大同製藥廠（chǎng）高效過濾器

關於高效過濾器的更換周期（qī）方麵的問題，很多潔淨室用戶都很關心，畢竟高（gāo）效（xiào）過濾器（qì）決定著潔淨室的潔淨度能否（fǒu）達到標準，就在前方我（wǒ）們也整理過相關方麵的問題：高效過濾器的更（gèng）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（lǜ）器（HEPA）用於生（shēng）產空（kōng）間空氣的處理和過濾的終端過濾器。無菌生產要求強（qiáng）製使用高效（xiào）過濾器（qì），而固（gù）體和半固（gù）體劑型的生產有時也會使用（yòng）。H13至H14（DIN1822）是高效過濾器的兩種，後者截（jié）留率為99.995%。但多久（jiǔ）必（bì）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？

91小视频經常看到在公司內部文件中，要求每（měi）年更換（huàn）過濾器，而（ér）不管檢測結果如何。這（zhè）是否（fǒu）合理？在相關的GMP指（zhǐ）南中並沒有高效過濾（lǜ）器可以使用期限的具體數值。根據GMP的要求，過濾器不得有泄（xiè）漏（lòu），這需要通（tōng）過確認和定期執行（háng）ISO14644-3中的泄漏（lòu）測（cè）試，無菌車間來說（shuō）這是必（bì）須的。根據附（fù）錄1（PIC/S PI032-2）的技（jì）術詮釋，A/B級每6個月進行（háng）泄漏測試，C/D級（jí）則為12個月。FDA無菌指南（nán）要求進行（háng）定期檢查。附錄1的要求在這裏也適用。泄（xiè）漏是可（kě）以修補（bǔ）的，但修（xiū）補的麵積不能超過單個過濾器麵（miàn）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（jiàn）事（shì）情。過濾器（層（céng））的負載以及上下遊壓差也很重要。如果過濾（lǜ）器上下遊壓差升高，則送排風係統的能量需求會增加，這樣才能維持必須（xū）的換氣（qì）次數。這樣的過濾器（qì）上下遊（yóu）壓差可能會增加通風係統的性能限製。為了保護高（gāo）效過濾器，就要使用前端過濾器---通常是像F7和F9過濾器（EN779）這樣的精細過濾器。這些過濾（lǜ）器（qì）必（bì）須定期更換以（yǐ）保護高效過濾器避免（miǎn）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（jiǎo）度來看，91小视频可以說最長使用期限直接取決於上下遊壓差。隻有在上下遊壓差達到一定數（shù）值影響到通（tōng）風係統的性能，或（huò）者是能量（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（shì），過濾器必須能通過泄漏測試（如上所述）。事實上（shàng），很多公司並不（bú）會使用一個（gè）過濾器超過8年。正如（rú）前述，並沒有法規規定這樣（yàng）的值，這都隻是根（gēn）據經驗得來的。

靈潔高效過濾器更換問題

谘詢（xún）內容：老師您好，小容量注（zhù）射劑車間（jiān）空調（diào）係統的高效過濾器必須定期更換嗎？如不（bú）定期（qī）更換，隻在空調驗證時更換風量不（bú）合格房間高效和（hé）撿漏不（bú）合格高效（xiào）可以嗎？

CFDA審核查驗中心回複：你好，更換高效過濾器根據空調驗證參考（kǎo）：時（shí）風量和（hé）撿漏是必須的，但同時（shí）也應製定出具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（shí）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 塵埃粒子計數器（qì） 掃描檢漏，如果可以，那麽判斷（duàn）無（wú）泄漏的標準是多少。

CFDA審核查驗中心（xīn）回複：靈潔高效過（guò）濾器檢漏一般在非關鍵區域可以（yǐ）使（shǐ）用（yòng）塵埃粒子計數器（qì），但A級潔（jié）淨區高效過濾器不推薦使用塵埃粒子計數器掃描檢漏