陝西製藥廠高（gāo）效過濾器

關於高效過濾器的更換周期方麵的問（wèn）題（tí），很（hěn）多（duō）潔淨室用戶都很關（guān）心，畢竟高效過濾器決定（dìng）著潔淨室的（de）潔淨度能否達到標準，就在前方（fāng）嫩草影院也整理過相關方麵的問題：高效過（guò）濾器（qì）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，高效過濾器（HEPA）用於生產空間空氣的處理和過濾的終端過濾器。無菌生（shēng）產要求（qiú）強（qiáng）製使用高效過濾器，而固體（tǐ）和半（bàn）固（gù）體劑型的生產（chǎn）有時也會使用。H13至H14（DIN1822）是高效（xiào）過濾器（qì）的兩種，後者截留率為（wéi）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.

製藥廠高效過濾器一般多久更換？

嫩草影院經常看到在公司內部文件中，要求每年（nián）更換過濾器，而不（bú）管檢測（cè）結（jié）果如何（hé）。這是否合理？在相關的（de）GMP指南中並（bìng）沒有高效過濾器可以使用期（qī）限的具體數值。根據GMP的要求，過濾器不得有泄漏，這需要通過確認和定期執行ISO14644-3中（zhōng）的泄漏測試，無菌車（chē）間來說這是（shì）必須的。根據附（fù）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（yào）求進行定期檢查。附錄1的要求在這裏也適用。泄漏是（shì）可以修（xiū）補（bǔ）的，但修補的麵（miàn）積不能超過單個過濾器麵積的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，廣州靈潔淨化高效過濾器並不隻有完整性一件事情。過濾器（層（céng））的負載以及上下遊（yóu）壓差也很重要。如果過濾器上下遊壓差（chà）升高，則送排風（fēng）係統的能量需求會增加，這樣才能維持（chí）必須的換氣次數。這樣的過濾器上下遊壓差可能會增加通風係統的性能限製。為了（le）保護高效過濾器，就要使用前端（duān）過濾器---通常（cháng）是像F7和F9過（guò）濾器（EN779）這樣的精細過濾器。這些過（guò）濾器必須定期更換以保護高（gāo）效過（guò）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.

從實踐角度來看，嫩草影院可以說最（zuì）長使用期限直接取決於上下遊壓（yā）差。隻有在上下遊壓差達到（dào）一定數值（zhí）影（yǐng）響到通風係統的（de）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（cái）有意義。但是，過濾器必須能通過泄漏測試（如上所述（shù））。事（shì）實上，很多公司並不會（huì）使用一個過（guò）濾器超過8年。正如前述，並沒有法規規定這樣的值，這都隻是（shì）根據經驗得來的（de）。

靈潔（jié）高效過（guò）濾器更換問題

谘詢內容：老師您好（hǎo），小（xiǎo）容量（liàng）注射劑車間（jiān）空調係統的高效過濾器必須（xū）定期更換嗎？如（rú）不（bú）定期更換，隻在空調驗證時更（gèng）換風（fēng）量不（bú）合格房間高效和（hé）撿漏不合格高效可以嗎？

CFDA審核查驗中（zhōng）心回複：你好，更換高效過濾器根據空調驗證參考（kǎo）：時風量和撿漏是必須的，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（yīng）該有定期的概（gài）念。同時必須定期進行過濾器完（wán）整性測（cè）試（shì）。

製藥廠高效過濾器一（yī）般多久更換？

潔淨區A級高效過濾器（qì）檢（jiǎn）漏

谘詢內（nèi）容：潔淨區A級高效過濾器檢漏是否可以使用 塵（chén）埃粒子計（jì）數器 掃描檢漏，如果可以，那麽判斷（duàn）無泄漏的（de）標準是多少（shǎo）。

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