泰安製藥廠高效（xiào）過濾器

關於高效過濾器的更換周期方麵的問題，很多潔（jié）淨室用戶都很關心，畢竟高（gāo）效過濾器決定著潔淨室的潔淨度能（néng）否達到標準，就在前（qián）方91小视频也整理過（guò）相關方麵的問題（tí）：高（gāo）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?

在製藥行業，高效（xiào）過濾器（HEPA）用於生產空間空氣的處理和過濾（lǜ）的終端過濾器。無菌生產（chǎn）要求強製使用高效過濾器，而固體和半（bàn）固體劑（jì）型的生產有時也會使用。H13至H14（DIN1822）是高效過濾器的（de）兩（liǎng）種，後者（zhě）截留（liú）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）高效過濾器一般多久更換？

91小视频經常看到（dào）在公司內部文件（jiàn）中，要求每（měi）年更換過濾器，而不管檢測結果如何。這是否合理（lǐ）？在相（xiàng）關的GMP指南中（zhōng）並沒有高效過濾器（qì）可以使（shǐ）用期限的具體數值（zhí）。根據GMP的要求，過濾器不得有泄漏，這需要通過確認和定期（qī）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）的技術詮釋，A/B級每6個月進行泄漏測（cè）試，C/D級則為（wéi）12個月。FDA無菌指南要求進行定期檢查。附錄1的要求在這裏也適用。泄漏是可以（yǐ）修補的，但修補的麵（miàn）積不能（néng）超過單個過（guò）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（gāo）效過濾器並不隻（zhī）有完整性一件事情。過濾器（層（céng））的負（fù）載以及上下遊（yóu）壓差也很重要。如果過濾器上下遊壓差升高，則送（sòng）排風係統的（de）能量需求會增加，這樣才能維持必（bì）須的換（huàn）氣次數。這樣的過濾器上下遊壓差（chà）可能會增加通風係統的（de）性能限製。為了保護高效過濾器，就（jiù）要使用前端過濾器---通常是像（xiàng）F7和F9過濾器（EN779）這（zhè）樣的精細過濾器。這些（xiē）過濾器必須定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，91小视频可以說最長使用期限直接取決於上下遊壓差。隻有在上下遊壓差達到一（yī）定數值影響到通風係統的性能，或者是能量需求（qiú）超過過濾器更換成（chéng）本時，過濾器更換才有意義。但是，過（guò）濾器必須能通過（guò）泄漏測試（如上所述）。事（shì）實上，很多公（gōng）司並不會使用（yòng）一個過濾器（qì）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（jù）經驗得來的。

靈（líng）潔高效過濾器更換問題

谘詢內容：老師您（nín）好，小容量注射劑車（chē）間空調係統的高效過濾器必（bì）須定期更換嗎（ma）？如（rú）不定期更換，隻在空調驗證（zhèng）時更換風量不合格房間高（gāo）效和撿（jiǎn）漏不合格高效可以嗎？

CFDA審核查驗中心（xīn）回複：你好，更換高效（xiào）過濾（lǜ）器根據空調驗證參考：時風量和撿漏是必須的（de），但同時（shí）也應製（zhì）定出具體高效過濾（lǜ）器最長使用周期，故還是應該有定期的（de）概念。同時必須定期進行過濾器完整（zhěng）性測試。

製藥（yào）廠高（gāo）效過濾器一般多久更換？

潔淨區A級高效過濾器檢漏

谘詢內容：潔（jié）淨區A級高效（xiào）過濾（lǜ）器檢（jiǎn）漏是（shì）否可以使用 塵埃粒子計數器 掃（sǎo）描檢漏，如果可以，那麽判斷無泄（xiè）漏的標準是多少。

CFDA審（shěn）核查（chá）驗中心回複：靈潔高效過濾器檢漏一般在非關鍵區域可以（yǐ）使用塵埃粒子計數器（qì），但A級潔（jié）淨區高效過濾器不推薦使用塵埃粒子計數器掃描檢漏（lòu）