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空氣過濾器

襄陽製藥廠高(gāo)效過濾器

  • 所屬分類(lèi):襄陽高效過濾器

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  • 發布日期:2020/11/26
  • 在線詢價
詳細介紹

關於高效過濾器的(de)更換周期方麵的問題,很多潔淨室用戶都很關心,畢竟高(gāo)效過濾器決定著潔淨室的(de)潔(jié)淨度能否(fǒu)達(dá)到標準(zhǔn),就在前方91小视频也整理過相關方(fāng)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?

在製藥行業,高效(xiào)過濾器(HEPA)用於生(shēng)產空間空氣的處(chù)理和過濾(lǜ)的終端過濾器。無菌生(shēng)產要求強製使用高效過濾器,而固體和(hé)半固體(tǐ)劑型的生產有時也會使用。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(huàn)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?

91小视频經常看到在公司內部文件中,要(yào)求每年(nián)更換過濾器,而不管檢測結果如何。這是否合理?在相(xiàng)關(guān)的(de)GMP指南中並沒有高效過濾器可以使用期限的具體數(shù)值。根據GMP的要求(qiú),過濾器不得有泄漏,這需要通過確認和定期執行ISO14644-3中的泄漏測試,無菌車間來說這(zhè)是必須的。根據附錄1(PIC/S PI032-2)的(de)技術詮釋,A/B級每(měi)6個月進行泄漏測試,C/D級則為12個月。FDA無菌指南要求進行定期檢(jiǎn)查。附(fù)錄1的要求在這裏也適(shì)用。泄(xiè)漏是可以(yǐ)修補的,但修補的麵積(jī)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(guǎng)州靈潔淨化高效過濾器並(bìng)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。如果過濾器上下遊壓差升高,則送排風係統的能量需求會增加,這樣才能維持必須的換氣次數(shù)。這樣的過(guò)濾器上下遊壓差(chà)可(kě)能會增加(jiā)通風係統的性能限製(zhì)。為了保護高效過(guò)濾器,就要使用前端過濾器---通常是像F7和(hé)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(lǜ)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小视频可以說最長使用期限直接取決於上下遊壓差。隻有在上(shàng)下遊壓差達到一定數值影響到通風係統的性能,或者是能量需求超(chāo)過過濾器更換(huàn)成本時,過(guò)濾器更換才有意(yì)義。但是,過濾器必須能通過泄漏測試(如上所(suǒ)述)。事實(shí)上,很多公司並不會使用一個過濾器超過8年。正如前(qián)述,並沒有法規規定這樣(yàng)的值,這都隻是(shì)根據經驗得來的。

靈潔(jié)高效過濾器更換問題

谘詢內容:老師(shī)您(nín)好,小容量(liàng)注射劑車間空調(diào)係統的高效過濾器必須定(dìng)期更換嗎?如不(bú)定期更換,隻在空調驗證時更換風量不合格房間高(gāo)效和撿漏不合格高效可以嗎?

CFDA審核查驗中心回(huí)複:你好,更換高效(xiào)過濾器根據空調驗證參考:時風量和撿漏是必須的,但同(tóng)時也應製定出具體高(gāo)效過濾器最長使用周(zhōu)期,故還是應該(gāi)有定期(qī)的概念。同時必須(xū)定期進行過濾器完(wán)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(xiào)過濾器檢漏

谘詢內(nèi)容:潔淨區A級高效過濾器檢漏是否可(kě)以使(shǐ)用 塵埃粒子計數器 掃描檢漏,如果可以,那(nà)麽判(pàn)斷無泄漏的標準是多少。

CFDA審核查驗中心回複(fù):靈潔高效過濾器檢漏一(yī)般在非(fēi)關鍵區域可以使用塵埃粒子計數器,但A級潔淨區高效過濾器不推薦使用塵埃粒子計數器掃描檢漏(lòu)


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