邵陽製（zhì）藥廠高效（xiào）過濾器

關於高（gāo）效過濾器（qì）的更換周期方麵的問題，很多（duō）潔淨（jìng）室用戶都（dōu）很關心（xīn），畢竟高效（xiào）過濾器決定著潔淨室的潔淨度能否達到標準，就在（zài）前（qián）方91小视频也整理過相（xiàng）關方（fāng）麵的問題：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，高效過濾器（HEPA）用於生產空間空氣的處理和過濾的終端過濾器。無菌生產要求強（qiáng）製使用高效過濾器，而固（gù）體和半固體劑型的生產（chǎn）有時也會使用。H13至H14（DIN1822）是高效過濾器的兩種，後者截留率（lǜ）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多久更換？

91小视频經常看到在公司內部（bù）文件中，要求每年更換過濾器，而不管（guǎn）檢測結果如何。這是（shì）否合理？在（zài）相關的GMP指南中並沒有高（gāo）效過濾器可以使用期限的具體數值。根（gēn）據GMP的要求，過濾器（qì）不得有泄漏（lòu），這需要通過確認和（hé）定期執行ISO14644-3中的泄（xiè）漏測試，無菌車間來（lái）說這是必須的。根據附錄1（PIC/S PI032-2）的技術詮釋，A/B級每6個月進行（háng）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（de）要求在這裏也適用。泄漏（lòu）是可以修補（bǔ）的，但修（xiū）補的麵積不（bú）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，廣州靈潔淨化（huà）高效過濾器並不隻有（yǒu）完整性一（yī）件事情（qíng）。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（shēng）高，則送排風係統的能量需求會（huì）增加（jiā），這樣才能（néng）維持必須（xū）的換氣（qì）次數。這樣的過濾器上下遊壓差可能會增加通風係（xì）統的性能限製。為了保護（hù）高效（xiào）過濾（lǜ）器，就要使用前（qián）端過濾器（qì）---通（tōng）常是像F7和F9過濾器（EN779）這樣的精細過濾器。這（zhè）些過濾器必須定期更換（huàn）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（jiàn）角度來看，91小视频可以說最長使用期限直接取決於上下遊壓（yā）差。隻有在上下遊壓差達到一（yī）定數值（zhí）影（yǐng）響到通風係統的性能，或者是能量需求超（chāo）過過濾器（qì）更換成本時，過濾器更換才有意義。但（dàn）是，過濾器必須能通過泄漏測試（如上所述）。事（shì）實（shí）上，很多（duō）公司並不會使用一個（gè）過濾器超過（guò）8年。正如前述，並沒有法規規定這（zhè）樣的值，這（zhè）都隻是根（gēn）據經驗得來的。

靈潔高效過濾器（qì）更換問題

谘詢內（nèi）容：老師您（nín）好，小容量注射劑車間（jiān）空調係統的高效（xiào）過濾器必須定期更（gèng）換嗎？如不定（dìng）期更換，隻在（zài）空調驗證時更換風（fēng）量（liàng）不合格房間高效和撿漏不合（hé）格高效可（kě）以嗎？

CFDA審核查（chá）驗中（zhōng）心回複：你好，更換高效（xiào）過濾器根據空調驗（yàn）證（zhèng）參考：時風量（liàng）和（hé）撿漏（lòu）是必須的，但同時也應製定出具體高效過濾器最長使用周期，故還是應該有定期的概念。同時必須定期（qī）進行過濾器完整性測試。

製（zhì）藥（yào）廠高效（xiào）過濾器一（yī）般多久更換？

潔淨區A級高效過濾器檢漏

谘詢內容：潔（jié）淨區（qū）A級高效過濾器檢漏（lòu）是否可以（yǐ）使用（yòng） 塵埃（āi）粒子計數器 掃描檢漏，如果可以（yǐ），那麽判斷無泄漏（lòu）的標（biāo）準是多少（shǎo）。

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塵埃粒子計數器，但A級潔淨區高效過濾器不推薦使用塵埃（āi）粒子計數器掃（sǎo）描檢（jiǎn）漏（lòu）