南陽製藥廠高效過濾器

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（bì）竟高效過濾器決定著潔淨室的潔淨度能否達到標準，就在前方我（wǒ）們（men）也整理過相關方麵的問題：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（zhì）藥行業，高效過濾器（HEPA）用（yòng）於生產空間空氣的處理（lǐ）和過（guò）濾的終端過濾器。無菌生產要求強製使用（yòng）高效過濾器（qì），而固體和半（bàn）固體劑型的生產有時也會（huì）使用。H13至H14（DIN1822）是高（gāo）效過濾器（qì）的兩（liǎng）種，後者截留（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（cān）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（guò）濾器一般多久更換？

草莓秋葵菠萝蜜黄瓜榴莲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（zài）相關的（de）GMP指南中並沒有高效（xiào）過濾器可以使用期限的具體數值。根據GMP的（de）要求，過濾器不（bú）得有泄漏，這需要通過確認和定期執行ISO14644-3中的泄（xiè）漏測試，無菌車間來說這（zhè）是必須的。根據附錄1（PIC/S PI032-2）的技（jì）術詮釋（shì），A/B級每6個月（yuè）進（jìn）行泄漏測試，C/D級則為12個月。FDA無菌（jun1）指（zhǐ）南要求進行定期檢查（chá）。附錄1的要求在這裏也適用。泄（xiè）漏（lòu）是可以修補的，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（guǎng）州靈潔淨化高效過濾器並不隻有完整性一（yī）件事情。過濾器（層）的（de）負載（zǎi）以及上下遊壓差也很（hěn）重要。如果過濾器（qì）上下遊壓差升高（gāo），則送排風係統的能（néng）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（huì）增加通風係統的性能限（xiàn）製。為了（le）保護高（gāo）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（yàng）的精細過濾器。這（zhè）些過濾器必須定（dìng）期更換以保護高效過（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（kàn），我（wǒ）們可以說最長使用期限直接取決於上（shàng）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（tǒng）的性能，或者是能量需求（qiú）超過過（guò）濾器更換成本時，過濾器更換才有（yǒu）意義。但是，過（guò）濾器必須能通過泄漏測試（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。

靈潔高效過濾器更換（huàn）問題

谘詢內容：老師您（nín）好，小容量注射劑車間空調係統的高效過濾器必須定期（qī）更換嗎？如不定期（qī）更換，隻在空調驗證時更換風量不合格（gé）房間高效（xiào）和撿漏（lòu）不合（hé）格高效可以嗎？

CFDA審核查驗中心（xīn）回複：你好，更換高（gāo）效過（guò）濾器根據空調驗證參考：時風量和撿漏是必（bì）須的，但同時也應製（zhì）定出具體高效過濾器最長使（shǐ）用（yòng）周（zhōu）期（qī），故還是應該有定期的（de）概念（niàn）。同時必須定期進行過濾器完（wán）整性測試（shì）。

製藥廠高效過濾器一般多久更換？

潔淨區A級高效過濾器（qì）檢漏

谘詢內容：潔（jié）淨區A級高效過濾器檢漏是否可以（yǐ）使用 塵（chén）埃粒子計數器 掃描檢漏，如果可以，那麽判斷無泄漏（lòu）的（de）標準是多少。

CFDA審核查驗中心回（huí）複：靈潔（jié）高效過濾（lǜ）器檢漏一般在非關鍵區域可以使用塵埃粒子計數器，但A級潔淨區高（gāo）效（xiào）過濾器（qì）不推薦使用（yòng）塵埃粒子計數器掃（sǎo）描檢漏