萍鄉製藥廠高（gāo）效過濾器

關（guān）於高（gāo）效（xiào）過濾器（qì）的更換周（zhōu）期方（fāng）麵的問題，很多潔淨（jìng）室用戶都（dōu）很關（guān）心，畢竟高（gāo）效過（guò）濾器決定（dìng）著潔（jié）淨室的潔淨度能否達到（dào）標準，就（jiù）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（xiào）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。無菌生產要求強製（zhì）使用高效過濾器，而（ér）固體和半固體劑型的生產有時也（yě）會使（shǐ）用。H13至（zhì）H14（DIN1822）是（shì）高效過濾器的（de）兩種，後者截留率為99.995%。但多久必（bì）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（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（xiào）過濾器一般多（duō）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（měi）年更換過濾器，而不管檢測結果如何。這是否合理？在相關的GMP指（zhǐ）南中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，過濾器不得有泄漏，這需（xū）要通過（guò）確認和定期執行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12個月。FDA無菌指南要求進行定（dìng）期檢查。附錄1的（de）要求在這裏也適用。泄漏是（shì）可（kě）以修補（bǔ）的，但修補的麵積（jī）不能超過單個（gè）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（xiào）過濾器並不隻有完整性一件事情。過濾（lǜ）器（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，則送排風係統的能量需求會（huì）增加，這樣才能維持必須的換氣次數。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。為了保護（hù）高效過濾器，就要使用前端（duān）過濾（lǜ）器---通常是（shì）像F7和F9過濾器（EN779）這樣的精細過濾器。這些過濾（lǜ）器必須定期更換以保護高（gāo）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.

從實（shí）踐角度來看，草莓秋葵菠萝蜜黄瓜榴莲视频可以說最長使（shǐ）用期限直接取決於上下遊壓差。隻有在上下遊（yóu）壓差達到（dào）一定數值影響到通風係統的性能，或者是能量需求超（chāo）過過濾器更換成本（běn）時（shí），過（guò）濾器更換才有意義。但是，過濾器必須能通過泄（xiè）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8年。正如前述，並沒有法規規定這樣的（de）值，這（zhè）都隻是（shì）根據經驗得（dé）來的。

靈潔高效過濾器（qì）更換問題

谘詢內容：老師您好，小（xiǎo）容量注射劑車間空調係統的高效過濾器必須（xū）定期更換嗎（ma）？如（rú）不定期更換，隻在空調驗證時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（huí）複：你好，更換高效過濾器根據空調驗證參考：時風量和撿漏是必須（xū）的，但同時也應製定出具（jù）體高效過濾（lǜ）器最長使（shǐ）用（yòng）周期（qī），故還是應（yīng）該有定期的概念。同時必須定期進（jìn）行過濾（lǜ）器完整（zhěng）性測試。

製藥（yào）廠高效過濾器一（yī）般多久（jiǔ）更換？

潔淨（jìng）區（qū）A級高效過濾器檢漏

谘詢內容：潔淨區（qū）A級高效過濾器檢漏是否可以（yǐ）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準是多（duō）少。

CFDA審核查驗中心回複：靈（líng）潔高效過濾器檢漏一（yī）般在非關鍵（jiàn）區域可以使用塵埃粒子計數器，但A級潔（jié）淨（jìng）區高效過濾器不推薦使用塵埃粒子計數器掃描（miáo）檢漏