鄭州製藥廠高效過濾（lǜ）器（qì）

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關心，畢竟高（gāo）效過濾器決定著潔淨室的潔（jié）淨度能否達到（dào）標準，就在（zài）前方草莓秋葵菠萝蜜黄瓜榴莲视频也整理（lǐ）過相關方麵的問題：高（gāo）效過濾器的更換（huàn）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（zài）製藥行業，高效過濾器（HEPA）用於生（shēng）產空間空氣的處（chù）理和過濾的終端過濾器。無菌生（shēng）產要（yào）求強製使用（yòng）高效過濾器（qì），而固體和半固體劑型的生產有時也會使用。H13至H14（DIN1822）是高效過濾器（qì）的（de）兩種，後（hòu）者截留率為（wéi）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（yào）廠高效過濾器一（yī）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（nián）更換過濾器，而不管檢測結（jié）果（guǒ）如何。這是否合理？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（jù）體數值。根據GMP的要求，過濾器不得有泄漏，這需要通（tōng）過確認和定期執行ISO14644-3中（zhōng）的泄（xiè）漏測試，無菌車間來說這是必須的。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，C/D級則為12個月。FDA無菌指南要（yào）求進行定期檢查。附錄（lù）1的要求（qiú）在這裏也適用。泄漏是可以修補的，但修補的麵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（rán），廣州（zhōu）靈潔淨化高效過濾（lǜ）器並不（bú）隻有完整性一件事情。過濾器（層（céng））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（pái）風係統的能（néng）量（liàng）需求（qiú）會增加，這樣才能維持必須（xū）的換氣（qì）次數。這（zhè）樣的過濾器上下遊壓差可能會增（zēng）加通（tōng）風係統的性能限製。為了保護高效過濾器，就要使用前端（duān）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（shí）踐角（jiǎo）度（dù）來（lái）看（kàn），草莓秋葵菠萝蜜黄瓜榴莲视频可以說最長使用期限直接（jiē）取決於上下遊壓差。隻有在上下（xià）遊壓差達到一定數值影響到通風係統的性能（néng），或者是能量需求超過過濾器更換成本（běn）時，過濾器更換才有意義。但是，過濾（lǜ）器必須能通過泄漏測試（如上所述）。事實上，很（hěn）多公司並不會使用一個過濾（lǜ）器超（chāo）過8年。正如前述，並沒有法規規定這樣的（de）值，這都隻是根據經驗得來（lái）的。

靈潔（jié）高效過濾器更換問題

谘詢內容：老（lǎo）師您好，小容（róng）量注射劑車間空調係統的高效過濾器必須定期更換嗎？如不（bú）定期更換，隻在空（kōng）調驗證時更換風量不合格房間高（gāo）效（xiào）和撿漏不合格（gé）高效可以嗎？

CFDA審核查驗中心回複：你好，更換高（gāo）效過濾器根據空調驗（yàn）證參考：時（shí）風量和撿漏是必須的，但同時（shí）也應製定出具體高（gāo）效過濾器最長使用周期，故還是應該有（yǒu）定（dìng）期（qī）的概念。同時必須定期進行過濾器（qì）完整性測試。

製藥（yào）廠高效過濾器一般多久更換？

潔淨區A級（jí）高（gāo）效過濾器（qì）檢漏

谘詢內容：潔（jié）淨區A級高效過濾（lǜ）器檢漏是否可（kě）以使用 塵埃粒子（zǐ）計數器 掃描檢漏，如果可以，那麽判斷無泄漏的標（biāo）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，但A級潔（jié）淨區高效過濾器不推薦使用塵埃粒子計數器掃描（miáo）檢漏