黃山製藥（yào）廠高效過濾器

關於高效過濾（lǜ）器的更換周期（qī）方麵的問題，很多潔淨室用（yòng）戶都很關心，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（zài）前方嫩草影院也整理過相關方麵的問題：高效過濾器的更換標準（zhǔn）

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（yè），高效過濾器（HEPA）用於生產空間空氣的處（chù）理和過濾的終端（duān）過濾器（qì）。無菌生產要求（qiú）強製使用高效過濾器，而固（gù）體和（hé）半固體劑型的生產有時也會使（shǐ）用。H13至H14（DIN1822）是高效過濾（lǜ）器的兩種，後者截留（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（bān）多久更換？

嫩草影院經常看到在（zài）公司（sī）內部文件中，要求每年更換過濾器，而不管檢測結果如何。這是否合理？在相關的GMP指南中並沒有高效過濾器可以使用期限的（de）具體數值。根據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，無菌車間來說這是必須（xū）的。根據附錄1（PIC/S PI032-2）的技術（shù）詮釋，A/B級每6個月進（jìn）行泄（xiè）漏測試，C/D級則為12個月。FDA無菌（jun1）指南要求進行（háng）定期（qī）檢查。附錄（lù）1的要求在這裏也適用。泄漏是可以修補的，但修補的麵（miàn）積不能超過單個（gè）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（shì）情（qíng）。過濾（lǜ）器（層（céng））的負載（zǎi）以及上下遊壓差（chà）也很重要。如果（guǒ）過濾（lǜ）器上下遊壓差升高（gāo），則送排風係統的能量（liàng）需求會增加，這樣才能維持必須的換氣次數。這（zhè）樣的過濾器上下遊壓（yā）差（chà）可能會增加通風係統的性（xìng）能限製。為（wéi）了保護高效過濾器，就要使用前端過濾器（qì）---通常是像F7和F9過濾器（EN779）這樣的精細過濾器。這（zhè）些過濾器必須定期更換以保護高效（xiào）過濾器避（bì）免堵塞（sāi）

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（yǐ）說最長使用期限直接取決於上下遊（yóu）壓差。隻有在上下遊（yóu）壓差達到一定數值影響到通風係統的（de）性能，或者是能量需求超過過濾器更（gèng）換成本（běn）時，過濾器更換才有（yǒu）意義。但是（shì），過（guò）濾器必須能通過泄漏測（cè）試（如上所（suǒ）述）。事實上，很多公司並不會使用一（yī）個過濾器超過8年。正如（rú）前述（shù），並沒有法規規定這樣（yàng）的值，這都隻是根據經驗得來的（de）。

靈（líng）潔高效過濾器更換（huàn）問題

谘詢內容：老師（shī）您好，小容量注射劑車間空調係統的高（gāo）效過（guò）濾器必須定期更換嗎？如不定期更換，隻在空調（diào）驗證時更換（huàn）風量不合格（gé）房間（jiān）高效和撿漏不合格高效可以（yǐ）嗎？

CFDA審核查驗中（zhōng）心回複：你好，更換高效過濾器根據空調驗證參（cān）考：時風量和撿漏是必須的，但同時也應製定出具體高效（xiào）過濾器最長使用周期，故還是應該有（yǒu）定期的（de）概念。同時必（bì）須定期進行過濾器完整性測試。

製藥廠高效過濾器一般多久更換？

潔淨區（qū）A級高效過濾器檢漏

谘詢內容：潔淨（jìng）區A級高效過濾器檢漏是否可以使用 塵埃粒子（zǐ）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。

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