Liquids

This article outlines a comprehensive approach for organizing a firm’s aseptic operations, including planning for routine and nonroutine interventions, establishing effective process simulations,and determining which vials to incubate. Performing an aseptic process almost always requires operators to manipulate sterile or sterilized products and components. These activities are universally considered to offer the greatest potential for introducing microbial contamination (1–4). That potential has been recognized by the US Food and Drug Administration inspectors and has led to some substantial concerns raised in warning letters issued in 2000 (5–6). The measures taken to respond to these concerns by the companies involved have implications for other firms performing aseptic processing.