開封製藥廠高效過濾器

關於高效過濾器的更換周期方麵的問題，很多潔淨室用戶都很關心，畢（bì）竟高效過濾器決定（dìng）著潔淨室的潔淨（jìng）度能否達到標準，就在前方91小视频也整理過相（xiàng）關方麵的問題：高（gāo）效過濾器的更換（huàn）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（yòng）於生產空間空氣的處理和（hé）過濾的終端過濾器。無菌生產要求強製使用高效過濾器，而固體和半（bàn）固（gù）體（tǐ）劑型的生產有時（shí）也會使（shǐ）用。H13至H14（DIN1822）是高效過濾器的兩種，後者（zhě）截（jié）留率為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（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（gāo）效過濾器一般多久更換？

91小视频經常（cháng）看到（dào）在公司內部文件中，要求每年更換過濾器，而不（bú）管檢測結果如何。這是否（fǒu）合理？在相關的GMP指（zhǐ）南（nán）中並沒有高效過濾器可（kě）以使用期限的具體數值。根據（jù）GMP的要求，過濾器（qì）不（bú）得有泄漏，這需要通過確（què）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）的技術詮釋，A/B級每6個月進行泄漏測試，C/D級則（zé）為12個月。FDA無菌指南要求進行定期檢查。附錄1的要求在這裏也適用。泄漏是可以修補的，但修補的麵積（jī）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（jié）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（zǎi）以及上（shàng）下遊壓差也很重要。如果過濾器上（shàng）下遊壓（yā）差（chà）升高，則送排風係統的能量（liàng）需求會增加，這樣才能維持必須的換氣次（cì）數。這樣的過濾器上下遊（yóu）壓差可能會增加通風係統的性能限製。為了保（bǎo）護高效過濾器，就要使用前端過濾器---通常是（shì）像F7和F9過濾器（EN779）這（zhè）樣的精細（xì）過濾器。這些過濾（lǜ）器必須定期更換以保（bǎo）護高效過濾器（qì）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小视频可以說最長使用期限（xiàn）直接取決於上下遊壓差。隻有在上下遊壓差達（dá）到一定數值影響到通風係統的性能，或者是能量需求超過過濾器更換成本時，過濾器（qì）更換才有意（yì）義。但是，過濾器必（bì）須能通過泄漏測（cè）試（如上（shàng）所述）。事實（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（guī）定這樣的值，這都隻是根據經驗得來（lái）的。

靈潔高效過濾器更換問題

谘詢內容：老師（shī）您（nín）好，小容量注射劑車間空調係（xì）統的高效過濾器（qì）必須定期（qī）更換（huàn）嗎？如不定期更換，隻在空調驗證時更換風量不合格房間高效和撿漏不合格高效可以嗎？

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

製（zhì）藥廠高（gāo）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（xún）內容：潔（jié）淨區A級高效過濾器檢漏是否可以使用 塵埃（āi）粒子計數器 掃（sǎo）描檢漏，如果可以，那麽判斷（duàn）無泄漏的標準是多少。

CFDA審（shěn）核查驗（yàn）中心回複：靈潔高效過濾器檢漏（lòu）一般在非關（guān）鍵區（qū）域可以使用塵埃粒子計數器，但（dàn）A級潔（jié）淨區高效過濾器不推薦使用塵埃（āi）粒子（zǐ）計數器掃描檢漏