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<1116> MICROBIOLOGICAL EVALUATION OF CLEAN ROOMS AND
OTHER CONTROLLED ENVIRONMENTS (美国药典 28版)
洁净室和其他受控环境的微生物检测
The purpose of this informational chapter is to review the various issues that relate to
aseptic processing of bulk drug substances, dosage forms, and in certain cases,
medical devices; and to the establishment, maintenance, and control of the
microbiological quality of controlled