普洱製藥廠高效過濾器

關於高效過濾器的更換周（zhōu）期方麵的問題，很多潔淨（jìng）室用戶都很關心，畢（bì）竟高（gāo）效過濾器決定著（zhe）潔淨室的潔淨度能否（fǒu）達（dá）到標準，就（jiù）在前方草莓秋葵菠萝蜜黄瓜榴莲视频也整理過相關方麵的問題：高效過（guò）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，高效過濾（lǜ）器（HEPA）用（yòng）於生產空間空氣的處理和過濾（lǜ）的終（zhōng）端（duān）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也會使（shǐ）用（yòng）。H13至H14（DIN1822）是高效過濾（lǜ）器的兩種，後者截留率為99.995%。但多久必（bì）須更換一（yī）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（gāo）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部文件中，要求每年更（gèng）換過濾器，而不管檢測結（jié）果如何。這是否合理（lǐ）？在相關（guān）的（de）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的要求，過濾（lǜ）器不得有泄漏，這需要通過確認和定期執行（háng）ISO14644-3中的泄漏測試，無菌車間來說這是必須（xū）的。根據附錄1（PIC/S PI032-2）的技（jì）術詮釋，A/B級每6個（gè）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（jiǎn）查。附錄1的要求在這裏也適用。泄漏是可（kě）以修補的，但修補的麵積不能超過單（dān）個過濾器麵積的（de）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，廣州靈潔淨化高效過濾器並不隻有完整性一件事情。過濾器（層）的負（fù）載以及上下（xià）遊壓差也很重要。如果過（guò）濾器上下遊壓差升高，則（zé）送排風係（xì）統的能量需求會增加（jiā），這樣才能維持（chí）必須的換氣次數。這樣的（de）過濾器上下遊壓差可能（néng）會增加通風（fēng）係統的性能限製。為了保（bǎo）護（hù）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以保（bǎo）護高效過濾器（qì）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（jiàn）角度（dù）來看，草莓秋葵菠萝蜜黄瓜榴莲视频可以說最長使用期限（xiàn）直接取決於（yú）上下遊壓差。隻有在上下遊壓差達到（dào）一定數值影響到通風係統的性（xìng）能，或者是能量需求（qiú）超過過（guò）濾器更（gèng）換成（chéng）本時，過濾器更換才有意（yì）義。但是，過濾（lǜ）器必須能通過泄漏測試（如上（shàng）所述）。事實上（shàng），很多公（gōng）司並不會（huì）使用一個（gè）過濾器超過8年（nián）。正如前述，並沒有法（fǎ）規規定這樣的（de）值（zhí），這都隻是根據經驗得來的。

靈潔高效過濾器更換（huàn）問題（tí）

谘詢內容：老師您（nín）好，小容量注射劑車間空調係統的高效過濾器必須定期更（gèng）換嗎？如不定（dìng）期更換，隻在（zài）空調驗證時更換風量不合（hé）格房間高效和撿漏不（bú）合格（gé）高效可以嗎？

CFDA審（shěn）核查驗中心回複（fù）：你（nǐ）好，更（gèng）換高效過濾器根據空調驗證參考：時風量（liàng）和撿漏是必須（xū）的，但同時也應製定出具體高效過濾器最（zuì）長使用（yòng）周期，故還是應（yīng）該有定期的概念。同時必須定期進行過濾（lǜ）器完整（zhěng）性測試。

製藥廠（chǎng）高效過（guò）濾器一（yī）般多久更換？

潔淨區A級高效過濾器檢漏

谘詢內（nèi）容：潔淨區A級高（gāo）效過濾器（qì）檢漏是否可以使用 塵埃粒子計數器 掃描（miáo）檢漏，如果可（kě）以，那麽判斷無泄漏（lòu）的標準是多少。

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