潮州製藥廠高效過濾器（qì）

關於高效過（guò）濾器的更換周期方麵的問題（tí），很多潔淨室（shì）用戶都很關心，畢竟高效（xiào）過濾器決定著潔淨室（shì）的潔淨度能否達到標準，就在前方（fāng）91小视频也整理過相關方麵的問題：高效過（guò）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?

在製藥行業，高效過濾器（HEPA）用於生產空間（jiān）空（kōng）氣的處理和過濾（lǜ）的終端（duān）過濾器。無菌生產要求（qiú）強（qiáng）製使用高效過濾器，而固體和半固體劑型的生（shēng）產有時也會使用。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（yī）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（yào）廠高效過濾器一般多久更換？

91小视频經常看到（dào）在公司內部文件中，要求每年更換（huàn）過濾器，而不管檢測結果如何。這是否合理？在相關的GMP指南中並沒有高效過濾器可以（yǐ）使用期限的具體數值。根據GMP的要求，過濾器（qì）不得有泄漏（lòu），這需（xū）要通過確認（rèn）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。根據附錄1（PIC/S PI032-2）的技術（shù）詮釋，A/B級每6個月進行泄漏（lòu）測試，C/D級（jí）則為12個月。FDA無（wú）菌指南要求進行定期檢查。附錄1的要求在這裏也適用。泄漏是可以修（xiū）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，廣州靈（líng）潔淨化（huà）高效過（guò）濾器（qì）並不隻有完整性一件事情（qíng）。過濾器（層）的負載以及（jí）上下遊壓差也很重要。如果過濾器上下遊壓差升高，則（zé）送排風係統（tǒng）的能（néng）量需求會（huì）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（jiā）通風係統的性能限（xiàn）製。為了保護高效過濾器，就要使用前（qián）端過濾（lǜ）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.

從實踐角度來看，91小视频可以說（shuō）最長（zhǎng）使用期限（xiàn）直接（jiē）取決於上下遊壓差。隻（zhī）有在上下遊壓差達到一定數值影響到通風係統的性能（néng），或者（zhě）是能量需求超（chāo）過過濾器更換成本時，過濾器更換才有意義（yì）。但是，過濾器必須（xū）能通過泄漏測試（如上所述）。事實上，很多公司並不會使用一個過濾（lǜ）器超過8年。正如前述，並沒有法規規定這樣的值，這都（dōu）隻是（shì）根（gēn）據經驗得來的。

靈（líng）潔高效過濾器更換問題（tí）

谘詢內容：老師您好，小容量注射劑車間空調係統的高效過濾器必須（xū）定期更換嗎？如不（bú）定期更換，隻在空調（diào）驗證時更（gèng）換風量不合格房間高效（xiào）和撿漏不合格（gé）高效可以嗎？

CFDA審（shěn）核（hé）查驗中心回（huí）複：你好，更換高（gāo）效過濾器根據空調驗證參考：時風量和（hé）撿漏是必須的，但同時（shí）也應製定出具（jù）體高效過濾器最長使用周期，故還是應該有（yǒu）定期的（de）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（huàn）？

潔淨區A級高效過（guò）濾器檢（jiǎn）漏

谘詢內容：潔淨區A級（jí）高效（xiào）過濾器檢漏是否可以使用 塵埃粒子計數器 掃描（miáo）檢漏，如果可以，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（zài）非關鍵區域可（kě）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（jiàn）使用塵埃粒子計數器掃描檢漏