臨滄製藥廠高效過濾器

關於高效（xiào）過濾器的更換周期方麵的問題，很多潔淨室用（yòng）戶都（dōu）很關心，畢竟（jìng）高效過濾器決定著潔淨室的潔淨（jìng）度能否達到標（biāo）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（fāng）麵的問題：高（gāo）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（lǜ）器（HEPA）用於生產空間空氣的處（chù）理和過濾的終端過濾器。無菌（jun1）生產要求強（qiáng）製（zhì）使用高（gāo）效（xiào）過濾器，而固體（tǐ）和半（bàn）固體劑型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（jiǔ）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（kǎo）：（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（qì）一般多久更換？

草莓秋葵菠萝蜜黄瓜榴莲视频經（jīng）常看（kàn）到在公司內部文件中，要求每年（nián）更換過濾器，而不管檢測結果如何。這是否合理（lǐ）？在相關的GMP指南中並沒有高效過濾（lǜ）器可以使用期限的具體數值（zhí）。根（gēn）據GMP的要求，過濾器不得有泄漏，這需要通過確認和（hé）定期（qī）執（zhí）行ISO14644-3中的泄漏（lòu）測試，無（wú）菌車間來（lái）說這是必須的。根據附（fù）錄1（PIC/S PI032-2）的（de）技術詮釋，A/B級每6個月進行泄漏測試，C/D級則為12個月。FDA無菌指南要求進行定期（qī）檢（jiǎn）查。附錄1的要求在這裏也適用。泄（xiè）漏是可以修（xiū）補的，但修補的（de）麵積（jī）不能超過單個過濾（lǜ）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（rán），廣州靈潔淨化高效過濾器並不隻（zhī）有完整性（xìng）一件（jiàn）事情。過濾器（層）的負載以及上下遊壓（yā）差也（yě）很重（chóng）要。如果過濾器上下遊壓差升高（gāo），則（zé）送排風係統的能（néng）量需求會增加（jiā），這樣才（cái）能維持必（bì）須的換氣次（cì）數。這樣（yàng）的過濾器上下遊壓差可能會增加通風係統的性能限（xiàn）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（yàng）的精（jīng）細過濾（lǜ）器（qì）。這些過濾器必須（xū）定期更換以保護高效過濾（lǜ）器避（bì）免（miǎn）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用期限（xiàn）直接取決於上下遊壓差。隻有在上下遊壓（yā）差達到一定（dìng）數值（zhí）影響到通風係（xì）統的性能，或者（zhě）是能量需求超過過濾器更換成本時，過濾器更換才有（yǒu）意義。但是，過濾器必須能通過泄漏測試（如上所述）。事實（shí）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（guī）定這樣的值，這都隻是根據經驗得來的。

靈（líng）潔（jié）高效過濾器更換問（wèn）題

谘（zī）詢內容：老師您好，小容量注射劑車間（jiān）空調係統的高效過濾器必（bì）須定期更換嗎？如不定期更換，隻（zhī）在空調驗證時更（gèng）換風量不合格房間高效（xiào）和撿（jiǎn）漏不合（hé）格高效可以（yǐ）嗎？

CFDA審核查驗中心回複：你好，更換高（gāo）效過濾器根據空調驗證參考：時風量和撿漏是必須的，但同時也應（yīng）製定出具體（tǐ）高效過濾器（qì）最長（zhǎng）使用周期，故還是應該有定期（qī）的概念。同時必須定期進行過濾器完整性測（cè）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級高效過濾器檢漏是否可以使用 塵（chén）埃粒子計數（shù）器 掃描檢漏（lòu），如果可以，那麽判斷無泄漏的標準是多少。

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