焦作製藥（yào）廠高效過濾器

關於高效過濾器的更（gèng）換周期方麵的問題，很多潔淨室（shì）用戶都很關心，畢竟高效過濾器決定著（zhe）潔淨室的潔淨度能否達到（dào）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（wèn）題：高效過濾器的更（gèng）換標（biāo）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?

在製藥行業，高效過濾器（qì）（HEPA）用（yòng）於生產空間（jiān）空氣的處理和過濾的終端（duān）過濾器。無菌生產要求強製使用高效過濾器，而固體和（hé）半固體（tǐ）劑（jì）型的生產有時（shí）也會使用。H13至H14（DIN1822）是高效過濾器（qì）的（de）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.

製藥廠高效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（wén）件中，要求每年更換（huàn）過濾器，而不管檢（jiǎn）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（kě）以使（shǐ）用期限的具體數值。根據GMP的要求，過濾器不得有泄（xiè）漏，這需要通過確認和定期執行ISO14644-3中的泄漏測（cè）試，無菌車間（jiān）來說這是必須的。根（gēn）據附錄1（PIC/S PI032-2）的技術詮釋，A/B級每6個月進行（háng）泄（xiè）漏測試（shì），C/D級則為12個月。FDA無菌指南要求進行定期檢查。附錄1的要求在這裏也適用。泄（xiè）漏是可（kě）以修補的，但修補的麵積不能超過單個過濾器麵積的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（zhōu）靈潔淨化高效過濾器並不隻有完整性一件事情。過濾器（層）的負載以及上下遊壓差也很重要。如果過濾器（qì）上下遊壓差升高，則（zé）送排風係（xì）統的能量需求會（huì）增加，這（zhè）樣才能維持必須的換氣次數。這樣的過濾器上下遊壓差可能會增加通風係統的性能限製。為了保護高效過濾器，就（jiù）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（xì）過濾器。這些過濾器必須定期更換以保護高效過濾器避免堵（dǔ）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用期（qī）限直接取決於上下遊壓差。隻有在上下遊壓差達到一定數值影響到通風係統的性能，或者是能量（liàng）需（xū）求超過過濾器（qì）更換成本時，過濾器（qì）更換才有意義。但是，過濾器必須能通過泄漏測試（如（rú）上所述）。事實上，很多公司並（bìng）不會使用一個過濾器超過8年。正如前述，並沒有法規規定（dìng）這樣的值，這都隻是根據（jù）經驗得來的。

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（lǜ）器必須定期更換嗎？如（rú）不定期更（gèng）換，隻在空調驗證時（shí）更換風量不合格（gé）房間高效和撿漏不合格高效可以嗎（ma）？

CFDA審核查驗中心回複：你好，更換高效（xiào）過濾器根據空調（diào）驗證參考：時風量（liàng）和撿漏（lòu）是必須的，但同（tóng）時也應製定出具體高效過濾器最長使用周期，故（gù）還是應該有定期的（de）概（gài）念（niàn）。同時必（bì）須定期進行（háng）過濾器完整（zhěng）性測試（shì）。

製（zhì）藥廠高效過濾器一般多久更換？

潔淨區A級高效過濾器（qì）檢漏

谘詢內容：潔淨區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（biāo）準是多少。

CFDA審核查驗（yàn）中心回（huí）複：靈潔高效過濾器檢漏一般在非關鍵區（qū）域可以使用塵埃粒子計數器，但A級潔淨（jìng）區高（gāo）效過（guò）濾器不推薦使用塵（chén）埃粒子計數器掃描檢（jiǎn）漏