日喀則製藥廠高效（xiào）過濾器

關於高效過濾（lǜ）器的更換周期方麵的問題，很多潔淨室用（yòng）戶都很關心，畢（bì）竟高效過濾器決定著潔淨室的潔淨度能（néng）否達到（dào）標準，就在前方嫩草影院也整理過相（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（zài）製藥行業（yè），高（gāo）效過濾器（HEPA）用於生產空間空氣的處理（lǐ）和過濾的（de）終端過濾器。無菌生產要求強（qiáng）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（zhě）截留率為99.995%。但多久（jiǔ）必（bì）須更換一次（cì）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（cān）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（guò）濾器一般多久更（gèng）換？

嫩草影院經常看到（dào）在公司內部文件中，要求每年更（gèng）換過濾器，而不管檢測結果（guǒ）如何。這是否合理（lǐ）？在相關的GMP指南中並沒有（yǒu）高效過濾器可（kě）以使用期限的具體數值。根（gēn）據GMP的要求，過濾器不（bú）得有泄漏，這需要通過確認和定（dìng）期執行ISO14644-3中的泄漏測試，無菌車間來說這是（shì）必須的。根據附錄1（PIC/S PI032-2）的技術（shù）詮釋，A/B級每6個月進行泄（xiè）漏測試，C/D級則（zé）為12個月。FDA無（wú）菌指南要求進行定期檢查。附錄1的要求在（zài）這裏（lǐ）也適用。泄（xiè）漏是可以修補的，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。過濾器（層）的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（zé）送排風係統的能量需求（qiú）會增加，這樣才能維持必須（xū）的換氣次數。這樣（yàng）的過濾器上下遊壓差可能會（huì）增加通風係統（tǒng）的（de）性能限（xiàn）製。為（wéi）了保護高效過濾器，就要（yào）使用前端過濾器---通常是（shì）像F7和F9過濾器（EN779）這樣的精細過濾器。這些過濾器必須定期更換（huàn）以保護高效過濾（lǜ）器避免堵塞（sāi）

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）踐角度（dù）來看，嫩草影院可以說最長使用期限直接取決於上下遊壓差。隻有在上下遊（yóu）壓（yā）差達到一定數（shù）值影響到通（tōng）風係統的性能，或者是能量（liàng）需求超過過濾器更換成本時，過濾器更換才有意義。但是，過濾（lǜ）器必須能通（tōng）過泄漏測試（如上所述）。事實上，很多公司並不會使用一個過濾（lǜ）器超過8年。正如前述，並沒有法規規定這（zhè）樣（yàng）的值，這都（dōu）隻是根據經驗得來的（de）。

靈潔高效過濾器更換問題

谘詢內容：老（lǎo）師您好（hǎo），小容量注射劑車間空調係統的高效過濾（lǜ）器必須（xū）定期（qī）更換嗎？如（rú）不定期更換，隻（zhī）在空調驗證時更換風量不合格房間（jiān）高效和撿漏不合格高效可以嗎？

CFDA審（shěn）核查驗中心回複：你好，更換高效過濾器（qì）根據空調驗證參考：時風量和撿漏是必須的，但同時也應製定（dìng）出具體高（gāo）效（xiào）過濾器最（zuì）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（qì）完整性測試。

製藥（yào）廠高（gāo）效過（guò）濾（lǜ）器一（yī）般多久更換？

潔淨區（qū）A級高效過濾器檢漏

谘詢內容：潔淨區（qū）A級高效過（guò）濾器檢（jiǎn）漏是否可以使用（yòng） 塵埃粒子計數器 掃描檢漏，如果可以，那麽判斷無泄漏的（de）標準是（shì）多少。

CFDA審核查驗中（zhōng）心回複：靈潔高效過（guò）濾器檢漏一般在非關鍵區域可以使（shǐ）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（chén）埃粒子計數器掃描檢漏