宜賓製藥廠高效過濾器

關於高效過濾器的更換周期方麵的（de）問題，很（hěn）多潔淨室用戶都很關心，畢（bì）竟高效（xiào）過濾器決定著潔淨室的潔淨度能否達到標準，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（wèn）題：高效過濾（lǜ）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（qì）的處理和過濾的終（zhōng）端過濾器。無菌生產要求強製使用（yòng）高（gāo）效過濾器，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（xiào）過濾（lǜ）器的兩種，後者截留率為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（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（dào）在公司內部文件（jiàn）中，要求每年更換過濾器，而不管檢測結果如何（hé）。這是否合理？在（zài）相關（guān）的GMP指南中並（bìng）沒有高效過濾器可以使用期限的（de）具體數值。根據（jù）GMP的要求，過濾器不得有泄漏，這需要通過確認和定期執行ISO14644-3中的泄漏測試，無菌車間來說這是必（bì）須的。根據附錄1（PIC/S PI032-2）的（de）技術詮釋，A/B級每6個月進（jìn）行（háng）泄漏（lòu）測試，C/D級則為（wéi）12個月（yuè）。FDA無菌指南要求進行定期檢查。附（fù）錄1的要求在這（zhè）裏也適用。泄漏是可以修補的，但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，廣州靈潔淨化高效過濾器並不隻有完整性一件事情。過濾器（層）的負載以及（jí）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（tǒng）的能量需求會增加，這（zhè）樣才能維持（chí）必須的換氣次數。這樣的過濾器上下遊壓差可能（néng）會增加通風係統的性能限製。為了保護高效過（guò）濾器，就要使（shǐ）用前端過濾器---通常是像F7和F9過濾器（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（bì）免堵塞（sāi）

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（yǐ）說最（zuì）長使用期限直（zhí）接取決於上下遊壓差（chà）。隻有在上下（xià）遊壓差達（dá）到一（yī）定數值影響到通風係統的性能，或（huò）者是能量需（xū）求超（chāo）過過濾（lǜ）器更換成本時，過濾器更換（huàn）才有意義。但是，過濾器必須能通過泄漏測（cè）試（shì）（如上所述）。事實上，很多公司並不會使用一個過（guò）濾器超過8年。正如前述，並沒（méi）有法規規定這樣（yàng）的值，這都隻是（shì）根據經驗得來的。

靈（líng）潔高效過濾器更換問題

谘詢內容：老師您好（hǎo），小容量注射劑車間空調係統的高效過濾器必須定期更換嗎？如不定期（qī）更換，隻在空（kōng）調驗證時更換風量（liàng）不合格房間高效和撿漏不合格高效可以嗎？

CFDA審核查驗中心回複：你好，更換（huàn）高效過濾器根據空（kōng）調驗證參考（kǎo）：時風量和撿（jiǎn）漏是必須的，但同時也（yě）應（yīng）製（zhì）定出具體高（gāo）效過濾（lǜ）器最長使（shǐ）用周期（qī），故還是應該有定期的概念。同時必須定期（qī）進行過濾器完整性測試。

製藥廠（chǎng）高效過濾器一般（bān）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（lòu）是否可以使用 塵埃粒子計數器 掃描（miáo）檢漏，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：靈潔高效過濾器檢漏一般在非關鍵區域可以使用（yòng）塵埃粒子計數器，但A級（jí）潔淨區高效過濾器不推薦使（shǐ）用（yòng）塵埃粒子計數器掃描檢（jiǎn）漏