Steam, Dry Heat & Radiation Sterilization: Validating Sterilization Methods in Aseptic Environments Validating Steam, Dry Heat & Radiation Sterilization in Aseptic Pharma Environments Sterilization is one of the most critical processes in aseptic pharmaceutical manufacturing. Whether using steam, dry heat, or radiation, the sterilization method must be validated rigorously to ensure the consistent inactivation of microorganisms, including bacterial spores. This article provides an in-depth guide to validating sterilization processes in compliance with global regulatory expectations such as FDA Aseptic Processing Guidance, EU GMP Annex 1, and ICH Q8–Q10. 1. Regulatory Basis for Sterilization Validation According to EMA Annex 1 and…