呂梁製藥廠（chǎng）高效過濾器

關於高效過濾器的（de）更換周期方麵的問題，很多潔淨室（shì）用戶都很關心，畢竟高效過濾器決定著潔淨室的潔淨度能否達到標（biāo）準，就在前方91小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，高效過濾器（HEPA）用於生產空（kōng）間空氣的處理（lǐ）和過濾的（de）終端過濾器。無菌生產要求強製使用高效過濾器（qì），而固體和半固體劑型的生（shēng）產有時（shí）也會使用。H13至H14（DIN1822）是高效過濾器（qì）的兩種，後者截留率為（wéi）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（yào）廠高效過濾器一般多久更（gèng）換？

91小视频經常看（kàn）到在（zài）公司內部文件中，要（yào）求每年更換過濾器（qì），而不管檢測結果如何。這是否合理？在相關（guān）的GMP指南（nán）中並沒有高效過濾器可以使用期限（xiàn）的具體數（shù）值。根據GMP的要求（qiú），過濾（lǜ）器不得有泄漏，這需（xū）要通過確認和定期執（zhí）行ISO14644-3中的泄漏測試，無菌車間來說這是必須的。根（gēn）據附錄1（PIC/S PI032-2）的技術詮釋，A/B級每6個月進行泄漏測試（shì），C/D級則為12個月。FDA無（wú）菌指南要求進行定期（qī）檢查（chá）。附錄1的（de）要求在這裏也（yě）適用。泄漏是可以修補的，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（xiào）過濾器（qì）並不隻有完整性一件事情。過濾器（層）的負載以（yǐ）及上下遊壓差（chà）也很重要。如果過濾（lǜ）器上下遊（yóu）壓差升高，則送排風係統的能量需求會增加（jiā），這樣才能（néng）維持（chí）必須的換氣次數（shù）。這（zhè）樣的過濾器上下遊壓差（chà）可能會增加通風係統（tǒng）的性能限製。為了保護高效過濾器，就要使（shǐ）用前端過濾器---通常（cháng）是（shì）像F7和F9過（guò）濾器（EN779）這樣的精細過濾器。這些過濾器必須定（dìng）期更換（huàn）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（kě）以說最長使用期限直接（jiē）取決於上下遊壓差。隻有在上下遊（yóu）壓差達到一定數值影響到通風係統的性能，或者是能量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（qì）必須能通過泄（xiè）漏測試（如上所述）。事實上，很多公司並不會使用一個過濾器超過8年（nián）。正如前述，並（bìng）沒有法規規定這樣的（de）值，這都隻是根（gēn）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（kōng）調係統的高效過濾器必須定（dìng）期（qī）更（gèng）換嗎（ma）？如不定期更換（huàn），隻在空調驗證時更換風量不合格房間高效和撿漏不合格高效可以嗎？

CFDA審核查驗中心回複：你好，更換高效過（guò）濾器根據空調驗（yàn）證參考：時風量和撿漏是必須的，但（dàn）同時也應製定出具體（tǐ）高效過濾器（qì）最長（zhǎng）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（shì）。

製藥廠高效過濾器一般多久更換？

潔淨區（qū）A級高效過（guò）濾器檢漏

谘（zī）詢內容：潔淨區（qū）A級高效（xiào）過濾器檢漏是否可以使（shǐ）用 塵埃粒子計數器 掃描（miáo）檢漏，如果可以，那（nà）麽判斷無泄漏的標準是多少。

CFDA審核查驗中心回複：靈（líng）潔高效（xiào）過濾器檢漏一般在非關鍵區域可以使用塵埃粒子計數器，但A級潔（jié）淨區高效過濾器不推（tuī）薦使用塵埃粒子計（jì）數器掃描檢漏