澄邁縣製藥廠高效過濾器

關（guān）於高效過濾器的（de）更換周期方麵的問題，很多潔淨室用戶都很關心，畢竟高（gāo）效過濾器決定（dìng）著潔淨室的潔淨度能否達到標（biāo）準，就在前方嫩草影院也整理過相關方麵的問題：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，高效（xiào）過濾器（qì）（HEPA）用於生產空間空（kōng）氣的處理和（hé）過濾的終端過濾器。無菌生產要求強製使用（yòng）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）是高效過濾器的兩種，後者截留率為99.995%。但（dàn）多久必須更換一次（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.

製藥廠高效過濾器（qì）一般多久更換？

嫩草影院經常看到在公司內部文件中，要求每年更換過濾器，而（ér）不管檢測結果如何。這是否合理？在相關的GMP指南中並沒有高效過濾器可以使用期限的具體數值。根據（jù）GMP的要求，過濾器不得有（yǒu）泄漏，這需（xū）要通過（guò）確（què）認和定期執（zhí）行ISO14644-3中的（de）泄（xiè）漏測試，無菌車（chē）間來說（shuō）這是必須的。根據附錄（lù）1（PIC/S PI032-2）的技術詮釋，A/B級每6個月進行（háng）泄漏測試（shì），C/D級則為12個月。FDA無菌指南（nán）要求進行定期檢查。附錄1的要求在這裏也（yě）適用。泄（xiè）漏是可以修補的，但修補（bǔ）的麵積不能超（chāo）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（huà）高效過濾器並不隻有完整性一件事情。過濾器（qì）（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（chà）升高，則送（sòng）排風係統（tǒng）的能量需求會增加，這樣才能維持必須的換氣次數。這樣的過濾器上下遊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（guò）濾器---通常是像F7和F9過（guò）濾器（qì）（EN779）這樣的精細過濾器。這些過濾器必須定期（qī）更換以保護（hù）高（gāo）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.

從實踐角（jiǎo）度來看（kàn），嫩草影院可以說最長使用期（qī）限直接取決於上（shàng）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（zhě）是能量需求超過過濾器更換成本時，過濾器更換才有意義。但（dàn）是，過濾器必須能通過泄漏測試（如上所述）。事實上，很多公（gōng）司並不會使用一個過濾（lǜ）器超過8年（nián）。正如前述，並沒有法規（guī）規定這樣的值，這都隻是根據經（jīng）驗得來的。

靈潔高效過濾器更換問題

谘詢內容：老師您好（hǎo），小容量注射劑（jì）車間空調係統的高效過濾器必須定期更換嗎？如不定期（qī）更換（huàn），隻在空調驗證時更換風量（liàng）不（bú）合格房間高效和撿漏不（bú）合格高效可以嗎？

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

製藥廠（chǎng）高效過濾器（qì）一般多久更換？

潔淨區A級高（gāo）效過濾器（qì）檢漏

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

CFDA審核查驗中心回複：靈（líng）潔高效過濾器（qì）檢（jiǎn）漏一般在非關鍵區域（yù）可以使用（yòng）塵埃粒子計數器，但A級（jí）潔淨區高（gāo）效過濾器不推薦使用塵埃粒子計數（shù）器掃描檢漏