六安製藥廠高效過濾器

關於高（gāo）效過濾器的（de）更換周期（qī）方麵的問題，很多潔淨室用戶都很關心（xīn），畢竟高效過濾器決定著潔淨室的潔淨度能否達到標準，就在前方嫩草影院也整（zhěng）理過（guò）相關方麵的（de）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）用於生產空間空氣的處理（lǐ）和過濾（lǜ）的終端過濾器。無（wú）菌生產要求強製使用（yòng）高效過濾器，而固體和半固體劑型的生產（chǎn）有時也會使用。H13至H14（DIN1822）是高效過（guò）濾器的（de）兩種，後者截留率為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？

嫩草影院經（jīng）常看到（dào）在公司內部文件中（zhōng），要求每年（nián）更換過濾器，而不管檢測結果如何。這是否合（hé）理？在相關的GMP指南中並沒有高效過濾器（qì）可以使用期（qī）限的具體數值。根據GMP的要求，過濾器不得有泄（xiè）漏，這需要通過確認和定期（qī）執行ISO14644-3中的泄漏測試，無菌車間來說（shuō）這是（shì）必須的。根據附（fù）錄1（PIC/S PI032-2）的技（jì）術（shù）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。附錄1的要求在這裏（lǐ）也適用。泄漏是可以（yǐ）修補的，但修補的麵積不（bú）能超過單個過濾（lǜ）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（zhōu）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（yā）差升高，則送排風係統的能量需（xū）求會（huì）增加（jiā），這樣才（cái）能維持必須的換氣次數。這樣（yàng）的過濾器上下（xià）遊壓差可（kě）能會（huì）增（zēng）加通風係統的性能限製。為了（le）保護高（gāo）效過濾（lǜ）器，就要使用前端過濾器---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以（yǐ）保護高效過濾器避免（miǎn）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，嫩草影院可（kě）以說最長使用期限直接（jiē）取決於上下遊壓差。隻有在上下遊壓差達到一定數值（zhí）影（yǐng）響到通風係統的性能，或者是能量需（xū）求超過（guò）過濾器更換成本時，過濾器更換才有意義。但是，過濾（lǜ）器必須能通過泄漏測試（如上所述）。事實上，很多公司並不會使用一（yī）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（zhī）是根據經驗得來的。

靈潔高效（xiào）過濾器更換問（wèn）題

谘詢內容：老師您好，小容（róng）量（liàng）注射劑車間空調係統的高效過濾器必須定（dìng）期更換嗎？如不定期更換，隻（zhī）在空調驗證時（shí）更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（nǐ）好，更換高效過濾器根據空（kōng）調（diào）驗證參考：時風量和撿漏（lòu）是必須的，但同時也應製定出具體高效過濾器最長使用周期，故還是應該有定期（qī）的概念。同時必須定期進行過（guò）濾器完整性測試。

製藥廠高效過濾（lǜ）器一般多久（jiǔ）更換？

潔（jié）淨區A級高效過濾器檢漏

谘詢（xún）內容：潔淨區A級高效過濾器檢漏是否可以使用 塵埃粒子計數器 掃描檢（jiǎn）漏，如（rú）果可以，那麽判斷無泄漏的標準是多少。

CFDA審核查驗（yàn）中心回複：靈（líng）潔高效過濾器檢漏一般在非關鍵區域（yù）可以使用塵（chén）埃粒（lì）子計數器，但A級潔淨區高效過濾器不推薦使用塵埃（āi）粒子計數器掃描檢（jiǎn）漏