journal of global biosciences issn 2320 1355 volume 8 number 1 2019 pp 5739 5759 website www mutagens co in research paper guidance for periodic qualification of steam sterilizer used ...
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...Journal of global biosciences issn volume number pp website www mutagens co in research paper guidance for periodic qualification steam sterilizer used the sterile pharmaceutical industry tushar kanti mondal mylan laboratory ltd injectable division member corporate validation group india abstract sterilization to sterilize items that can withstand moisture and high temperature an autoclave or is surgical equipment instruments other materials mandatory all machines biological biomedical industries purpose requalification verify performance with respect time autoclaving most effective efficient means autoclaves operate on a relationship these two variables are extremely important need establish through required challenge pre established during life cycle divided into parts first part physical verification critical operational control checks second evaluation step assure state deals output heat penetration study performed worst load mapped external sensors mapping thermal effect articles ...