長春製藥廠高效過（guò）濾器

關於高（gāo）效過（guò）濾器的更換周期方麵（miàn）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的潔淨度能否達到標準，就在前方草莓秋葵菠萝蜜黄瓜榴莲视频也整理過相關方麵的問題：高效過濾器的（de）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（háng）業，高效過（guò）濾器（HEPA）用（yòng）於生產空間空（kōng）氣的（de）處理和過濾（lǜ）的終端過濾器。無菌生產要求強（qiáng）製使用高效過濾器，而固體和半固（gù）體劑型的生（shēng）產有時也會（huì）使用（yòng）。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（chǎng）高效過濾器（qì）一（yī）般多久（jiǔ）更換？

草莓秋葵菠萝蜜黄瓜榴莲视频（men）經常看到在公司內部文（wén）件中，要求每（měi）年更換過濾器，而不管（guǎn）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具體數值。根據GMP的要求，過濾器不得（dé）有泄漏，這需要通過（guò）確認和定期（qī）執行ISO14644-3中的泄漏測試，無菌（jun1）車間來說這是必須的。根據附（fù）錄1（PIC/S PI032-2）的技術詮釋（shì），A/B級每6個（gè）月進行泄（xiè）漏測試，C/D級則為（wéi）12個月（yuè）。FDA無菌指南要求進行定期檢（jiǎn）查。附錄1的要求（qiú）在這裏也適用（yòng）。泄漏是可（kě）以修補的，但修補的麵（miàn）積不能超（chāo）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（huà）高效過濾器並不隻有完整性一件事情。過（guò）濾器（層）的負載以及上下遊壓差（chà）也（yě）很重要。如果過濾器上（shàng）下遊壓差升高，則送排（pái）風係統的能量需（xū）求會增加（jiā），這樣（yàng）才能（néng）維持必須的換氣（qì）次數。這樣的過濾器上下遊壓差可能（néng）會增加通風係統的性能限製。為了保護高效（xiào）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（yàng）的精細過（guò）濾器。這些過濾器必須（xū）定期更換以保護高效過濾器避免堵塞

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（cóng）實踐角度來（lái）看，草莓秋葵菠萝蜜黄瓜榴莲视频可以說最長使用期限（xiàn）直接取決於上下遊（yóu）壓差。隻有在（zài）上下遊壓（yā）差達到一定數（shù）值影響（xiǎng）到通風係統的性能，或者是（shì）能量需求超過過濾器更換成本時，過濾器更換才有意（yì）義。但是，過濾器必須能通過泄漏測試（如上所述）。事實上，很多（duō）公司並不會使用一個過（guò）濾器超過8年。正如前述，並（bìng）沒有法規規定這樣的（de）值，這都隻是（shì）根據經驗得來的（de）。

靈潔高效過濾器更換問題

谘詢內（nèi）容：老師您好，小容量注射劑車間空調係統的高效過濾器必須定期（qī）更換嗎？如不定期更（gèng）換，隻在空調驗（yàn）證時更換風量不（bú）合（hé）格房間高效和撿漏不合格高效（xiào）可以嗎？

CFDA審核查驗中心回複：你（nǐ）好（hǎo），更換高效過（guò）濾器根據空調（diào）驗證參考：時風量和撿漏是（shì）必須的（de），但同時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（qī）的概念。同時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（jí）高效過濾器檢漏

谘（zī）詢內（nèi）容：潔淨區（qū）A級高效過濾器檢漏是否可以（yǐ）使用 塵埃粒子計數器 掃描檢漏，如果可（kě）以，那麽判斷無泄漏的標準是多少。

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（yǐ）使用塵埃粒子計數器，但A級潔淨區高效過濾器不推薦使用塵埃粒子計數器掃描檢漏