東營製藥廠（chǎng）高效過濾器

關於高效過（guò）濾器的更換周期方麵的問題，很多潔淨室用戶都很關心，畢竟（jìng）高效過濾器決定著（zhe）潔淨室的潔淨度能（néng）否達到標準，就在前方91小视频也（yě）整理過相（xiàng）關方麵的問題：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（qì）的處理（lǐ）和（hé）過濾的終端過濾器（qì）。無菌生產（chǎn）要求強製使用高效過濾器，而固體和半固體劑（jì）型的生產有時也會使用。H13至H14（DIN1822）是高效過濾器的兩種，後者截留率為99.995%。但多（duō）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（gāo）效過濾器一般多久更換？

91小视频經（jīng）常看到（dào）在（zài）公司內部（bù）文件中，要求每年更換過濾器，而不管檢測結（jié）果（guǒ）如何。這是（shì）否合理？在相關的（de）GMP指南中並沒有高效過濾器可以使用期限的（de）具體數值。根據GMP的要（yào）求，過濾器不（bú）得有泄漏，這需要通過確認和定期執行ISO14644-3中的泄漏測試，無菌車間來說（shuō）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（yuè）。FDA無菌指南要求進行定期檢查。附錄1的要求在這（zhè）裏也適用。泄漏是可以修補（bǔ）的，但修（xiū）補的麵積（jī）不能超過單個（gè）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（jié）淨化高效過濾（lǜ）器並（bìng）不隻有完整性一件（jiàn）事情。過濾器（qì）（層）的負載以（yǐ）及上下遊壓差也（yě）很重要。如果過濾器上下遊壓差升高（gāo），則送排風係統的能量需求會增加，這樣才（cái）能維（wéi）持必須的換氣次數。這樣的過濾器上下遊壓差可（kě）能會增加通風係統的性能限（xiàn）製。為了保護高效過濾器，就要使（shǐ）用前端過濾器---通常是像F7和F9過濾器（qì）（EN779）這樣的精細過濾（lǜ）器。這些過濾器必須定期更換以保（bǎo）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.

從實踐角度來看，91小视频（men）可以說最長使用期（qī）限直接（jiē）取決於上下遊壓差。隻有在上下遊（yóu）壓差（chà）達到一定數值影響到（dào）通風係統的性能，或者是能量（liàng）需求超過過濾器更換（huàn）成本時，過濾器更換才有（yǒu）意義。但是，過濾器必（bì）須能通過泄漏測試（如上所述）。事（shì）實（shí）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，這都隻是根據經驗得來的。

靈潔高效過濾（lǜ）器更換問題

谘詢內容：老師您好，小容量注（zhù）射劑車間空調係統的高效過濾器必須定期更換（huàn）嗎（ma）？如不定期更換，隻在空調驗證時更換風量不合格房間（jiān）高（gāo）效和撿漏不合格高效可以嗎？

CFDA審核查驗中（zhōng）心回複：你好，更換高（gāo）效過濾器（qì）根據空調驗證參考：時風量和撿漏是必須的，但同時也應製（zhì）定出具體高效過濾器最長使用周（zhōu）期，故（gù）還是應該有定期的概念。同時必須定期進行過濾器（qì）完整性測試。

製藥（yào）廠高效過濾器一般多久更換？

潔淨區A級高效過濾器檢漏

谘詢內（nèi）容：潔淨區A級高效過濾（lǜ）器檢（jiǎn）漏是（shì）否可以使用 塵埃粒子計數（shù）器 掃描檢漏，如果可以，那麽判斷無泄漏的（de）標準（zhǔn）是多少。

CFDA審核查驗中心回複：靈潔高效過濾器檢（jiǎn）漏一（yī）般在（zài）非（fēi）關鍵區域可以使用（yòng）塵（chén）埃粒子計數（shù）器，但A級潔淨區高（gāo）效過濾器不推薦使用塵埃粒（lì）子計數器掃描檢漏