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doi: 10.1007/978-1-4684-7971-3_48

The discipline of identifying and measuring security risks associated with an IS, and controlling and reducing those risks to an acceptable level

Aseptic Preparation and Storage: Principles for Clinical Trial Settings Reconstitution of injectable investigational products must be performed by trained personnel following the trial protocol, using the specified diluent, in an appropriate aseptic environment

Alcohol needs contact time to sterilize effectively
