徐州製藥廠高效過濾器

關於高效過濾器的更換周（zhōu）期方麵（miàn）的問題，很多潔淨室用戶都很關（guān）心，畢竟高效過（guò）濾器決（jué）定（dìng）著潔淨室的（de）潔淨度能否達到（dào）標準，就在前方91小视频也整理過相關（guān）方麵的問題：高效過濾器的更換標準（zhǔn）

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（zài）製藥行業，高效（xiào）過濾器（HEPA）用於生產（chǎn）空間空（kōng）氣的處理和過濾的終端過濾器。無菌生產要求強（qiáng）製使用高（gāo）效過濾器，而固體和半固體（tǐ）劑型的生產有時也會使（shǐ）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（zhì）藥廠高效過濾器一般多久更換？

91小视频經常看到在公司內部文件中，要求每年更換過濾器，而不管檢測結果如何。這是否合理？在相關的GMP指南中（zhōng）並沒有高效過濾器（qì）可以使用期限的具體數值。根據GMP的要求，過濾器不得有泄（xiè）漏，這需要（yào）通過確認和定期執行ISO14644-3中的泄漏測試，無菌車間（jiān）來說這是必須的。根據附錄1（PIC/S PI032-2）的技術（shù）詮（quán）釋，A/B級每6個（gè）月（yuè）進行泄漏測試，C/D級則為12個月（yuè）。FDA無菌（jun1）指南要求進行定期（qī）檢查。附錄1的要求在這裏也適用。泄漏是可以修補的，但修補的麵積不能超過單個過濾器（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（rán），廣州靈潔淨化高效過（guò）濾器並不隻有完整性一件事情。過濾器（層（céng））的（de）負載以及上下遊壓差也很重（chóng）要。如果過濾（lǜ）器上（shàng）下遊壓（yā）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氣次數。這樣的過濾器上下遊壓（yā）差可能會（huì）增加通風係（xì）統的性（xìng）能（néng）限製。為了保護高效過濾器，就要使用前端過濾器---通常是像（xiàng）F7和F9過濾器（EN779）這樣的精細過濾器。這（zhè）些過（guò）濾器必須定期更換以保護高效過濾器避免堵（dǔ）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（lái）看，91小视频（men）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到通風係統的性能，或者是能量需求超（chāo）過過濾器更換成本時，過濾器更換才有意義。但是，過濾器必須能通過泄漏測試（如上所述）。事實（shí）上，很（hěn）多公司並不會使用一個過濾器超（chāo）過8年。正如前述（shù），並沒有法規（guī）規定這（zhè）樣的（de）值，這（zhè）都隻（zhī）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（hǎo），小容量注射劑車間空調係（xì）統的（de）高效（xiào）過濾器必須定期（qī）更換嗎？如（rú）不定期更換（huàn），隻在空調驗證時更換風量（liàng）不合格房間高效和撿漏不合格高效可以嗎？

CFDA審（shěn）核查驗中心回複：你好，更換（huàn）高效過濾器根據空調驗（yàn）證參考：時風量和撿漏是必（bì）須的，但同（tóng）時也應製定出具（jù）體（tǐ）高（gāo）效過濾器（qì）最長（zhǎng）使用周期，故還是應該有定期（qī）的概念。同時必須定期進行過濾（lǜ）器完整性測試。

製藥廠高效（xiào）過濾（lǜ）器一般多久（jiǔ）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（fǒu）可以使用（yòng） 塵埃粒（lì）子計數（shù）器 掃描檢漏，如果可以，那（nà）麽判斷無泄漏（lòu）的標準是（shì）多少。

CFDA審核查驗中心回複：靈潔高效過濾器檢漏一般（bān）在非關鍵區域可以使用（yòng）塵埃粒子計數器，但A級潔淨區高效過濾器不推薦（jiàn）使用塵埃粒子計數器掃描檢漏