鬆原製藥廠高效過濾器

關於高效過濾器的更換周期（qī）方（fāng）麵的問題，很多潔淨室用戶都很關心，畢竟高（gāo）效過濾器決定（dìng）著（zhe）潔淨室的潔淨度能否達到標準，就在前方嫩草影院也整理過相關方麵（miàn）的問題：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?

在製藥行業，高（gāo）效過濾器（HEPA）用（yòng）於生產空間空氣的處理和過濾的終端過濾器。無菌生產要求（qiú）強製使用高效過濾器，而固體和半固體劑型的生產有時也會使用。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（bān）多（duō）久更換？

我（wǒ）們（men）經常看到在公司內部文件中，要求每年更換過濾（lǜ）器，而不管檢測結果如何。這是否合理？在相關的GMP指（zhǐ）南中（zhōng）並沒有（yǒu）高效過濾器可以使（shǐ）用（yòng）期限的具體數（shù）值。根據GMP的要（yào）求，過（guò）濾器不得（dé）有泄漏（lòu），這需要（yào）通過確認和定（dìng）期執（zhí）行ISO14644-3中的泄漏測試，無菌車間來說這是必須（xū）的。根據附錄1（PIC/S PI032-2）的技術（shù）詮釋（shì），A/B級每6個月（yuè）進行泄漏測試，C/D級則為12個（gè）月。FDA無（wú）菌指南要求進行定（dìng）期檢查。附錄1的要求在（zài）這裏也適用。泄漏是可以修補的，但修（xiū）補的麵積不能（néng）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（dāng）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（yǐ）及上下遊壓差也很重要（yào）。如果（guǒ）過濾器上下遊壓差升高，則送排風係統的能量需求會增加，這（zhè）樣才能（néng）維持必須的換氣次數。這樣的過（guò）濾（lǜ）器上下遊壓差可（kě）能會增加（jiā）通風係統（tǒng）的性能限製。為了保護高效過濾器，就要（yào）使用前端（duān）過（guò）濾器---通常是像（xiàng）F7和F9過濾器（EN779）這樣的精細過（guò）濾（lǜ）器（qì）。這些過濾器必須定期更換以保護高（gāo）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（cóng）實踐角度來（lái）看，嫩草影院可以說最長使用期限直接取決於上下（xià）遊壓差。隻有在上下遊壓差（chà）達到一定數（shù）值影響到通風係統的性能，或者是能（néng）量（liàng）需求超過過濾器更（gèng）換成本時，過濾器更換才有意義。但是，過濾器必須能通過泄漏測（cè）試（如上所述）。事實上，很多公司並不會使用一個過（guò）濾器超過8年。正如前述，並（bìng）沒有（yǒu）法（fǎ）規規定（dìng）這樣的值，這都隻是根據經驗得來的。

靈（líng）潔（jié）高效過濾器更換問題

谘（zī）詢內容：老師您好，小容量注射劑車間空調係統的（de）高效過濾器必（bì）須定期更換嗎？如不定期更（gèng）換，隻在空調驗證時更換風（fēng）量不（bú）合格房間高效（xiào）和撿漏不合格（gé）高效可以嗎（ma）？

CFDA審核查驗中心回複：你好，更（gèng）換高效（xiào）過濾器根據空調驗證（zhèng）參考：時風量和撿漏是（shì）必須的，但（dàn）同時也應製定出具（jù）體高效過濾器最長使用周期，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（chǎng）高效過濾器一般多久更換？

潔淨區A級高效過濾器檢漏

谘詢內容：潔淨區A級高效（xiào）過濾器檢漏是否可以使用 塵埃粒子計數器 掃描檢漏，如果可以，那麽判斷無泄漏的標（biāo）準是多少。

CFDA審核查驗中心回複：靈潔（jié）高效過濾器檢漏一般在非關鍵區域（yù）可（kě）以使用塵（chén）埃粒子計數器，但A級潔淨區高效過濾器不推薦使用塵埃粒（lì）子計數器掃描檢漏