龍岩製藥廠高（gāo）效過（guò）濾器

關於高效過濾器的更換周期方麵的問（wèn）題，很多潔淨（jìng）室用戶都（dōu）很（hěn）關心，畢竟高效過濾器（qì）決定著潔淨室（shì）的潔（jié）淨度能（néng）否（fǒu）達到標準，就在前方91小视频也整理過相關方（fāng）麵的（de）問題：高效過（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（háng）業，高（gāo）效過濾（lǜ）器（HEPA）用於（yú）生產空間空（kōng）氣的處理和過濾的終（zhōng）端過濾器。無菌生產要求強製使用高效過濾器，而固體和（hé）半固體劑型的生產有時也會使用。H13至H14（DIN1822）是（shì）高效過（guò）濾器的兩種，後者截留（liú）率為99.995%。但多久必須（xū）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）廠高效過濾器一般多（duō）久更換？

91小视频（men）經常看到（dào）在公司內部文件中，要求每年更換過濾器，而不管檢（jiǎn）測結果如何。這是否合理？在（zài）相關的GMP指南中並（bìng）沒（méi）有高效過濾器（qì）可以使（shǐ）用期限的（de）具體數值。根據GMP的要求（qiú），過（guò）濾器不得有泄漏，這（zhè）需要通（tōng）過確認和定期執行ISO14644-3中的泄漏測試，無菌（jun1）車間來說這是必須（xū）的。根據附錄1（PIC/S PI032-2）的（de）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無菌指南要求進行定期檢查。附錄1的要求在這裏也適用。泄漏是可（kě）以修補的，但修補的（de）麵積不能超（chāo）過（guò）單個過濾（lǜ）器麵（miàn）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（xìng）一件事情。過濾器（層）的負載以及上下（xià）遊壓差也很重要。如果過濾器上下遊壓差升高，則送排風係統的能量需求（qiú）會增加，這（zhè）樣才能維（wéi）持（chí）必須的換氣次數。這樣（yàng）的過濾器（qì）上下遊壓差可能會增加通風係統的性能限製。為（wéi）了保護高效過濾器，就要使用前端過濾器---通常是像F7和F9過濾器（EN779）這樣的精細過濾器。這些（xiē）過（guò）濾器必須定（dìng）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（dù）來看，91小视频可以說最（zuì）長使用（yòng）期（qī）限（xiàn）直接取決於上下遊壓差。隻有在上下遊壓差達到一定數值影響到通風係統的性能，或者（zhě）是能量需求超過過濾器更換成本時，過濾器（qì）更換才有意義。但是（shì），過濾器必須能（néng）通（tōng）過泄漏測試（如上所述）。事（shì）實上，很多公司並不會使用一個過濾（lǜ）器超過8年。正如前述（shù），並沒有（yǒu）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（nèi）容：老師您好，小容量注射劑車（chē）間空調係統的（de）高效過（guò）濾（lǜ）器必須（xū）定期更換嗎？如（rú）不定期（qī）更換，隻在空調驗證（zhèng）時更換風量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（huí）複：你好，更換（huàn）高（gāo）效過濾器根據空調驗證參考：時風量和撿漏是必須的，但同時也應製定出具體高效（xiào）過（guò）濾器最長使用周期，故還是應該有定期的概念。同時必須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（jiǔ）更換？

潔淨（jìng）區A級（jí）高效過濾器檢漏

谘詢內（nèi）容：潔淨區A級高效過濾器（qì）檢漏是否可以使用 塵埃粒子計數器 掃描檢漏，如（rú）果（guǒ）可以，那（nà）麽判斷無泄漏的（de）標準是多少。

CFDA審核查（chá）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（jié）淨（jìng）區高（gāo）效過濾器不推薦使（shǐ）用塵埃粒子計數（shù）器掃描檢漏