寧夏製藥廠高效過濾器

關於高效（xiào）過濾器的更換周期方麵的問題，很多潔淨（jìng）室用戶都很關心（xīn），畢竟高效過濾器決定著（zhe）潔（jié）淨室的潔淨度能否達到標準，就在前方国产乱子伦一区二区三区也整（zhěng）理過（guò）相（xiàng）關方（fāng）麵的問題：高效過濾器的更（gèng）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（zhì）藥行業（yè），高（gāo）效過濾器（qì）（HEPA）用於生產空間空（kōng）氣的處理和過濾的終端過濾器。無菌生產要求強製使用高效過濾器，而固體和半（bàn）固體劑型的生產有時也會使用。H13至H14（DIN1822）是高（gāo）效過濾（lǜ）器的（de）兩種，後者截留率為99.995%。但多久必（bì）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（gèng）換？

国产乱子伦一区二区三区經常看到（dào）在（zài）公司內部（bù）文件中，要求每年更換過濾器，而不管檢測結果如何。這是否合理？在相關的GMP指南中（zhōng）並沒有高效（xiào）過濾器（qì）可（kě）以使用（yòng）期限的具體數值。根據GMP的要（yào）求，過濾（lǜ）器（qì）不得有泄漏，這需要通（tōng）過確認和定（dìng）期執行ISO14644-3中（zhōng）的泄漏（lòu）測試，無菌車間來說這是（shì）必須的。根據附錄1（PIC/S PI032-2）的技術詮釋，A/B級每6個月進行泄漏測試，C/D級則為12個月。FDA無菌指南要求進行定期檢查（chá）。附錄1的要（yào）求在這裏（lǐ）也適用。泄漏是可以（yǐ）修補（bǔ）的（de），但修補的麵（miàn）積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（rán），廣州靈潔淨化高（gāo）效過濾器並不隻有完整性一件事情（qíng）。過濾（lǜ）器（層）的（de）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，則送排風係統的能量需（xū）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（shàng）下遊壓（yā）差可能會增加通風係統的性能限製。為了保護高效過濾器，就要使（shǐ）用前端過濾器---通（tōng）常是像F7和F9過濾器（EN779）這樣的精細過濾器。這些過濾器必須（xū）定期更換以保護（hù）高效過（guò）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，国产乱子伦一区二区三区可以說最長使用（yòng）期限直接取決（jué）於上下遊壓差。隻（zhī）有在上下遊壓差達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（huàn）成本時，過濾（lǜ）器更換（huàn）才（cái）有意義。但是，過濾器必須能通過泄漏測試（如上所（suǒ）述）。事實上，很多公司並不會使用一個過濾器（qì）超過8年。正如前述，並沒有法規規定這樣的值，這（zhè）都隻是根據經驗得來的。

靈潔高效過濾器更（gèng）換問（wèn）題

谘詢（xún）內容：老師您好，小容量注射劑車間空調（diào）係統的高效過（guò）濾器必須定期更換嗎？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（hé）撿漏不（bú）合格（gé）高效可以嗎？

CFDA審核查驗中心回複：你好，更換高（gāo）效過濾器根據空調驗（yàn）證參考：時風量（liàng）和撿（jiǎn）漏是必須的，但同時也應製定（dìng）出（chū）具體高效過濾器最（zuì）長使用周期（qī），故還是應該有定期的概念。同時必須（xū）定期進（jìn）行過濾器完（wán）整性測試。

製藥廠高效過濾器（qì）一般多久更換？

潔淨區A級高效過濾器檢漏

谘詢內容：潔淨（jìng）區A級高效過濾器檢漏是否（fǒu）可以使用 塵埃粒子計數（shù）器 掃描檢漏，如（rú）果可以，那麽判（pàn）斷無泄漏（lòu）的標準是多少。

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（qū）域可以使用塵埃粒子計數器（qì），但A級潔淨（jìng）區高效過濾器不推薦使（shǐ）用塵埃粒子計數器掃（sǎo）描檢漏