製藥廠高（gāo）效過濾器

關於高效過（guò）濾器的更換周期方麵的問題，很多潔淨室用戶都（dōu）很關心，畢竟高效過濾器決定著潔淨室的潔淨度能（néng）否達到標準，就在前方（fāng）草莓秋葵菠萝蜜黄瓜榴莲视频也（yě）整理過相（xiàng）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?

在製（zhì）藥行業，高效過濾器（HEPA）用於生產空（kōng）間空氣的處理和過濾的終（zhōng）端過濾器。無菌生產要求強製使用高效過濾器，而固體和半固體劑型的生產有時（shí）也會使用。H13至H14（DIN1822）是高（gāo）效過濾器的（de）兩種，後者截留率為（wéi）99.995%。但（dàn）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？

草莓秋葵菠萝蜜黄瓜榴莲视频經常看到在公司內（nèi）部文件中，要求（qiú）每年更換過濾器，而（ér）不管檢（jiǎn）測結果如何（hé）。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（zhí）。根據GMP的（de）要求，過（guò）濾器不（bú）得有泄漏，這需要通過確認和定期執（zhí）行ISO14644-3中的泄（xiè）漏測試，無菌車間來說這是必須的（de）。根據附錄1（PIC/S PI032-2）的技術（shù）詮釋，A/B級每6個月進行泄漏測（cè）試，C/D級則為12個月。FDA無菌指南要（yào）求進行定期檢查。附錄1的要求（qiú）在這裏也適用（yòng）。泄漏是可以修補（bǔ）的（de），但修補的麵積不能超（chāo）過單個過濾（lǜ）器（qì）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（dāng）然，廣州靈潔淨（jìng）化高效過（guò）濾器並不隻有完整性一（yī）件事情。過濾器（層）的（de）負載以及上下遊壓差也很重要。如果（guǒ）過濾器上下遊壓差升高，則送排風係統的能量需求會增加，這樣才能維持必（bì）須的換（huàn）氣次數（shù）。這樣的過（guò）濾器上下遊壓差可能（néng）會增加通風係統（tǒng）的性能限製（zhì）。為了保護高效過（guò）濾器，就要（yào）使用前端過濾器（qì）---通（tōng）常是像F7和F9過（guò）濾器（EN779）這樣的精細過濾（lǜ）器。這些過濾器必須定期更（gèng）換以保護高效過濾器避（bì）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，草莓秋葵菠萝蜜黄瓜榴莲视频（men）可以說最長使用期限（xiàn）直接取（qǔ）決於上下遊（yóu）壓差。隻有在上下遊壓差達到（dào）一定數值影響到通風係統的性能，或者（zhě）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（yì）。但是，過（guò）濾器必須能通（tōng）過（guò）泄漏測（cè）試（如上所述）。事實上（shàng），很多公司（sī）並不會使用一個過濾器超過8年。正如前述，並沒有法規規定這樣的值，這都隻是根（gēn）據經驗得來的。

靈潔高效過濾器更換（huàn）問題（tí）

谘詢內容：老師（shī）您好，小容量注射劑車間空調係統的高效過濾器必須定期更換嗎？如不定期更換，隻在空調驗（yàn）證（zhèng）時更（gèng）換風量不合格房間高（gāo）效和撿漏不合格高效可以嗎？

CFDA審核查（chá）驗中心回複：你好（hǎo），更換高效過濾器根據（jù）空調驗（yàn）證（zhèng）參考：時風量和撿漏是必須的，但同時也應製定出具體高效過濾器最（zuì）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（guò）濾器完整性測試。

製藥（yào）廠高效過濾器（qì）一般多久更（gèng）換？

潔淨區A級高效過濾器檢漏

谘詢（xún）內（nèi）容：潔淨區（qū）A級高效過濾器（qì）檢漏是否可以（yǐ）使用 塵埃粒子計數器（qì） 掃描檢漏，如果可以，那麽判斷無泄漏的標準是多（duō）少（shǎo）。

CFDA審核查驗中（zhōng）心（xīn）回複：靈潔高效過濾（lǜ）器檢（jiǎn）漏一般（bān）在非（fēi）關鍵區域可以（yǐ）使用（yòng）塵埃粒（lì）子計數器，但A級潔淨區高效過濾器不推薦使用塵（chén）埃粒（lì）子計數器掃描檢漏