Beyond Media Fills: Building a Contamination Control Strategy That Withstands Regulatory Scrutiny

Abstract

A passed media fill shows that an aseptic process can run successfully during a test, but it does not prove ongoing sterility assurance. This paper outlines a connected, risk-based contamination control strategy (CCS) spanning facility design, utilities, equipment, personnel flow, cleaning and disinfection, environmental monitoring, validation and the quality system. It argues that media fills are one verification tool within a continuously improved CCS that prevents, detects and responds to contamination risks.