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Aseptic / sterile - “ A state of control attained by using an aseptic work area and performing activities in a manner that precludes microbiological contamination of the exposed sterile product” Validation of aseptic process should be designed to provide assurance through appropriate testing that all phases and activities of the process remain sterile and it is controlled within the predetermined parameters. Drug product, container, and closure are subject to sterilization separately, and then brought together.
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