來賓製藥（yào）廠高效過濾器

關於高效過濾器的更換周期方麵的問（wèn）題，很（hěn）多潔（jié）淨室用戶都很關心，畢竟高效過濾器決定著潔淨室的（de）潔淨度能否達到（dào）標準（zhǔn），就（jiù）在前（qián）方我（wǒ）們也整理過相關方麵的問（wèn）題：高效過濾器的更換標（biāo）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（zài）製藥行業，高效過濾（lǜ）器（HEPA）用於生產空間（jiān）空氣的（de）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有時也會使用。H13至H14（DIN1822）是高（gāo）效（xiào）過濾器的兩種，後者截留率為99.995%。但多久必須（xū）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（yī）般多久更換？

91小视频經常看（kàn）到在公司內（nèi）部文件中，要求每年更換過濾器，而不管檢測結果如何。這是否合（hé）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，過濾器不得有泄漏，這需要通過確認和（hé）定期執行ISO14644-3中的泄漏測（cè）試，無菌車間來說這是必須的（de）。根據附錄1（PIC/S PI032-2）的技術詮釋，A/B級每6個月進行泄漏測試，C/D級則為12個月。FDA無菌（jun1）指南要求進行定（dìng）期檢查。附錄1的要（yào）求在這裏也適用。泄漏是可以修補的，但（dàn）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（dāng）然，廣州靈潔（jié）淨化高效（xiào）過濾器並不隻有完（wán）整性一件事情。過濾器（層（céng））的（de）負載以（yǐ）及上下遊（yóu）壓（yā）差也（yě）很重要。如（rú）果過濾器上下（xià）遊壓（yā）差升高，則送排風係統的能量需求會增加（jiā），這樣才能維持必須的（de）換氣（qì）次數。這樣的過濾器上（shàng）下遊壓差可能會增加通風係統的（de）性能限製。為了保護高效過濾（lǜ）器，就要使用前端過濾（lǜ）器---通（tōng）常是（shì）像F7和F9過濾（lǜ）器（EN779）這樣的精細過濾器（qì）。這些過濾器必須定期更換（huàn）以保護高效過（guò）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（jiàn）角度來看，91小视频可以說最長使用期限直接取決於上下（xià）遊壓差。隻有在上下遊（yóu）壓差達（dá）到一定數（shù）值（zhí）影響到通風係（xì）統的性能，或者是能量（liàng）需求超過過濾器更換成本時，過濾器更換才有意義。但是，過濾器必須能通過泄漏測試（如上所（suǒ）述）。事實上，很多公司並不會使（shǐ）用一個過濾器超過8年。正如前述，並（bìng）沒有法規規定這（zhè）樣的值，這都隻是（shì）根據經驗得來的。

靈潔高效過濾器更換問題

谘詢內容：老師您好，小容量注射劑車間空調係統的（de）高效過濾器必（bì）須定期更（gèng）換嗎？如不定期更換，隻在空調驗證時更（gèng）換風量（liàng）不合格房間高效和撿漏不合格（gé）高效可以嗎？

CFDA審核查驗中心回複：你好，更換高效過濾（lǜ）器根據空調驗證參考：時（shí）風量和（hé）撿漏（lòu）是必須的，但同時也應製定出具體高效過濾器（qì）最長（zhǎng）使用周期，故（gù）還是應該有定期的概（gài）念。同時必須定期進行過（guò）濾器完整性測試（shì）。

製藥（yào）廠高效過濾器一般多久更換？

潔淨區A級高效過濾器檢（jiǎn）漏

谘詢內（nèi）容：潔淨區（qū）A級（jí）高效過濾器檢（jiǎn）漏（lòu）是否可以使用 塵埃粒子（zǐ）計數器 掃描檢漏，如果可以，那麽判斷（duàn）無（wú）泄（xiè）漏的（de）標準是多少。

CFDA審核查驗中心回（huí）複：靈潔高效過濾（lǜ）器檢漏一般在非關鍵區（qū）域可以使用塵（chén）埃粒子計數器，但A級潔淨區高效過濾器（qì）不推薦使用（yòng）塵埃粒子計數（shù）器掃描檢漏