焦作製（zhì）藥廠高效過濾器

關於高效過濾器的更換周期方麵的問題，很多潔淨室用戶都很關心，畢竟高效過濾器決定（dìng）著潔淨室的潔（jié）淨度能否達到標準，就在前方（fāng）91小视频也整理過相關方（fāng）麵的問題：高效過濾器的更（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，高效過濾器（qì）（HEPA）用於生產（chǎn）空間空氣的處理和過濾的（de）終端過濾器（qì）。無菌生產要求強製使（shǐ）用高效過濾（lǜ）器，而固體和半（bàn）固體劑型的生產（chǎn）有（yǒu）時也會使用。H13至H14（DIN1822）是高效過濾器的兩種，後（hòu）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（cān）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（yào）廠高效過濾（lǜ）器一般多久更換？

91小视频（men）經常看到在公司（sī）內部文件中，要求（qiú）每年更換過濾器，而不（bú）管檢（jiǎn）測結（jié）果如何。這是否合理？在相關的GMP指南中（zhōng）並沒有高效過濾器可以使用期限的具體數值。根據（jù）GMP的要（yào）求，過濾器不得有泄漏，這需要通過確認和定期執行ISO14644-3中的泄漏測試，無菌車（chē）間來說（shuō）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（xiè）漏測試，C/D級則為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（kě）以修補的，但修補的麵積不能超（chāo）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（jié）淨化高效過濾器並不隻有（yǒu）完整性一件事情。過濾器（層）的負載以及上下遊壓差也很重要。如果過濾器上下遊壓差升高，則送排風係統的能量（liàng）需求會增加，這樣才能維持（chí）必須的換氣次（cì）數。這樣的過濾（lǜ）器（qì）上下（xià）遊壓差可能會增加通風係（xì）統的性能（néng）限製（zhì）。為了保護高效過濾器，就要使用前端過（guò）濾器---通常是像F7和F9過（guò）濾器（EN779）這樣的精細過濾器。這些過濾器必須定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（cóng）實踐角度來看，91小视频可以說（shuō）最長使用期限直接取決（jué）於上下遊壓差。隻有（yǒu）在上下遊壓差（chà）達到一定數值（zhí）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（lǜ）器（qì）更（gèng）換才有意（yì）義。但是，過濾（lǜ）器必須能通過泄漏測（cè）試（如上所述）。事（shì）實上，很多公司並不會（huì）使用一個（gè）過濾器超過8年。正如前述，並沒有法規規定（dìng）這樣的值，這都隻是（shì）根據經（jīng）驗得來的。

靈潔高效過濾器更（gèng）換問題

谘詢內容：老師您好，小容量注射劑（jì）車間空（kōng）調係統的高效過濾器必（bì）須定期更（gèng）換嗎？如不定期更換，隻在空調驗證時更換風量不合格房間（jiān）高效和撿漏不（bú）合格高效（xiào）可以嗎？

CFDA審核查驗中心回複：你好，更換高效過濾器根（gēn）據空調驗（yàn）證參考：時風量和撿（jiǎn）漏是必須的，但同時也（yě）應製定（dìng）出具體高效過濾器最長使用周期，故還是應該有（yǒu）定期的概念。同時必須定期進行過（guò）濾器完整性測試。

製藥廠高（gāo）效（xiào）過濾器一般多久更換？

潔淨區A級高效過濾器（qì）檢漏

谘詢內容：潔淨區A級（jí）高效過濾器檢漏是否可以使用 塵埃粒子計數器 掃描檢漏，如果可以，那麽判斷無（wú）泄漏的標（biāo）準是（shì）多少。

CFDA審核查驗中心（xīn）回複：靈潔高效過濾器（qì）檢漏一般在非關（guān）鍵（jiàn）區域可以使用塵埃粒子計數器，但A級（jí）潔淨區高效過濾器不推薦使用塵埃粒子計數器掃描檢漏