延安製藥廠高效過濾器

關於高效過濾器的更換周期方麵的問題，很多潔淨室用戶（hù）都很關心，畢竟高效過濾器決定著潔淨室的潔淨度能否達到標準，就在前方草莓秋葵菠萝蜜黄瓜榴莲视频也整理過相關方麵（miàn）的問題：高效過濾器的更換（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?

在製藥（yào）行業，高效過濾器（HEPA）用（yòng）於生產空間空氣的（de）處理和（hé）過濾的終（zhōng）端（duān）過濾器。無菌生產（chǎn）要（yào）求強製使用高效過（guò）濾器，而固體和半固體劑型的生產有時也會（huì）使用。H13至H14（DIN1822）是高效過濾器的兩種，後者截（jié）留率為99.995%。但多久必須更換一（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）過濾器一（yī）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（yào）求每年更換過濾器，而不管檢測結果如何。這是否（fǒu）合理？在（zài）相關的GMP指南中並沒有高效過濾器可以使用（yòng）期（qī）限的具體數值。根據GMP的要求，過濾器（qì）不得有泄漏，這需要通過確認和定期執行ISO14644-3中的泄漏測試，無菌車間來說這（zhè）是必須的。根據附（fù）錄1（PIC/S PI032-2）的技術詮釋（shì），A/B級（jí）每6個月進行泄漏測試，C/D級則為12個月。FDA無（wú）菌指南要求進行（háng）定期檢查。附錄1的（de）要求在這裏也適用。泄漏是可以（yǐ）修補的，但修補（bǔ）的麵積不能超（chāo）過單個過濾器麵（miàn）積的（de）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（jìng）化高效過濾器（qì）並（bìng）不隻有完整性一件事情。過濾器（層）的負載以及上（shàng）下遊壓（yā）差也（yě）很重要。如果過濾器上下遊壓差升高，則（zé）送（sòng）排風係統的能（néng）量需求會增加，這（zhè）樣才能維持必須的換氣（qì）次數。這樣的（de）過濾器上下遊壓差可能會增加通風係統（tǒng）的性能限（xiàn）製。為了保護高效過濾器（qì），就要使用前端過濾器---通常是像（xiàng）F7和F9過濾（lǜ）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.

從實踐角度來看，草莓秋葵菠萝蜜黄瓜榴莲视频（men）可以說最（zuì）長使用期限直接（jiē）取決於（yú）上下遊壓差。隻有在上下遊壓差達到一定數值影響到通（tōng）風係統的性能，或者是能量需求超過過濾器（qì）更換成本時，過濾（lǜ）器更換才有意義。但是，過濾器（qì）必須能通過泄漏測試（如上所（suǒ）述）。事實上，很多公司並（bìng）不會使用（yòng）一個過濾器超過8年。正如前述，並沒（méi）有法規規定（dìng）這樣的值（zhí），這都隻是（shì）根據經驗得來的。

靈潔高效（xiào）過（guò）濾器更換問（wèn）題

谘詢內容：老師您好，小容量注射劑車間空（kōng）調係統的高（gāo）效過濾器必須（xū）定期更換嗎？如不定期更換，隻在空調驗證（zhèng）時（shí）更換風（fēng）量不合格房間高效（xiào）和撿漏不合（hé）格高效可以嗎？

CFDA審核查驗（yàn）中心（xīn）回複：你好，更換高效過濾器根據空調驗證參考：時風（fēng）量和撿漏是必須的，但（dàn）同時（shí）也應製（zhì）定出具體高效過濾（lǜ）器（qì）最長使用周期，故還是應該有定期的概念。同時必須定期（qī）進行過濾器完整性（xìng）測試。

製（zhì）藥廠高效過濾器一般多（duō）久更換？

潔淨區A級高效過濾（lǜ）器檢漏

谘詢內容：潔淨區A級高效（xiào）過濾器檢漏是否可以使用 塵埃粒子計數器 掃（sǎo）描（miáo）檢漏（lòu），如果可以，那麽判（pàn）斷無泄漏的標準是多少。

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