漢中製藥廠高效過（guò）濾器

關於高效過濾器的更換周期（qī）方麵的問題，很（hěn）多潔淨室用戶都很關心，畢竟高（gāo）效（xiào）過（guò）濾器決定著潔淨室的潔淨度能否達到標準，就在前方91小视频也整理過相關方麵的問題：高效（xiào）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?

在製藥行業，高效過濾器（HEPA）用於生產空間空氣（qì）的處理和過濾的終端過濾器。無菌生產要求強製（zhì）使用高效過濾器，而固體和半固體劑型的生產有時也會使用（yòng）。H13至H14（DIN1822）是高效過（guò）濾器的兩種，後者截留率為99.995%。但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？

91小视频經常看到在公司內部文件中，要求每年更換過濾器，而不管檢（jiǎn）測結果如何。這是否合理？在相關的GMP指南中並沒有（yǒu）高效過濾器可以使用期（qī）限的具體數值（zhí）。根據GMP的要求，過濾器不得有（yǒu）泄漏（lòu），這（zhè）需要通過確認和定期執行ISO14644-3中的泄漏測試，無菌車間來說這是必須的。根據附錄1（PIC/S PI032-2）的技術詮釋，A/B級每6個月進行泄漏測試，C/D級則為12個月。FDA無菌指南要求進（jìn）行定期檢查。附（fù）錄1的要求在（zài）這裏也適用。泄（xiè）漏是可以修補的，但修補的（de）麵積不能超過單個過（guò）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）化高效過濾器並不隻有完整性一件事情。過濾器（層）的（de）負載以（yǐ）及上下遊壓差也很重要。如果過濾器上下遊壓差升高，則送排（pái）風（fēng）係統（tǒng）的（de）能量需求會增（zēng）加，這（zhè）樣才能維持必須的換氣次數。這樣的過濾器上（shàng）下遊壓差可（kě）能會增加通風係統的性能限製。為了保護高效過（guò）濾器（qì），就要使用前端過濾器---通常是像F7和F9過濾器（EN779）這樣的（de）精細過濾器。這些過濾器必須定期更換以保護高效過濾器避免堵塞

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（cóng）實踐角度來看，91小视频可（kě）以說最長使用期限直接取決於上下遊壓差。隻有在上下（xià）遊壓差達到一定數值影響到通風係（xì）統的性能，或者是能量需求超過過濾器更換成本時，過濾器更換才有（yǒu）意義。但是，過濾器必須能通過泄漏（lòu）測試（如上所述）。事實（shí）上，很多公司並（bìng）不會使（shǐ）用一（yī）個過濾器超（chāo）過8年。正如前述，並沒有法規規定（dìng）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（wèn）題

谘詢內容：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（qī）更換嗎？如不定期（qī）更換，隻在空調驗證時（shí）更換風量不合格房間高效（xiào）和撿漏不（bú）合（hé）格高效可以嗎？

CFDA審核查驗（yàn）中心回複：你好，更換高效過濾器根據空調驗證參考：時風量（liàng）和撿漏是必須的，但同時（shí）也應製定出（chū）具（jù）體高效過濾器（qì）最（zuì）長使用周期，故還是應（yīng）該有定期的概念。同（tóng）時必須定期進（jìn）行過濾器完整性測（cè）試。

製藥廠高效過濾器一（yī）般多久更換（huàn）？

潔淨區A級高效過濾器檢漏

谘詢（xún）內容：潔淨區A級高效過濾器（qì）檢漏（lòu）是否可以使用 塵埃粒子計數器 掃描檢漏，如（rú）果（guǒ）可以，那麽判斷無泄漏的（de）標準是多少。

CFDA審核查（chá）驗中心回複：靈潔高效過濾器檢漏一般在非關鍵區域可以使用塵埃粒子計數器，但A級潔淨區高效過濾（lǜ）器（qì）不推薦使用塵埃粒子計數器掃（sǎo）描檢漏