韶關（guān）製藥廠高效（xiào）過（guò）濾器

關於高效（xiào）過（guò）濾器的更換周期方麵的問題，很多潔淨室用戶都（dōu）很關心，畢竟高效過濾器決定著潔淨室的潔淨度能否達到標準，就在前方我（wǒ）們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?

在製藥行（háng）業，高效過濾器（HEPA）用於生（shēng）產空間空氣的處（chù）理和過濾的終端過濾器。無菌生產要求強製使用高效過濾器，而固體和（hé）半固（gù）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%。但多久必須（xū）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（huàn）？

91小视频經常看到（dào）在公司內（nèi）部文（wén）件（jiàn）中，要求每年更換過濾器，而不管檢測結（jié）果如何。這是否合理？在（zài）相關（guān）的GMP指（zhǐ）南中並沒有高效過濾器可以使用期限（xiàn）的具體數（shù）值。根據GMP的要求，過濾器不得有泄漏，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（bì）須的。根據附錄1（PIC/S PI032-2）的技術詮釋，A/B級每6個月進（jìn）行（háng）泄漏（lòu）測試，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（kě）以修補的，但修補的麵積不能超過（guò）單個過濾器麵積（jī）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（jié）淨化高效過濾器（qì）並不隻有完整性一件事情。過（guò）濾器（層）的負載以及上下遊壓（yā）差也很重要。如果（guǒ）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（jiā），這樣才能維持（chí）必須的換氣次數。這（zhè）樣的過濾器上下（xià）遊壓差可（kě）能會增加通風係統的性能限製。為了保護高效（xiào）過（guò）濾（lǜ）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（guò）濾（lǜ）器。這些過（guò）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.

從實踐角度來看，我（wǒ）們可以說最長使用期限直接取決於上下遊壓差。隻（zhī）有在上下遊壓差達到一（yī）定（dìng）數值影響到通風係統（tǒng）的性能，或者是能量需求超過過濾（lǜ）器更換成本時，過濾器（qì）更換才有（yǒu）意義。但是（shì），過濾器（qì）必須能通過泄漏測（cè）試（如（rú）上所述）。事實上（shàng），很多公司並不會使用一個過濾（lǜ）器超過8年。正如前述，並沒有法規規（guī）定這樣的值，這（zhè）都隻是根據經驗得來的。

靈潔高效過濾（lǜ）器更換問題

谘詢內（nèi）容：老師您（nín）好，小容量注射劑車間空調（diào）係統的高效過（guò）濾器必須定期更（gèng）換（huàn）嗎（ma）？如不定期更換，隻在空調驗證時更換風（fēng）量不合格房間高（gāo）效和撿漏不合格高效可以嗎？

CFDA審（shěn）核查驗中心回複：你好，更（gèng）換高效過濾（lǜ）器根據空調驗證參（cān）考：時風量和撿漏是必須的，但同（tóng）時也應製定出具體高效（xiào）過濾器最長使用周（zhōu）期，故還是應該有定期的概念。同時必須定期進行過濾器完（wán）整性測試。

製藥廠高效過（guò）濾器（qì）一般多久更換？

潔淨區A級高效過濾器（qì）檢漏

谘詢內容：潔淨區A級高效過濾（lǜ）器檢漏是否可以使（shǐ）用 塵埃粒子計數器 掃描檢漏，如果可（kě）以，那麽判斷無泄漏的（de）標準是多少。

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