銅川製藥廠高效過濾器

關（guān）於高（gāo）效（xiào）過濾器（qì）的更換周期方麵（miàn）的問題，很多潔淨室用戶都很（hěn）關心，畢竟高效（xiào）過濾器決（jué）定著潔（jié）淨室的潔淨度能（néng）否達到標準，就（jiù）在前方嫩草影院也整理過相關（guān）方麵的問題：高效過濾器的更換標（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（zài）製藥行（háng）業（yè），高效過（guò）濾器（qì）（HEPA）用於生產空間空氣的處理和過濾（lǜ）的終端過濾器（qì）。無菌生產要求強製使用高效過濾器，而固體和半（bàn）固體劑型的生產有時也會使用。H13至H14（DIN1822）是高效過濾器的兩種，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（cān）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？

嫩草影院經常看到在公司（sī）內部文件中，要求每（měi）年（nián）更換過濾器，而不管檢測結果如何。這是否合理？在相關的GMP指南中並（bìng）沒有高效過濾器可以使用期限的具體數（shù）值。根據（jù）GMP的要求，過濾器不得有泄漏，這需（xū）要通過確認和定期執行ISO14644-3中的泄漏測試，無（wú）菌車間來說這是必（bì）須的。根據（jù）附（fù）錄1（PIC/S PI032-2）的技術詮釋，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（yào）求進行定期（qī）檢查。附錄1的要求在這裏也適用。泄漏（lòu）是可以修補的，但修補的麵積不能（néng）超過單（dān）個過濾器麵積的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，廣州靈潔淨化高效過濾器（qì）並不隻有完整性一件（jiàn）事情（qíng）。過濾器（層（céng））的負載以（yǐ）及上下遊壓差也很重要。如果過濾器上下遊壓差升（shēng）高，則送排風係統的能量需求會增加，這樣才能維持必須的換氣次數。這樣的過濾器上下遊壓差可能會增加通風係統的性能限製。為了保護高效過濾器，就要使用前端過濾器---通常是像F7和F9過濾器（EN779）這樣的精細過濾（lǜ）器。這些過（guò）濾器必須定（dìng）期更換以保護高效過濾器避免堵（dǔ）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，嫩草影院可以說最長（zhǎng）使用（yòng）期限直接取決於上下遊（yóu）壓差。隻有在上下遊壓差達到一定（dìng）數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（chéng）本時，過濾器（qì）更（gèng）換才有意義。但是，過濾器必須能通過泄漏測試（shì）（如上所述）。事實上，很多公司並不（bú）會使用一（yī）個過濾器超過8年。正如前述，並沒（méi）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

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

CFDA審核查驗中心回複：你好，更換高效過濾器根據空調（diào）驗證參考：時風量和撿漏是（shì）必須的，但同時（shí）也應製定出具體高效（xiào）過濾（lǜ）器最長使用周期，故還（hái）是應該有定（dìng）期的概念。同時必須（xū）定期進行過濾器完整性測試。

製藥廠高效過濾器一般（bān）多久更換？

潔淨（jìng）區A級高效過濾器檢漏（lòu）

谘詢內容：潔淨區A級高效過濾器檢漏是否可以使用 塵埃粒子計數（shù）器 掃描檢漏，如果（guǒ）可以，那麽判斷（duàn）無泄（xiè）漏的標準是多少。

CFDA審核查驗中心回複：靈潔高效過濾器檢（jiǎn）漏一般在（zài）非關鍵（jiàn）區域可以使（shǐ）用塵埃粒子計數（shù）器，但A級潔（jié）淨區高效過濾器不推薦（jiàn）使用塵埃粒子計數器掃描（miáo）檢漏