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KMID : 0369820090390040263
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Jorunal of Korean Pharmaceutical Sciences
2009 Volume.39 No. 4 p.263 ~ p.267
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Cleaning Validation Studies for Multi-Purpose Facility : Vial Filling Machine
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Yang Ho-Joon
Yong Chul-Soon
Choi Han-Gon
Sung Jun-Ho
Hwang Ma-Ro
Kim Jong-Oh
Kim Young-Ran
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Abstract
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The purpose of this study is to evaluate the efficacy of stipulated cleaning process, and the prohibition of cross-contamination and microbiological contamination, which inadequate cleaning in multi-production could occur, through cleaning validation of multi-purpose facility used to produce five biopharmaceutical products as sterile injection. After production of five biopharmaceutical products such as hGH, rhGCSF, rhEPO, rhFSH and rhIFN using vial filling machine, the cleaning validation such as residual analysis of active ingredients or human serum albumin, measurement of total organic carbon (TOC), residual analysis of detergent and microbiological contamination were carried out. In the case of rhGH and rhGCSF clean validations, drug residues were not detected. Furthermore, in the case of rhEPO, rhFSH and rhIFN clean validations, human serum albumin residues were not detected. At TOC (total organic carbon) analysis, all clean validations gave the TOC of about average 137.93%, not more than 150% of acceptance criteria. At sodium analysis for the checking of residues of cleaning agent, sodium residues were not detected. In sterility test, they showed no microbiological contamination of bacteria and fungi. Thus, this cleaning validation was determined as successful in protection of cross-contamination and induction of safety in multi-purpose facility.
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KEYWORD
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Clean validation, human serum albumin, total organic carbon, sterility, sodium analysis
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