德州製藥廠高效過濾器

關於（yú）高效過（guò）濾器的更換周期方麵的問題，很多（duō）潔淨室用戶都很關心，畢（bì）竟高效（xiào）過濾器決定著潔淨（jìng）室的潔淨度能否達到標準，就在前方嫩草影院也整理過相關方（fāng）麵的（de）問題：高（gāo）效過濾器的更（gèng）換標準（zhǔn）

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和過濾的終端（duān）過濾器。無菌生產要求強製使用高效過濾器，而固體（tǐ）和半固體劑型的生產有時（shí）也會使用。H13至H14（DIN1822）是高效（xiào）過（guò）濾器的兩種，後者截（jié）留率（lǜ）為（wéi）99.995%。但多久必（bì）須更換（huàn）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（zhì）藥廠高效過濾器一（yī）般多久更換？

我（wǒ）們經常看到在（zài）公司內部文件中，要求每（měi）年更（gèng）換過濾器，而不管檢測結果如何。這是否合理？在相關的GMP指南中並沒（méi）有高效過濾器可以使用期限的具體（tǐ）數值。根（gēn）據（jù）GMP的要求，過濾（lǜ）器不得有泄漏，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（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（yuè）進行泄（xiè）漏測試，C/D級則為12個月。FDA無（wú）菌指南要求進行定期檢查。附錄1的（de）要求在這裏也適用。泄漏是可以修補的（de），但修補的麵積不能（néng）超過單個（gè）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（jìng）化高效過濾器（qì）並不（bú）隻有（yǒu）完整性一件（jiàn）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（shàng）下遊壓（yā）差升高，則（zé）送排風係統的能量需求會（huì）增加，這樣才能維持必（bì）須的換氣次數。這樣的過濾器上下（xià）遊壓差可能會增加通風係統的性能限製。為了保護高效過濾器，就要使用前端過濾器---通常是像F7和F9過濾器（EN779）這樣的精細（xì）過濾器。這些過濾器必須定期更換（huàn）以保（bǎo）護高（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，嫩草影院可以說最長使用期限直接取決於上下遊（yóu）壓（yā）差。隻有在上（shàng）下遊壓差達到一定數值（zhí）影響到通風係統的性能，或者是（shì）能量需求超過過濾器更換成本時，過濾器更（gèng）換才有意義。但是，過濾器必須能通過泄（xiè）漏測（cè）試（如上所述）。事實上，很多公司並不會使用一個過濾器超（chāo）過8年。正如前述，並（bìng）沒有法規規（guī）定這樣的值，這都隻是根（gēn）據經驗得來的。

靈潔高效過濾器更換（huàn）問題

谘詢內（nèi）容：老師（shī）您好，小容量注射劑車間空調係統的高效過（guò）濾（lǜ）器必須（xū）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（fáng）間高效和撿漏不合格高效可以嗎？

CFDA審核查驗中心回複：你好，更換高效過濾器根據空調驗證參考：時（shí）風量和（hé）撿漏是必須的，但（dàn）同（tóng）時也應製定出具體高效過濾器最長使用周期，故還是應該有定期的概念。同時必須定期進行過濾（lǜ）器完整性測試。

製藥廠高（gāo）效過濾器一般多久更換？

潔淨區A級高效過（guò）濾器檢漏

谘詢內容：潔淨區A級高效過（guò）濾器檢漏是否可以使用 塵埃粒子計數器 掃描檢漏，如果可以，那麽判斷無泄（xiè）漏的（de）標準（zhǔn）是多少（shǎo）。

CFDA審核查驗中心回複：靈潔高效過濾器檢漏一（yī）般在非關鍵區域可（kě）以使用塵（chén）埃（āi）粒子計數器，但A級潔淨區高效過濾（lǜ）器不推薦使用塵埃粒子（zǐ）計（jì）數器（qì）掃描檢漏