廈門製藥廠高效過（guò）濾器

關於高效過濾器的（de）更換周期（qī）方麵的問題，很多潔淨室用戶都很關心，畢竟高效過濾器決定著潔淨室（shì）的（de）潔淨（jìng）度能否達到標準，就在（zài）前方91小视频也整理過相關方麵的問題：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，高效過濾器（HEPA）用於生產空間空氣（qì）的處理和過濾的終（zhōng）端（duān）過濾器。無菌生產要（yào）求強製使（shǐ）用高效（xiào）過濾器，而固體和半固體（tǐ）劑型的生產有時也會（huì）使用（yòng）。H13至H14（DIN1822）是高效過濾器（qì）的兩種，後者截留率為99.995%。但（dàn）多久必須更換一（yī）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（kǎo）：（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（lǜ）器一般多（duō）久更換？

91小视频經常看到在公司內部（bù）文件中，要求每年更換（huàn）過濾（lǜ）器，而不管檢測結果如何（hé）。這是否合理？在相關的（de）GMP指南中並沒有高效過濾器可以（yǐ）使用期限的具（jù）體數值。根（gēn）據GMP的要求，過濾器不得有泄漏，這需要（yào）通過確認和定期執行ISO14644-3中的泄漏測試，無菌車間來（lái）說這是必（bì）須的。根據（jù）附錄（lù）1（PIC/S PI032-2）的技術詮釋，A/B級每6個月進行泄漏測試（shì），C/D級則為12個月。FDA無菌指（zhǐ）南（nán）要求進行定期（qī）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.

當然，廣州靈潔淨化高效過濾器並不隻有完（wán）整性（xìng）一（yī）件事（shì）情。過濾器（層（céng））的負（fù）載以及上下遊壓差也很重要。如果過濾器上下遊壓（yā）差升（shēng）高，則送（sòng）排風（fēng）係統的能量需求會增加，這（zhè）樣才能（néng）維持必須的（de）換氣次數。這樣的過濾器上下遊（yóu）壓差（chà）可能會增加通風係統（tǒng）的性能限製。為（wéi）了保護（hù）高效過濾器，就要使（shǐ）用前端過濾器---通常（cháng）是像F7和（hé）F9過濾器（EN779）這樣（yàng）的精細過濾器。這些過（guò）濾器必須定期更換以保護（hù）高（gāo）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（men）可以說最長使用期限直接取決於上下遊壓差。隻有在（zài）上下遊壓差達到一定數值影（yǐng）響到通風係統（tǒng）的性能，或者是能量需求超（chāo）過過濾器更換成本時，過濾器更換才有意義（yì）。但是，過濾器必須（xū）能通過泄漏測試（如上（shàng）所述）。事實上，很多公司（sī）並不（bú）會使用一個過濾器（qì）超過8年。正如前述，並沒有法規規定這（zhè）樣的值，這都隻是根據經驗得來的。

靈潔高效過濾器更換（huàn）問題（tí）

谘詢內容（róng）：老師您好，小容量注射劑車間空調係統的高效過（guò）濾器必須定期更換（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（xiào）和撿漏不合（hé）格高效（xiào）可以嗎（ma）？

CFDA審（shěn）核查驗中心回（huí）複：你好，更換高效過濾器根據空（kōng）調驗證參考：時風量和撿漏是必須的，但同時也應製定出具體高效過濾器最長（zhǎng）使用周期（qī），故還是應該有定（dìng）期的概念。同時必須定期進行（háng）過濾器完整性測試。

製藥（yào）廠（chǎng）高（gāo）效過濾器一般多久更換？

潔淨區A級高效（xiào）過濾器檢漏

谘詢內容：潔淨區（qū）A級高效過濾器檢（jiǎn）漏是否可以使用 塵（chén）埃粒子計數器 掃描檢漏，如果可以，那麽判斷無泄（xiè）漏的標準是多少（shǎo）。

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