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PROCÉDÉ POUR UN ENSEMBLE ASEPTIQUE D'UN DISPOSITIF MÉDICAL À COMPOSANTS MULTIPLES ET KIT CORRESPONDANT
专利权人:
Roche Diabetes Care GmbH;F. Hoffmann-La Roche AG
发明人:
申请号:
EP15195346.0
公开号:
EP3170523A1
申请日:
2015.11.19
申请国别(地区):
EP
年份:
2017
代理人:
摘要:
The invention concerns a method for an aseptic assembly of a multi-component medical device (60) comprising the steps of:- providing a first component (12) of the medical device (60) in a first container (10) and a second component (40) of the medical device (60) in a second container (38), wherein each of the separated containers (10,38) comprises a ruptureable portion (28,52),- sterilizing the first component (12) in the first container (10) using a first sterilization technique and sterilizing the second component (40) in the second container (38) using a second sterilization technique,- joining the first and second container (10,38) while arranging the ruptureable portions (28,52) in an overlapping configuration which is aseptically sealed against the surroundings,- transferring one of the components through the ruptureable portions (28,52) and aseptically assembling the components to form the medical device (60) as a sterile package.
来源网站:
中国工程科技知识中心
来源网址:
http://www.ckcest.cn/home/

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