株洲製藥廠（chǎng）高效過濾器

關於高效過（guò）濾器的更換周期方麵的（de）問題，很多潔淨室（shì）用戶都很關心，畢竟高效過濾器決（jué）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的問（wèn）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）用於生產空間空氣的（de）處理和過濾的終端過濾器。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（zhì）H14（DIN1822）是高效過濾（lǜ）器的兩種（zhǒng），後者截留率為99.995%。但多久必須更（gèng）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般（bān）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（měi）年更換過濾器，而（ér）不管檢測結果如何。這是（shì）否（fǒu）合理？在相（xiàng）關的GMP指南中並沒有高（gāo）效過濾器可以使用期限的具（jù）體數值（zhí）。根據GMP的要求，過（guò）濾器不得有泄（xiè）漏，這需（xū）要（yào）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須的。根據（jù）附錄1（PIC/S PI032-2）的技術詮釋，A/B級每（měi）6個月進行泄漏測試，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的要求在這裏（lǐ）也適用。泄漏是（shì）可以修補的，但修補的麵積不能（néng）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，廣州靈潔淨化高效過濾器並不隻有完整性一件事情。過濾（lǜ）器（層）的負載以及上下遊壓（yā）差也很重要。如果過（guò）濾器上下遊壓差升高，則送排風係統的能量需求會增加，這樣（yàng）才能維（wéi）持必須的（de）換氣次數。這樣的過濾器上下遊壓差可能會（huì）增（zēng）加通風（fēng）係統的（de）性能限製。為了（le）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（qì）（EN779）這樣（yàng）的精細過濾器。這些過濾（lǜ）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（shí）踐（jiàn）角度來看，草莓秋葵菠萝蜜黄瓜榴莲视频（men）可以說最長使用期限直接取決於上下遊壓差。隻有（yǒu）在上下遊壓差達到一（yī）定數值影響（xiǎng）到（dào）通風係統的（de）性能，或者是能量需求超過過濾器更換（huàn）成本時，過（guò）濾器（qì）更換才有意義。但是，過濾器必須（xū）能通過泄漏測試（如上所述）。事（shì）實上，很多公司並不會使用一個過濾器超過8年。正如前述，並沒有法規規定這樣的值，這都（dōu）隻是根據經驗得（dé）來的。

靈潔高效過濾器更換（huàn）問題

谘詢（xún）內容：老師您好，小容量注射劑車（chē）間空調係統的高效過濾器必（bì）須定期更（gèng）換嗎？如（rú）不定期（qī）更換，隻在空（kōng）調驗證時更換（huàn）風量不合格房間高效和撿漏不合格高（gāo）效可（kě）以嗎？

CFDA審核查驗中心回複：你好，更換高（gāo）效過濾器根據空調驗證（zhèng）參考：時風量和撿漏是必須的，但同（tóng）時也應製定出具體高效過濾器最（zuì）長使用周期，故還是應該有定期（qī）的概念。同（tóng）時必須定期進行過濾器完整性測試。

製藥（yào）廠高效過濾器一般多（duō）久更換（huàn）？

潔淨區A級高效過濾器檢漏

谘詢（xún）內容：潔淨區A級高效過濾器檢漏是否可以使用（yòng） 塵埃粒子計數器 掃描檢漏，如果可以，那麽判斷（duàn）無泄漏的標準是多少。

CFDA審核（hé）查驗中心（xīn）回複：靈潔高（gāo）效過濾器檢（jiǎn）漏一（yī）般在非關鍵區域可以使用塵埃粒（lì）子計數（shù）器，但A級潔淨區高效過濾器不推（tuī）薦（jiàn）使用塵埃粒子（zǐ）計數器掃描檢（jiǎn）漏