聊城製(zhì)藥廠高效過濾器
所屬分類:聊城高效過濾器
- 點(diǎn)擊次數:
- 發布日期:2020/11/26
- 在線(xiàn)詢價
關於高效過濾器的更(gèng)換(huàn)周期方麵的問題,很多潔淨室用戶都很關心,畢(bì)竟高效過濾器決定著潔淨(jìng)室的(de)潔淨度能否達到標準,就在前方91小视频也整理過相關方麵的問(wèn)題:高(gāo)效(xiào)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(zhì)藥行(háng)業,高效(xiào)過(guò)濾器(HEPA)用於生產空間空氣的處理和過濾的終端過濾器。無(wú)菌生產要求強製使用高效過濾器,而固體和半固體劑型的(de)生產有時也會使用。H13至H14(DIN1822)是(shì)高效過濾器的(de)兩種,後者截留率為99.995%。但(dàn)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(jiǔ)更(gèng)換?
91小视频經常看到在公司內部文件中,要求每年更換過濾器,而不管檢測結果如何。這是否合理?在相關的GMP指南中並沒有高效過濾器可(kě)以使用期限的具體數值。根(gēn)據GMP的要求,過濾器不得有泄漏,這需要(yào)通過確認和定期執行ISO14644-3中的泄漏測試,無菌車間來說這是必須的。根據附錄1(PIC/S PI032-2)的技術詮釋,A/B級每6個月進行泄(xiè)漏測試,C/D級則為12個月(yuè)。FDA無菌(jun1)指南要求進行(háng)定期檢查(chá)。附錄1的要求在這裏也適用。泄漏是(shì)可以修補(bǔ)的,但修補的麵積不(bú)能超過單個過濾器麵積的(de)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(zǎi)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(cái)能維持必須的換氣次數。這樣的過(guò)濾器上下遊壓(yā)差可能會增加通風(fēng)係統的性能限(xiàn)製。為了保護高效過濾器,就要使用前端過濾器---通常是像F7和F9過(guò)濾器(EN779)這樣的精細過濾器。這些過濾器必須定期更換以保護高(gāo)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(jiǎo)度來看,91小视频(men)可以說最長使用(yòng)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(de)性能,或者是(shì)能量需求超過過濾器更換成本時,過濾器更換才(cái)有意義。但是,過(guò)濾器必須能通過泄漏測試(如上所述)。事實上,很多公司並不會使用一個(gè)過濾器超過8年。正如前述,並沒有法規規定這樣的值,這都(dōu)隻是根據經驗(yàn)得來(lái)的。
靈潔高效(xiào)過(guò)濾器更換問題(tí)
谘詢內容:老師您(nín)好,小容量注射劑車間空調係(xì)統的高效過濾器必須定期更(gèng)換嗎?如不定期更換,隻在(zài)空調驗證時更換風量不合格房間高效和撿漏不合(hé)格高效可以嗎?
CFDA審核(hé)查驗中心回複:你好,更換高效過濾器根據空調驗(yàn)證參(cān)考:時風量和撿漏是必(bì)須的,但同時也(yě)應製定出具體高效過濾器(qì)最長使用周期,故(gù)還是(shì)應該有定期的概念。同時必須定期進行過濾器完整性測試。
製藥(yào)廠(chǎng)高效過濾器一(yī)般多久更換?
潔(jié)淨區A級高效過濾器檢漏
谘詢內容:潔淨(jìng)區A級高效過濾器檢漏是否(fǒu)可以使用 塵埃粒子計數器 掃描檢漏,如果可以(yǐ),那麽判(pàn)斷無泄漏(lòu)的標準是多(duō)少。
CFDA審核(hé)查驗中心回複:靈潔高效過濾器檢漏一般在非關鍵區域可以使用塵埃粒子計數(shù)器,但A級潔淨區高效過濾器不推薦使用塵(chén)埃粒子計數器掃描檢漏