漳州製藥廠（chǎng）高效過濾器

關於（yú）高效過濾器（qì）的更換周期方麵的問題，很（hěn）多潔淨室用戶都很關心（xīn），畢竟高效過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（de）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（qì）（HEPA）用於生產空（kōng）間空氣的處理和過濾的終端過濾器。無菌生產要求強製使用高效過（guò）濾器，而固體和半固體劑型的生產有（yǒu）時也（yě）會使用。H13至H14（DIN1822）是高效過濾器的兩種（zhǒng），後者截留率為99.995%。但多（duō）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（yào）求每（měi）年更換過濾器，而（ér）不管檢測結果如何（hé）。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限（xiàn）的具體數值。根據GMP的要求，過濾器不得有泄漏，這需要通過（guò）確認和定期執行ISO14644-3中的（de）泄漏測試，無菌車間來說這是必須的。根據附（fù）錄1（PIC/S PI032-2）的技術詮釋，A/B級（jí）每6個（gè）月（yuè）進行泄漏測（cè）試，C/D級（jí）則為12個月。FDA無菌指南要求進行定（dìng）期檢查。附錄1的（de）要求在這裏也適用。泄漏（lòu）是可以修補的，但修補的麵積不能超過（guò）單個過濾（lǜ）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（guò）濾器（qì）並（bìng）不隻有完整性一件事情。過（guò）濾器（層）的負載以及上下遊壓差也很（hěn）重要。如果過濾器上下遊壓差升高，則送排風係統的能量（liàng）需求會（huì）增加，這樣才能維持必須的換氣次數。這樣的過濾（lǜ）器上下遊壓差可能（néng）會增加（jiā）通風係統的性能限（xiàn）製。為了保護高效（xiào）過濾器（qì），就要使用前端過濾器---通常是像（xiàng）F7和F9過濾器（EN779）這樣的精細過濾器（qì）。這些過濾器（qì）必須定期更換（huàn）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.

從實踐角度來看，91小视频（men）可以說（shuō）最長使用期（qī）限直接取決於上下遊壓差。隻有在上下遊壓差達到一定數（shù）值影響到通風係統的性能，或者是能量需求超過過濾器更換成本（běn）時，過濾（lǜ）器更（gèng）換才（cái）有意義（yì）。但是，過濾器必（bì）須能通過泄漏測試（如上（shàng）所述（shù））。事實上，很多公司（sī）並不會使用一個過濾器超過8年。正如前述（shù），並沒（méi）有法規規定這樣（yàng）的值，這（zhè）都隻是（shì）根（gēn）據經（jīng）驗得來的。

靈潔高效過濾器更換問題

谘詢內容：老師您（nín）好，小（xiǎo）容量注射劑（jì）車間空調係統（tǒng）的高效過濾（lǜ）器必須定期（qī）更換嗎？如不定期更換，隻在空調驗證時更換風量不合格房間高效（xiào）和撿漏不合（hé）格高效可以嗎？

CFDA審核查（chá）驗中心回複：你好，更換高效過濾器根（gēn）據空調驗證（zhèng）參考：時風量和撿漏是必須的，但同時也應製（zhì）定出（chū）具體高效過濾器最長使用（yòng）周期，故還（hái）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。

製藥廠高效過濾（lǜ）器一般多久更換？

潔淨區A級高效過濾器檢漏

谘詢（xún）內容：潔淨區（qū）A級高效過濾器檢漏是（shì）否可以使用 塵埃粒子計（jì）數器 掃描檢漏，如果可以，那麽判斷無（wú）泄漏的標準是多少。

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