初效過濾器、中效過濾器、高效過(guò)濾器、淨化設備(bèi)專業生產廠家(國家技術企業)歡迎您!

服務熱(rè)線:4008-727374

空氣過濾(lǜ)器

汕尾製藥廠高效過(guò)濾器

  • 所屬分類:汕尾高效過(guò)濾器

  • 點(diǎn)擊次數(shù):
  • 發布日期:2020/11/26
  • 在(zài)線詢價
詳細介(jiè)紹

關於高效過濾(lǜ)器的更換周期方麵(miàn)的問題,很多(duō)潔淨室(shì)用戶都很關心,畢竟高效過濾器決定(dìng)著(zhe)潔淨室的潔淨度能否達到(dào)標準(zhǔn),就在前方91小视频也整(zhěng)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(yè),高效過濾器(HEPA)用於生產空間空氣的處(chù)理和過濾的終端過濾(lǜ)器。無菌生產(chǎn)要求(qiú)強製使用高效過(guò)濾器(qì),而固體和半固體(tǐ)劑型的生產有時也會使用。H13至H14(DIN1822)是高效過濾(lǜ)器的兩種,後者(zhě)截留(liú)率為99.995%。但多(duō)久必須更換一次(cì)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(jiǔ)更換?

91小视频(men)經常看到在公司內部文件中,要求每年更換過濾(lǜ)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使用期限的具體數值。根據(jù)GMP的要求,過濾器不得有泄漏,這需要通過確認和定(dìng)期執行ISO14644-3中的泄漏測(cè)試,無菌車間(jiān)來說這是必(bì)須的。根據附錄1(PIC/S PI032-2)的技術詮釋,A/B級每6個(gè)月進行泄漏測試,C/D級則為12個月。FDA無菌指(zhǐ)南要求進行定期檢查。附錄1的要求在這裏也(yě)適用。泄漏是可以修補的(de),但(dàn)修補的麵(miàn)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,廣州靈潔淨(jìng)化高效過濾器並不隻有完整性一(yī)件事情。過濾(lǜ)器(層)的(de)負載以及上下遊壓差也很(hěn)重要。如果過(guò)濾器上下遊壓差升高,則送排風(fēng)係統的能量需求會增加,這樣才能維持必須的換氣次數。這樣(yàng)的過濾器上(shàng)下遊壓差(chà)可能會增加通風係統的性能限製。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過濾器(EN779)這(zhè)樣的精細過濾器。這些過濾器必須定期更換以(yǐ)保護(hù)高效過濾器(qì)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(dù)來看(kàn),我(wǒ)們可以說最長使用期限直接(jiē)取決於上下遊壓差。隻有(yǒu)在(zài)上下遊壓差達(dá)到一定數值影響到通風係統的性能,或者是能量需(xū)求超過過濾器更換成本時,過(guò)濾器更換才有意義。但是,過濾(lǜ)器必須能通過(guò)泄漏測試(如上所(suǒ)述)。事(shì)實上,很多公司並不會使用(yòng)一個過濾器超過8年。正如前述,並沒有法(fǎ)規規定這樣的值,這都隻是根(gēn)據經驗得來的。

靈潔高效過(guò)濾器(qì)更換問題

谘詢內(nèi)容:老師您好,小容(róng)量注射劑車間空調係統的高效過濾器必(bì)須定期更換嗎?如不定(dìng)期(qī)更換,隻在空調驗證時更換風量不合格房間(jiān)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(gāo)效過濾器根據空(kōng)調驗證參考:時風量和撿(jiǎn)漏是必須(xū)的,但(dàn)同時也應(yīng)製定出具體高效過濾器最長使用周(zhōu)期,故還是應該有定期的概念。同(tóng)時必須(xū)定期進行過濾器完整性測試。

製藥廠(chǎng)高效過(guò)濾(lǜ)器一般多久更換?

潔淨區(qū)A級高效過濾器檢漏

谘詢內(nèi)容:潔淨區A級高效過(guò)濾(lǜ)器檢漏是否可以使用 塵埃粒子計(jì)數器(qì) 掃描檢漏,如(rú)果可以,那麽判斷無泄漏的標準是多(duō)少。

CFDA審核查驗中心回複:靈潔高效過(guò)濾器檢漏一般在非關鍵區域(yù)可以使用塵埃(āi)粒子計數器,但A級潔淨區高效過濾器不推薦(jiàn)使用塵埃粒子計數器掃(sǎo)描檢漏


本文網址:http://www.bzlsyt.com/product/645.html

關鍵詞:藥廠高效過濾器(qì),製藥高效過濾器,潔淨室高效過濾器

最近瀏覽:

在線留言
您的(de)姓名:
您的電話:
留言(yán)內容:
聯係(xì)91小视频

聯  係 人:袁經理

電      話:13829746856

傳(chuán)      真:020-84550845

郵      編:510000

網      址:www.bzlsyt.com

郵      箱(xiāng):fengzhe@gdlingjie.com 

地      址:廣東省廣州市番禺區石基鎮進(jìn)盈工業園(yuán)A區E座(zuò)



二維碼

1758957205702124.png

Copyright 2018,廣州靈(líng)潔空氣淨化設備官(guān)方網(wǎng)站(zhàn)版權所有   備案號:粵ICP備12000047號-6   技術支持:廣州靈潔

  • 在線客服
  • 聯係電話
    13829746856
  • 在線留言
  • 手機網(wǎng)站
  • 在線谘詢(xún)
    歡迎給91小视频留言
    請在此輸入留言內容,我(wǒ)們會(huì)盡快(kuài)與您聯係。
    姓名
    聯係人
    電話
    座機/手機(jī)號碼
    郵箱
    郵箱(xiāng)
    地址
    地(dì)址
    91小视频-91成人版-91视频免费下载-91成人网站