荊州（zhōu）製藥（yào）廠高效（xiào）過濾器

關於高（gāo）效（xiào）過濾器的更換周期方麵的問（wèn）題，很多潔淨室用戶都很關心，畢竟高效過濾器決定著潔淨（jìng）室（shì）的潔淨（jìng）度能否（fǒu）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（xiàng）關方（fāng）麵的（de）問題：高效（xiào）過（guò）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）間空氣的處理和過濾的終（zhōng）端過濾器。無菌（jun1）生產要求強製使用高效過濾器，而固體和半固體劑型的生產有時也會使用。H13至H14（DIN1822）是高效過濾器的（de）兩種，後者截留率（lǜ）為99.995%。但多（duō）久必須更換一（yī）次呢（ne）？

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（zhì）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（gōng）司內部文件中，要求每年更（gèng）換過濾器，而不管檢測結果如何（hé）。這是否合理？在相關（guān）的GMP指（zhǐ）南中並（bìng）沒（méi）有高效過濾器可以使用期限的具體數值。根（gēn）據GMP的要求，過（guò）濾器不得有（yǒu）泄漏，這需要通（tōng）過確認（rèn）和定期執行（háng）ISO14644-3中的泄漏測試，無菌車間來說這是必須的。根據附錄1（PIC/S PI032-2）的技（jì）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檢（jiǎn）查。附錄1的要求在這裏也（yě）適用。泄漏是可（kě）以修（xiū）補的，但修補的麵（miàn）積（jī）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，廣州靈潔淨（jìng）化高效過濾器並不隻有（yǒu）完整性（xìng）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（qì）上下遊壓差（chà）升高，則（zé）送排風係統的能量需求會（huì）增加，這樣才能維持（chí）必須的換氣次數。這樣的過濾器上下遊壓差（chà）可能會增加通風係統的性能限製。為了（le）保護高效（xiào）過濾器，就要使用前端過濾器---通常是像F7和F9過（guò）濾器（EN779）這樣的精細（xì）過濾器（qì）。這些過濾器必須定期更換以保護高效過濾器（qì）避免堵（dǔ）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（dù）來看，草莓秋葵菠萝蜜黄瓜榴莲视频可以說最（zuì）長（zhǎng）使用期限直接取（qǔ）決於上下遊壓差。隻有在上下遊壓差（chà）達到一定數值影響到通風係統的性能，或者是能（néng）量需求超過過濾器（qì）更換成本時，過（guò）濾器更換才有意義（yì）。但是（shì），過濾器必須能通過泄漏測試（如上所述）。事（shì）實上，很多公司並不會使用（yòng）一個過濾器超過（guò）8年（nián）。正如前述，並沒有法規規定這樣的值，這都隻是根據經驗得來的。

靈潔高效過濾器更換問題

谘詢內容：老師您好，小容量注射劑車間（jiān）空調係統的高效（xiào）過濾器必須定（dìng）期（qī）更換嗎？如不定期更換，隻在（zài）空調驗（yàn）證時更換風量不（bú）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，但同時也應製定出具體高（gāo）效過濾器（qì）最長使用周期，故（gù）還（hái）是應該有（yǒu）定期的概念。同時必須（xū）定期進行過濾器完整性測試（shì）。

製藥廠高效過濾器一般多久更（gèng）換？

潔淨區A級高效過濾器檢（jiǎn）漏

谘詢內容：潔淨區A級高效過濾（lǜ）器（qì）檢漏是否可以使用 塵埃粒子計數（shù）器 掃描檢漏，如果（guǒ）可以，那麽判斷無泄漏的標準是多少。

CFDA審（shěn）核（hé）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塵埃粒子計數器，但A級潔淨區高效過濾（lǜ）器（qì）不推（tuī）薦使用塵埃粒子計數（shù）器掃描檢漏