Validating Microbial Hold Time and Media Fill in Aseptic Processing: A Regulatory-Compliant Guide How to Validate Microbial Hold Time and Media Fill in Aseptic Processing Introduction In sterile manufacturing, validating microbial hold times and media fills is critical to ensure aseptic integrity throughout processing. Hold time studies assess microbial contamination risk during pauses in manufacturing, while media fill simulations verify aseptic techniques under worst-case conditions. These validations are essential components of a robust contamination control strategy and a requirement under FDA, EMA, and WHO aseptic processing guidelines. Applicable Guidelines FDA: Guidance for Industry – Sterile Drug Products Produced by Aseptic…