南陽製藥廠高效過濾（lǜ）器（qì）

關於高效過濾器的更換周期方麵的問題，很（hěn）多潔淨室用戶都很關（guān）心（xīn），畢竟高效過濾器（qì）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問題：高效過濾器的（de）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（zài）製藥行業，高效過濾器（HEPA）用於生產空間（jiān）空氣的處理和過濾的終端（duān）過（guò）濾器。無菌生產要求（qiú）強製使用高效過濾器（qì），而固體和半固體劑型的生產有時也（yě）會使用。H13至H14（DIN1822）是高效過（guò）濾器的兩種，後者（zhě）截留率為99.995%。但（dàn）多（duō）久必須更換一（yī）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.

製藥廠高效過濾（lǜ）器一般多久更換？

91小视频經常看到在（zài）公司內部（bù）文件中，要求每年更（gèng）換過濾器，而不管檢（jiǎn）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（zhè）需要通過確認（rèn）和（hé）定期執行ISO14644-3中的泄漏測試，無菌車（chē）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個月進行泄漏測試（shì），C/D級則為（wéi）12個月。FDA無（wú）菌指南要求進行定期檢查。附錄1的要求（qiú）在這裏也適用。泄漏是可以修補的，但修補（bǔ）的麵積（jī）不能超過單個（gè）過濾（lǜ）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（guǎng）州（zhōu）靈潔（jié）淨化高效（xiào）過濾器並不隻有（yǒu）完整性一件事（shì）情。過濾（lǜ）器（層）的（de）負（fù）載以及上下遊壓（yā）差也很重（chóng）要。如果過濾器上下遊壓差升高，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（zhè）樣的過濾器上下遊壓差可能會增加通風（fēng）係統的性能限製。為了保護（hù）高效過濾器，就要使用前端過濾器---通（tōng）常是像F7和（hé）F9過濾器（EN779）這樣的精細過濾（lǜ）器。這些過濾器必須定期更換以保護高（gāo）效（xiào）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.

從實踐角度來看，91小视频（men）可以說最長使（shǐ）用期限直接取決於上下遊壓差。隻有在上下遊壓差達到一定數（shù）值影響到通風係統的性能，或者是能量需求超（chāo）過（guò）過濾器更換成（chéng）本時，過濾器更換才有（yǒu）意義。但是，過濾器必（bì）須能通過泄漏測試（如上（shàng）所述）。事實上（shàng），很多公司並（bìng）不會使用一個過濾器超（chāo）過8年。正如前述，並沒有法規規定這樣的值，這都隻是根據（jù）經驗得來的。

靈潔（jié）高效（xiào）過濾器更換（huàn）問（wèn）題

谘詢內（nèi）容：老師您好，小容量注射劑車（chē）間空調係統的高效過（guò）濾器必須定期更換嗎？如不定期更換（huàn），隻在空（kōng）調驗證時更換風量不合格房間高效（xiào）和撿漏不合格高效可以嗎？

CFDA審核查驗中心回複：你好，更換高（gāo）效過濾器根據空調驗證（zhèng）參考：時風（fēng）量和撿漏是必須的，但同時也應製定出（chū）具體高效過濾器最長（zhǎng）使用周期，故還（hái）是應該有定（dìng）期的概念。同時必須定（dìng）期進行過濾器完整（zhěng）性測試。

製藥廠（chǎng）高效過濾器一般多久更換？

潔淨區A級高效過濾器檢漏

谘（zī）詢（xún）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，那麽判斷無泄漏的標（biāo）準是多少。

CFDA審核查驗中心回複（fù）：靈潔高效過濾器檢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（qū）高效過濾器不推薦使用塵埃粒子計數器掃描檢漏