金華製藥廠高效過濾器

關於高效過濾器的更換周期方（fāng）麵的問題（tí），很多潔淨（jìng）室用（yòng）戶（hù）都很關心，畢竟高（gāo）效過濾（lǜ）器決定著潔淨（jìng）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（guān）方麵的問題：高效過濾器（qì）的（de）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（guò）濾器（HEPA）用（yòng）於生產空間（jiān）空氣的處理和（hé）過濾的終端過濾器。無菌（jun1）生產要求強製使用（yòng）高效過濾器，而固體和半固（gù）體劑型的生產有時也會使用。H13至H14（DIN1822）是高（gāo）效過濾器的兩（liǎng）種，後者截留率為99.995%。但多（duō）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（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（yào）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文件中，要求每年更換過濾器，而（ér）不管檢測結果如何。這是否（fǒu）合理？在相關的（de）GMP指南中並沒有高效過濾器可以使用期限的具（jù）體數值。根據GMP的要求，過濾器不得有泄漏，這需要通過（guò）確認和（hé）定期執行（háng）ISO14644-3中的泄漏測試，無菌車（chē）間（jiān）來說這是必須的。根據附錄1（PIC/S PI032-2）的技（jì）術（shù）詮釋（shì），A/B級每6個月進（jìn）行泄漏（lòu）測試，C/D級則為12個月。FDA無菌指南要求（qiú）進行定期檢查。附（fù）錄1的要求在這裏也適用。泄漏是可以修補的，但修補的麵積不能超過單個過濾器（qì）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（zhěng）性一件事情。過濾器（層）的負載（zǎi）以及上下遊壓差也（yě）很重要（yào）。如果過濾器上下（xià）遊壓差升（shēng）高，則送排風係統的能（néng）量（liàng）需求會增加，這樣才能維（wéi）持必須的換氣（qì）次數。這樣的（de）過濾器上下遊壓差可能會增加通（tōng）風係統的性能限製。為了保護（hù）高效過濾器，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。這些過濾器必須定期更換以保護高效過濾（lǜ）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（shí）踐角度來看，嫩草影院可以說（shuō）最長使用期限直接取決於（yú）上下遊壓差。隻有在上下遊壓差達到一定數值影響到通風係統的性能，或（huò）者是能量（liàng）需求超過過濾器更換成本（běn）時，過濾器（qì）更換才有意義。但是，過濾器必須能通過泄（xiè）漏測試（如上所述）。事（shì）實上，很多公司並（bìng）不會（huì）使用一個過濾（lǜ）器（qì）超過8年。正如（rú）前述，並沒有法規規定這樣的值，這都隻是根（gēn）據經（jīng）驗得來的。

靈潔高效過濾器更（gèng）換問題

谘詢內容（róng）：老師您（nín）好，小容量注射劑車間空調係統的（de）高效過（guò）濾器必須定期更換嗎？如不定期更換，隻在空調驗證時（shí）更換風量不合（hé）格房間高（gāo）效和撿漏不合格高效可以嗎？

CFDA審核（hé）查（chá）驗中心回複：你好，更換高效過濾器根據空調驗證參考：時風量和撿漏是必須的，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（gài）念。同時必須定期進行（háng）過（guò）濾器完（wán）整性測試。

製藥廠高效過濾器一般多久更（gèng）換？

潔（jié）淨區A級高效過濾（lǜ）器（qì）檢漏

谘詢內容：潔淨區A級高效過濾器（qì）檢漏是否可以（yǐ）使用 塵埃粒子計數器 掃描檢漏，如果（guǒ）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粒子計數器，但A級潔淨區（qū）高效過濾器不推薦使用塵埃粒子計數器掃描檢漏