晉城製藥廠（chǎng）高效過濾器

關於高效過濾器的更換周期方麵（miàn）的問題，很多潔淨室用戶都很關心，畢竟高效過濾器決定著潔淨室的潔淨度能否達到標（biāo）準，就在前方草莓秋葵菠萝蜜黄瓜榴莲视频也（yě）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，高效過濾器（HEPA）用於生產空（kōng）間空氣（qì）的處理和過濾的（de）終端過（guò）濾器。無菌生產要求強製使用高效過濾（lǜ）器，而固體和（hé）半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（hòu）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，要求每年更換過（guò）濾器（qì），而不管檢測結果如何。這是否合理？在相關的GMP指南中並沒有（yǒu）高（gāo）效過濾器可以使用期限的具體數（shù）值。根據GMP的要求，過濾器不得有泄漏，這需要通過確認和定（dìng）期執行ISO14644-3中（zhōng）的（de）泄漏測試，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（yuè）進行泄漏測試，C/D級則為12個月。FDA無菌指南要（yào）求進行（háng）定期檢查。附錄1的要求在（zài）這裏也適用。泄漏是可（kě）以修補的，但（dàn）修補的麵積不能超過（guò）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，廣州靈潔淨化高效（xiào）過濾器並不隻（zhī）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（guò）濾器上下遊壓差升高，則送（sòng）排風係統的能量需求會增加，這樣才能維持必須的（de）換氣次數。這樣的過（guò）濾器上下遊壓差可能會增加通風（fēng）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（lǜ）器---通常是像F7和F9過（guò）濾器（qì）（EN779）這樣的精（jīng）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可（kě）以說最長使（shǐ）用期限直接取決（jué）於上下遊壓（yā）差。隻有在上下遊壓差達（dá）到一定數值影響到通（tōng）風（fēng）係統的性能，或者是能（néng）量（liàng）需求超過過濾器更換成本時（shí），過濾器（qì）更（gèng）換才有意義。但是，過濾器必須能（néng）通過泄漏測試（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值，這（zhè）都隻是根據經驗得來（lái）的。

靈潔高效過濾器更換問（wèn）題

谘（zī）詢內容：老師您好，小容量（liàng）注射劑車間（jiān）空調係（xì）統（tǒng）的高效過（guò）濾（lǜ）器必須（xū）定期更換嗎？如不定期更換，隻在空調驗證時更換（huàn）風量不合格房間高（gāo）效（xiào）和（hé）撿漏不（bú）合格高（gāo）效可（kě）以嗎？

CFDA審核查驗中心回（huí）複：你好，更換高效過濾器根據空（kōng）調驗證參考：時風量和撿漏是必須的，但同時也應（yīng）製定出具體高效過濾器最長使用周期，故還是（shì）應該有定期的概（gài）念。同時必須定（dìng）期進行過濾器完（wán）整性測試。

製藥（yào）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（gāo）效過濾器（qì）檢漏是否可以使用 塵埃（āi）粒子計數器 掃（sǎo）描檢（jiǎn）漏，如果可以（yǐ），那麽判斷無泄漏的標準是多少。

CFDA審核查驗中心回複：靈潔高效（xiào）過濾器檢漏一般在非關（guān）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（shǐ）用塵埃（āi）粒子計數器掃（sǎo）描檢漏