，但修補的麵積不能超過（guò）單個過濾器（qì）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。過濾器（層（céng））的負載以及上（shàng）下遊壓差也（yě）很重要。如果過濾器上下遊（yóu）壓差升高，則送排風係統（tǒng）的能量需（xū）求會（huì）增加，這樣才能維持（chí）必須的換氣次數。這樣的過濾器上下（xià）遊壓差可能會增加通風係統的（de）性能限製。為了保護高效（xiào）過濾器，就要使用前端過（guò）濾器（qì）---通常是像F7和F9過濾器（EN779）這（zhè）樣的精細過濾器。這些過濾（lǜ）器必須定期更換以保護高效過濾（lǜ）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（jiǎo）度來看，91小视频可以說最長使用期限直接（jiē）取決於上下遊壓差。隻有在上下遊壓差達到一定數值影響（xiǎng）到通風（fēng）係統的性能，或者是能量需（xū）求超過過濾器（qì）更換成本時（shí），過濾器更換才有意義。但是，過濾器必須（xū）能通過泄漏測試（如上所述（shù））。事實上，很（hěn）多（duō）公（gōng）司並不（bú）會使用一個過濾器超過8年。正如前（qián）述，並沒（méi）有法規規定這樣的值（zhí），這都隻是根據經（jīng）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）容量注射（shè）劑車間（jiān）空調係（xì）統的高效過濾器必（bì）須定期更換嗎？如不（bú）定期更換，隻在空調驗證時更（gèng）換風（fēng）量不合格房（fáng）間高效和（hé）撿（jiǎn）漏不合格高（gāo）效可以嗎？

CFDA審核查驗中心回複：你好，更（gèng）換高效過濾器根據空調驗證參考：時風量和撿漏是（shì）必須的，但同時也應製定（dìng）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。同時必須定（dìng）期進行過濾器完整性（xìng）測（cè）試。

製藥廠高效過濾器一般（bān）多（duō）久更換？

潔淨區A級高效過濾器檢漏

谘詢內容：潔淨區A級高效過濾器檢漏是否可以使用 塵埃粒子計數（shù）器 掃描檢漏，如（rú）果可以，那麽判斷無泄漏的標準是多少。

CFDA審核查驗中（zhōng）心回複：靈潔高效（xiào）過濾器（qì）檢漏一般在（zài）非關鍵區域可以使用塵埃（āi）粒子計數器（qì），但A級潔淨區高效過濾器不推薦使用塵埃粒子（zǐ）計數器掃描檢漏