貴港製藥廠高效過濾器

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（hěn）關心，畢竟高效過（guò）濾器（qì）決（jué）定著潔淨室的潔淨度能否達到（dào）標準，就在前方嫩草影院也整理過相關（guān）方麵（miàn）的問題：高效過濾器的更換標（biāo）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）用於生產空間空氣的處理（lǐ）和過（guò）濾的終端過濾器。無（wú）菌生產要求強製使用高效過濾器，而固體和半固體劑型的（de）生產有時也會使用。H13至H14（DIN1822）是（shì）高效過濾器的兩種，後者截留率為99.995%。但多久必須更換一（yī）次呢（ne）？

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（gāo）效過濾器一般多久更換？

嫩草影院經常看到在公（gōng）司（sī）內部文件中，要求每年更（gèng）換過濾器，而不管檢測結果如何。這是否（fǒu）合理？在相關（guān）的GMP指南中並沒有高效過濾器可以使用期限（xiàn）的具體數值。根（gēn）據GMP的（de）要求，過（guò）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（cè）試，無菌車間來說這是必（bì）須的。根據附錄1（PIC/S PI032-2）的技術詮釋，A/B級（jí）每6個月進行泄漏測試，C/D級則為（wéi）12個月。FDA無（wú）菌指南要求（qiú）進行定期檢查。附錄1的（de）要求在這裏（lǐ）也適用。泄漏是可以修補的，但修補的麵積不（bú）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（guò）濾器並不隻有完（wán）整性一件事情。過濾器（qì）（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（gāo），則送排風係統的（de）能量需求會增加，這樣才能維（wéi）持必（bì）須的換氣次數。這樣的過濾器上下遊壓差可能會（huì）增加（jiā）通（tōng）風係統的性（xìng）能限製。為了保護高效過濾器，就要使用前端過濾器---通常是像F7和F9過濾器（EN779）這樣的精細過濾器。這些過濾器必須（xū）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，嫩草影院可以說最長使用期限直接取（qǔ）決於上下遊壓差。隻有在上下遊壓差達（dá）到一（yī）定數值（zhí）影響到（dào）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（guò）濾器更換才有意義。但是，過濾器（qì）必須能通（tōng）過泄漏測試（如上所述）。事實上，很多公司並不會使用一個過濾器超過（guò）8年。正如前述，並沒有法規規定這樣的值，這都隻是根據經驗得來的。

靈潔高（gāo）效過濾器更換問題

谘詢內（nèi）容：老師您好，小容量注射劑車間（jiān）空（kōng）調係統的高效過濾器必須定期更換嗎？如不定期更換，隻在空調驗證時更換風量不合格（gé）房（fáng）間高效和撿漏（lòu）不合格高效可以嗎？

CFDA審（shěn）核查驗中心回複（fù）：你好（hǎo），更換高效過濾器根據空調（diào）驗證參考：時風量和撿漏是必須（xū）的，但同時（shí）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。同時必（bì）須定期進（jìn）行過（guò）濾器完整性測試。

製藥廠高效過濾器一般多久更換？

潔淨區A級高效過濾器檢漏

谘詢內容：潔淨區A級高效過（guò）濾器（qì）檢漏是否可以使（shǐ）用（yòng） 塵埃粒子（zǐ）計數器 掃描檢（jiǎn）漏，如果可以，那（nà）麽判斷無泄漏的標準是多少。

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（jiàn）區域可以使用塵（chén）埃粒子（zǐ）計數器，但A級潔淨區高（gāo）效過濾器不推薦使用塵埃粒子計數器（qì）掃描（miáo）檢漏