Validating Aseptic Technique & Operator Qualification: Media Fill, Gowning, Observation & Requalification How to Validate Aseptic Technique and Qualify Operators: A Complete Guide for Cleanroom Compliance Operators are the greatest source of contamination risk in aseptic processing. Regulatory agencies such as the FDA and EMA emphasize the need for stringent aseptic technique validation and ongoing qualification of all personnel working in Grade A and B environments. This article outlines the validation of aseptic technique and qualification of operators using gowning assessments, media fill trials, visual observations, and requalification protocols in line with global GMP expectations. 1. Regulatory Requirements for Aseptic…