攀枝花製藥廠高效過濾器

關（guān）於高效過（guò）濾（lǜ）器的（de）更換周期方（fāng）麵的問題（tí），很多潔淨室用戶都很關心，畢竟高效過濾（lǜ）器決定著潔淨室的潔淨度能（néng）否達到標準（zhǔn），就在前（qián）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（háng）業，高效過（guò）濾器（HEPA）用於生產空間空氣的處理和過濾的終端過濾器。無菌生產要求強製使用高效過濾器，而固體和半固體劑型的生產（chǎn）有時（shí）也會使用。H13至H14（DIN1822）是（shì）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（zhì）藥廠高效（xiào）過濾器一般多久更換？

草莓秋葵菠萝蜜黄瓜榴莲视频經常看到在公司內部文件中，要求每年更換過濾器，而不管檢（jiǎn）測結果如何（hé）。這是否合理？在相（xiàng）關的GMP指南中並沒有高效過濾器可以使用期限的具體（tǐ）數值。根據GMP的要求，過濾器不得有泄漏，這需要通過確認（rèn）和（hé）定期執行（háng）ISO14644-3中（zhōng）的（de）泄漏測試，無（wú）菌車間來說這是必須的。根（gēn）據附錄1（PIC/S PI032-2）的（de）技術詮釋，A/B級每6個月進行泄漏（lòu）測試，C/D級則為12個月。FDA無菌指南要求（qiú）進（jìn）行定期檢（jiǎn）查。附錄（lù）1的要求在這裏也適（shì）用。泄（xiè）漏是可以（yǐ）修補（bǔ）的，但修補的麵積不能超過（guò）單個過濾器（qì）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（guǎng）州靈潔淨化高效過（guò）濾器並不隻有完（wán）整性一件事情。過濾器（層）的負載以及上下遊壓差也很重（chóng）要。如果過濾器上下遊壓差升高，則送（sòng）排風係統的能量需求會增加，這樣才能維持必須的（de）換氣次數。這樣的過濾器上下遊壓差可能會增（zēng）加通風係統的性能限製。為了保（bǎo）護高效（xiào）過濾器（qì），就（jiù）要使用前端（duān）過濾器（qì）---通常是像F7和F9過濾器（EN779）這樣的精細過（guò）濾器。這些過濾器必須定期更換（huàn）以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.

從實踐角度來看，草莓秋葵菠萝蜜黄瓜榴莲视频可以說最長使（shǐ）用（yòng）期限直接取決於上下遊壓差。隻有在（zài）上下（xià）遊壓差達到一定數值影響到通（tōng）風係統的性能，或者是能量需（xū）求超過過濾器（qì）更換成本時，過濾器更換才有意義。但是（shì），過濾器必須能通（tōng）過泄漏測試（如上所述（shù））。事實上（shàng），很多公司並不會使用（yòng）一個過濾器超過8年。正如（rú）前述，並沒有法規規定這樣的值，這都隻是根據經驗得來的。

靈潔高效過濾器更換問題

谘（zī）詢內容：老師您好，小容量注射劑車間空調係統的高效過濾（lǜ）器必須定期更換嗎？如不定期更換，隻在空調（diào）驗證時更換風量不合（hé）格房間高（gāo）效和撿漏不合（hé）格高效可以嗎？

CFDA審核查驗中心回複（fù）：你好，更換（huàn）高效過濾器根據空調驗證參考：時風量和撿漏是必須（xū）的，但同時也（yě）應製定出具體高效（xiào）過濾（lǜ）器最長使用周期，故還是（shì）應該有定期的概念。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級高效過（guò）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 掃描檢漏，如果可以，那麽判斷無泄漏的（de）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（bān）在非關鍵區（qū）域可以使用塵埃粒子計數器，但A級潔淨區高效過（guò）濾器（qì）不推薦使用塵埃粒子計數器掃（sǎo）描檢漏