黃山製藥（yào）廠高效過（guò）濾器

關於高效過濾器的更換周期方麵（miàn）的問題，很多潔淨室用戶（hù）都很關心，畢（bì）竟高效過濾器決定著潔淨室的（de）潔淨度能否達到標準，就在前（qián）方草莓秋葵菠萝蜜黄瓜榴莲视频也（yě）整理過相關方麵的問（wèn）題：高效過濾器的更（gèng）換標（biāo）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）用於生產空間（jiān）空氣的處理（lǐ）和過濾的（de）終端過濾器。無（wú）菌生產要求（qiú）強（qiáng）製使用高效過濾器，而固體和半固（gù）體劑型（xíng）的（de）生產有時也會使用。H13至H14（DIN1822）是高效（xiào）過（guò）濾器的兩種，後者截留（liú）率（lǜ）為99.995%。但多久必須更（gèng）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（chǎng）高效過濾器一般多久更換？

我（wǒ）們（men）經常看到在（zài）公司內部文件中，要求每年更（gèng）換過濾器，而不（bú）管檢測結果如何。這是（shì）否合理？在相關的GMP指南中並沒有高效過濾器可以使（shǐ）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（tōng）過確認和定期執行ISO14644-3中的泄漏測試，無菌車間來說這是必須的。根據附錄1（PIC/S PI032-2）的技術詮釋，A/B級（jí）每6個月進行泄漏測試（shì），C/D級則為12個月。FDA無菌指南要求進行定期檢查。附錄1的要求在這裏也適用。泄漏是可以修（xiū）補（bǔ）的，但修補的麵積不能超過單個過濾（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（guò）濾器並不隻有完（wán）整性一件事情。過濾（lǜ）器（層）的負（fù）載以及上下遊壓差也很重要。如果過濾（lǜ）器上下遊壓差升高（gāo），則（zé）送排風係統（tǒng）的能（néng）量需求會增加，這（zhè）樣才能維持必須（xū）的換氣次數。這樣的過濾器（qì）上下遊壓差可能（néng）會增加通風係統的性能限製。為了保護（hù）高效過濾器，就要（yào）使用前端過濾器---通（tōng）常（cháng）是（shì）像F7和F9過濾（lǜ）器（EN779）這樣的精細過濾（lǜ）器。這些過濾（lǜ）器必須定期（qī）更換以保護高效（xiào）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，草莓秋葵菠萝蜜黄瓜榴莲视频可以說最（zuì）長使用期限直接取決於上下遊壓差。隻有在上下遊壓差達到一定數值影響到通風係統的性能（néng），或者是能量需（xū）求超過過（guò）濾器更換成本時（shí），過濾器更換才有意義（yì）。但是，過濾器必須能通過泄漏測試（如上所述）。事實（shí）上，很多公司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，這都隻是根據（jù）經驗得來的。

靈潔高效過濾器更換問題

谘詢（xún）內容：老師您好，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，隻在空調驗證時更換風量（liàng）不合格房（fáng）間高效和撿（jiǎn）漏不合格高效可以嗎？

CFDA審核查驗中心回複：你（nǐ）好，更（gèng）換（huàn）高效過濾器根據空調驗（yàn）證參考：時風量（liàng）和撿漏是必須（xū）的，但（dàn）同時也應製定出具體高效過濾器最長使用周期，故還是應該有定期的概念。同時必須定期（qī）進行過濾器完整性測試。

製藥廠高（gāo）效過（guò）濾（lǜ）器一般多久更換？

潔淨區A級高（gāo）效過濾（lǜ）器檢漏

谘詢內容：潔淨區A級高效過濾（lǜ）器檢漏是否（fǒu）可以（yǐ）使用 塵埃粒子計數器 掃描檢漏，如果可以，那麽判斷無泄漏的標準是（shì）多少（shǎo）。

CFDA審核查驗中心回複：靈（líng）潔高效過濾器檢漏（lòu）一般在非關鍵區域可以使用塵埃粒子計數器（qì），但A級潔淨區高效過濾器不推（tuī）薦使用塵（chén）埃粒子計數（shù）器掃描檢漏