鷹潭製藥廠高效（xiào）過濾器

關於高效過濾器（qì）的更換周期方麵的問題，很多潔淨室用（yòng）戶都很關心，畢竟高效過濾器決定（dìng）著潔淨室的潔淨度（dù）能否達到標準，就在前方（fāng）91小视频也整理（lǐ）過相關方麵（miàn）的問題：高效（xiào）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（xiào）過濾器（HEPA）用於生產空間空氣的處理和過（guò）濾的終端（duān）過濾器。無（wú）菌生產要求強製使用高效（xiào）過濾器（qì），而固體和（hé）半固體劑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（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（nián）更（gèng）換過濾器，而不管檢測結果如何。這是否合理？在相關的GMP指（zhǐ）南中並沒有高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，無菌車間來說這是必須的。根據附錄1（PIC/S PI032-2）的技（jì）術（shù）詮釋，A/B級每（měi）6個月進行泄漏測（cè）試，C/D級則（zé）為（wéi）12個月。FDA無（wú）菌指南要求（qiú）進行（háng）定期檢查。附錄1的要求在這（zhè）裏也適用。泄漏是可以修補的，但修（xiū）補的麵積不能（néng）超過單個過濾器麵積的（de）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（guò）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（yóu）壓差也很重要。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（zhè）樣才能維持必須的換氣次數。這樣的過濾器上下遊壓（yā）差（chà）可能（néng）會增加通風係統的（de）性（xìng）能限製。為了（le）保護高（gāo）效過濾（lǜ）器（qì），就要使用前端過濾器---通常是像F7和F9過濾器（EN779）這樣的精細過濾器。這（zhè）些（xiē）過（guò）濾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）踐角度來看，91小视频可以說（shuō）最長使用（yòng）期限直接取決於上（shàng）下遊壓差。隻有在上下（xià）遊壓差達到一定數值影響到通風（fēng）係統的性能，或者是（shì）能量需求超過過濾（lǜ）器更換成本時，過濾器更換才有意義。但是（shì），過濾器必須能通過泄漏測試（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（guī）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（róng）量注射劑車間空調係統的高效過濾器必須定期更換嗎？如不定期更換（huàn），隻在空調（diào）驗證時更（gèng）換風量不合格房間高效（xiào）和撿漏不合格高效可以嗎？

CFDA審核查驗中心回複：你好，更換高效（xiào）過濾器根據空調驗（yàn）證參考：時風量和撿漏是必須的，但同時也應（yīng）製定出（chū）具體高（gāo）效（xiào）過濾器最長使用周（zhōu）期，故還是（shì）應該有定期的概念。同（tóng）時必須定期進行過濾（lǜ）器完整性測試。

製藥廠高效過濾器一般多久更換？

潔淨區（qū）A級高效過濾器檢漏

谘詢內容：潔淨區A級高效過濾（lǜ）器（qì）檢漏（lòu）是否可以（yǐ）使用 塵埃粒子計數器 掃描檢漏，如果可以，那麽判斷無泄漏的標準是多少。

CFDA審核查（chá）驗中（zhōng）心回複：靈潔高效過濾器（qì）檢漏一般在非關鍵區（qū）域可以使用塵埃粒子計數器，但A級潔淨區高（gāo）效過濾（lǜ）器不推薦使用塵埃粒子（zǐ）計數（shù）器掃描檢漏