賀州製藥廠高效過濾器

關於高效過濾器的更換周（zhōu）期方（fāng）麵的問題，很多潔淨室用戶（hù）都很關心，畢竟高效過濾（lǜ）器決定著潔淨（jìng）室的潔淨度能否達（dá）到標準，就在前方草莓秋葵菠萝蜜黄瓜榴莲视频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?

在製藥行業，高效（xiào）過濾器（HEPA）用（yòng）於（yú）生產空間（jiān）空氣的處理（lǐ）和過濾的終端過濾器。無菌生產要求強製使用高（gāo）效過濾器，而固體和半固體劑型（xíng）的生產有時也會使用。H13至H14（DIN1822）是高效過濾器的兩種，後者截留率為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：（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（jiǎn）測結果如（rú）何。這是（shì）否（fǒu）合理？在相關的GMP指（zhǐ）南中並沒有高效過濾器可（kě）以使用期限（xiàn）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（zhí）行ISO14644-3中的（de）泄漏測試（shì），無菌車間來說（shuō）這是必須的。根據附錄1（PIC/S PI032-2）的（de）技術詮（quán）釋（shì），A/B級每6個月進行泄漏測試，C/D級則（zé）為12個月。FDA無菌指南要求進行（háng）定期檢查。附錄（lù）1的要求在這裏也適用。泄漏是可以修（xiū）補的，但修補的麵積不能（néng）超過（guò）單（dān）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（bú）隻有完整性一件事情。過濾器（層）的負（fù）載以及上下遊壓差也很重要。如果過濾（lǜ）器上下（xià）遊壓差升（shēng）高，則送排風係統的能量需求會增（zēng）加，這樣才（cái）能維持必須的換氣次數（shù）。這樣的過濾器上下遊壓差可能會增加通風係（xì）統的性（xìng）能（néng）限製。為了保護高（gāo）效過濾（lǜ）器，就要使用（yòng）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（qì）必（bì）須定期更（gèng）換以保（bǎo）護高效過濾器（qì）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（shí）踐角度來看，草莓秋葵菠萝蜜黄瓜榴莲视频可以（yǐ）說最長使用期限（xiàn）直接取決於上下遊（yóu）壓差。隻有在上下遊壓差達到一（yī）定（dìng）數值影響到（dào）通風係統的性能，或（huò）者是能量需求超過過濾（lǜ）器更換成本時，過濾（lǜ）器（qì）更換才有意義。但是，過濾器必須能通過泄漏測試（如上所述）。事實上，很多公司並不（bú）會使（shǐ）用一個過濾器超過8年。正（zhèng）如前述，並沒（méi）有法規規定這樣的（de）值，這都隻是根據經驗得來的。

靈潔高（gāo）效（xiào）過濾器更換問（wèn）題

谘（zī）詢內容：老師您好，小容量注射（shè）劑車（chē）間空調係統的高效（xiào）過濾器必須定期更換嗎？如（rú）不定期（qī）更換（huàn），隻在空調驗證時（shí）更換風量不合格房間高效和撿漏不合格高效可以嗎？

CFDA審核查驗中心回複：你好，更換高效過濾器根據（jù）空調驗證參考：時風量和撿漏是必須的，但同時也應製定出具體高效過濾（lǜ）器最長使用周期，故還是應該有定期的概念。同時必須定期進行過濾器完整性測試。

製藥廠高效過濾器一般多久更換？

潔淨區（qū）A級高（gāo）效過濾器（qì）檢漏

谘詢內容：潔（jié）淨區（qū）A級高效過濾器檢漏是否可以使用（yòng） 塵埃粒子計（jì）數器（qì） 掃（sǎo）描檢（jiǎn）漏，如果可以，那麽判斷無泄漏的標準是多少。

CFDA審核查驗中心（xīn）回複：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（qì），但（dàn）A級潔淨區高效過濾（lǜ）器不推薦使（shǐ）用塵埃粒子計數（shù）器掃描檢漏