張家口製藥廠（chǎng）高效過濾器（qì）

關於高效過濾器的更換周期方（fāng）麵的問題，很多潔淨室用戶都很關心，畢竟高效過濾器決定著潔淨室的（de）潔淨度（dù）能否達到標準，就在前方嫩草影院也整理（lǐ）過相關（guān）方麵的問題：高效過濾（lǜ）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，高效過濾器（HEPA）用於生（shēng）產空（kōng）間空（kōng）氣的處理和過濾的終端過濾（lǜ）器。無菌生產要求強製使用高效過濾器，而固體（tǐ）和半（bàn）固體劑型的生產有時也會使用。H13至H14（DIN1822）是高效（xiào）過濾器的兩種，後者截（jié）留（liú）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？

嫩草影院經常看到在公司內部（bù）文件中，要求每年（nián）更換過濾器，而不管檢測結果如（rú）何。這是否（fǒu）合理？在相關的GMP指南中並沒有高效過濾器（qì）可以使用期限的具（jù）體數值。根據GMP的要求，過濾（lǜ）器不得有泄漏（lòu），這需要通過確認（rèn）和定（dìng）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（yuè）進行泄漏測（cè）試，C/D級則（zé）為12個月。FDA無菌指南（nán）要求進行定期檢查。附錄1的要求在這裏也適用。泄漏是可以修補的，但修補的麵積（jī）不能超過單個過濾器麵積的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並不隻有完整性一件事情。過濾器（層）的負載以及上（shàng）下遊壓差（chà）也很重要。如（rú）果過濾器上下遊壓差升高，則送排風係統的（de）能量需求會增加，這樣才（cái）能（néng）維持必須的換氣次數。這樣的過濾（lǜ）器上下遊（yóu）壓（yā）差可能會增加通風係統的性能限製。為（wéi）了保護高效（xiào）過濾器，就要使用前（qián）端過（guò）濾器---通常是像F7和F9過濾器（EN779）這樣的精細過濾器。這些過（guò）濾器必須定期更換以（yǐ）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，嫩草影院可以說最長使用期限（xiàn）直接取決於上（shàng）下遊壓差。隻有在上下（xià）遊壓差達到一定數值（zhí）影響到通風係統的性能，或（huò）者是能量需求超過過濾（lǜ）器更換成本（běn）時，過濾器更換才有意義。但是，過濾器必須能通過泄漏測試（如上所述）。事實上，很多公（gōng）司（sī）並不會使用（yòng）一個（gè）過濾器（qì）超過8年。正如前述（shù），並沒有法規規定這樣的（de）值，這都隻是根據經驗得來的。

靈（líng）潔高效過濾器更換問（wèn）題

谘詢內容：老師您好，小容量注射（shè）劑車間空調係統的高（gāo）效過（guò）濾器必須定（dìng）期更換（huàn）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和撿漏不合格高效可以嗎？

CFDA審核查驗中心回複：你好（hǎo），更換高效過濾器（qì）根據空調（diào）驗證（zhèng）參考（kǎo）：時風量和撿漏是必須的，但同時也應製（zhì）定出具體高效過濾器最長使用周（zhōu）期，故還是應該（gāi）有定（dìng）期的概念。同時必須定期進行過濾器完整性測試。

製藥廠高效過濾器一般多（duō）久更換？

潔淨區A級高效過濾器檢漏

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（zǐ）計數（shù）器 掃描檢漏，如果可以，那麽判斷無泄漏的標準是多少。

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