婁底製（zhì）藥（yào）廠高效過濾器

關於高效過濾器的更換周期方麵（miàn）的問題，很（hěn）多潔淨室用戶（hù）都很關心，畢竟高效過濾器決定（dìng）著潔淨室（shì）的潔淨度能否達到標準（zhǔn），就在前（qián）方草莓秋葵菠萝蜜黄瓜榴莲视频也整理過相關方麵的問題：高效過濾器（qì）的更（gèng）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（yào）行業，高效過（guò）濾器（HEPA）用於生產（chǎn）空（kōng）間空氣的處理（lǐ）和過濾的終端過濾器（qì）。無菌生產要求強（qiáng）製使用（yòng）高效過濾器，而固體和半固體劑型的生產（chǎn）有時（shí）也會使用。H13至（zhì）H14（DIN1822）是高（gāo）效過（guò）濾（lǜ）器的兩種，後者截留率為（wéi）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（chǎng）高效過濾器一般多久（jiǔ）更換？

草莓秋葵菠萝蜜黄瓜榴莲视频（men）經常看到在公司內部文件中，要求每年更換過濾器，而不管檢測結果如何。這（zhè）是否合理？在相關的GMP指南中並沒有高（gāo）效過濾器可（kě）以使用期限的具體數值。根（gēn）據GMP的要求，過濾器不得有泄（xiè）漏，這需要通過確（què）認和定期（qī）執行ISO14644-3中的泄漏測試，無菌車間來說這是必須的（de）。根據附錄1（PIC/S PI032-2）的技術詮釋，A/B級每6個月（yuè）進行（háng）泄漏測（cè）試，C/D級則為12個月。FDA無菌指南（nán）要求進行定期檢查。附錄1的要求在這裏也適用。泄漏是可以修補（bǔ）的，但修補的麵（miàn）積不能超過單個過濾器麵（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一件事（shì）情。過濾器（層）的（de）負載以及上下遊壓差也很重要。如果過濾器上下遊壓差升高，則送排風係統的能量需求會增加，這樣才能維持（chí）必（bì）須的換氣次數（shù）。這樣（yàng）的過（guò）濾器上下遊（yóu）壓差可能會增加通風係統的性能限製。為了保護高效過濾器，就要使用前端過濾器---通常是像F7和（hé）F9過濾器（EN779）這樣的精細過濾器。這些（xiē）過濾器必須定期更換以保護高（gāo）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以說最長使用期限直接取決於上下遊（yóu）壓差。隻有在上下遊壓差（chà）達到一定數值影響（xiǎng）到通風係統的性（xìng）能，或者是能（néng）量需求超過過濾器更換成本時（shí），過濾器更（gèng）換（huàn）才（cái）有意義。但是，過濾器必須能通（tōng）過泄漏測試（如上所述）。事實上，很多（duō）公司並不會使用一個過濾器超過8年。正如（rú）前述，並沒有法規規定這（zhè）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（liàng）注射劑車間空調（diào）係統的高效過濾器必須定（dìng）期更換（huàn）嗎？如不定期更換，隻在空調驗證時更換風（fēng）量不合格房間高（gāo）效和（hé）撿漏不合格高效可（kě）以嗎？

CFDA審核查驗中心回複：你好，更換高效過濾器根據（jù）空調驗證參（cān）考：時風量和撿漏是必（bì）須的，但同時也（yě）應製定出具體高效過濾器最長使用周期（qī），故還是應該有定期的概念。同時（shí）必須定期進行過濾器完整性測試。

製藥廠高效過（guò）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（jìng）區A級高效過濾器檢（jiǎn）漏是否可以使用 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（shì）多少。

CFDA審核查驗中心回複：靈潔高效過濾器檢漏一（yī）般在非關鍵區域可以使用塵埃粒子計數器，但（dàn）A級潔淨區高效過濾器不推薦（jiàn）使用塵埃粒子計數器掃（sǎo）描（miáo）檢（jiǎn）漏（lòu）