Washer & Sterilizer Equipment Validation
Washer & Sterilizer Equipment Validation
Washer & Sterilizer Equipment Validation How to Validate Washers and Sterilizers in Pharma: Protocols, Controls & Regulatory Focus Introduction In pharmaceutical manufacturing, washers and sterilizers are critical equipment for ensuring contamination control and aseptic assurance. Their validation is a regulatory requirement and must confirm that they perform reliably, reproducibly, and within pre-defined acceptance criteria. This article outlines a step-by-step, risk-based validation strategy for washers (CIP, COP, automated systems) and sterilizers (moist heat autoclaves, dry heat ovens, and chemical vapor systems) in accordance with GMP and global regulatory expectations. Regulators such as the FDA, EMA, and WHO emphasize equipment qualification, cleaning…