懷化（huà）製藥廠高效過濾器

關於高效過濾器（qì）的更換周期方麵的問題，很多（duō）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（guò）相關方麵的問題：高效過濾器的更換標準

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（guò）濾器（HEPA）用於生產空間空氣（qì）的處理和（hé）過濾的終端過濾（lǜ）器。無菌生產要求強製（zhì）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用。H13至H14（DIN1822）是高效過濾器的兩種，後者截（jié）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（kǎo）：（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（xiào）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（qì），而不管檢測（cè）結果（guǒ）如何（hé）。這是否合理（lǐ）？在相（xiàng）關的GMP指南中並沒有高效過濾器可以使用期（qī）限的（de）具體數值。根據GMP的要求，過濾器不得有泄漏，這（zhè）需（xū）要通過確認和定期執行ISO14644-3中（zhōng）的泄漏測試，無菌車間來說這是必須的（de）。根據附錄1（PIC/S PI032-2）的技術詮釋（shì），A/B級每6個月進（jìn）行泄漏測試，C/D級則為12個月（yuè）。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。泄漏是可以修補的（de），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，廣州靈潔淨化高效過濾器並不隻有完整性一件（jiàn）事情。過濾（lǜ）器（層）的負載（zǎi）以及上下遊（yóu）壓差也很重要。如果過濾器（qì）上下遊壓差升高，則送排風係（xì）統的能量需求會增加，這樣才能維持必須（xū）的換氣次數。這樣的過濾器上下遊壓差（chà）可能會增（zēng）加通風係統（tǒng）的性能（néng）限製。為了保護高效過（guò）濾器，就要使用前（qián）端過濾（lǜ）器---通常是像F7和F9過（guò）濾器（EN779）這樣的精細（xì）過濾器。這些過（guò）濾（lǜ）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（yòng）期限直接取決於上下遊壓差（chà）。隻有在上下遊壓差達到一（yī）定數值影響到通風（fēng）係統（tǒng）的性能，或者是能（néng）量需求（qiú）超過過濾器更換成本時，過（guò）濾器更換才有（yǒu）意義。但是，過濾器必（bì）須能通過泄漏測試（如上所述）。事實上，很多公司並不會使（shǐ）用一個過濾器超過8年。正（zhèng）如前述，並沒有法規規定這樣的值（zhí），這都隻是（shì）根據經驗得來的。

靈潔高效過濾器（qì）更換問題

谘詢內容：老師（shī）您好（hǎo），小容量注射劑車間空調係統的高效過濾器（qì）必須定期更換嗎？如不定期更換，隻在空調驗證時更換風量不合格房間高（gāo）效和撿漏不合格高（gāo）效可以嗎？

CFDA審核查驗中心回複（fù）：你好（hǎo），更換高效過濾器根據空（kōng）調（diào）驗證參考：時風量和（hé）撿（jiǎn）漏是必（bì）須的，但同時也應製定出具體高效過濾器最長使用周期，故還是應該有定期的概念（niàn）。同時必須定（dìng）期進行過濾器完整性測試。

製藥（yào）廠高效（xiào）過濾器一般多（duō）久更換？

潔（jié）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 塵埃粒子計數器 掃描檢漏，如果可以，那麽判斷（duàn）無泄漏的標準是多少。

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