Steam Process Validation/Qualification

Steam Process Validation/Qualification

Steam sterilization is the primary method used to sterilize pharmaceutical manufacturing equipment, containers, and final products. Validating this process to GMP requirements is non-negotiable for any pharmaceutical facility seeking regulatory approval.

IETQAN’s Steam Process Validation and Qualification services are conducted in accordance with ISO 17665, EN 285, and EU GMP Annex 1 requirements, covering the complete IQ/OQ/PQ validation lifecycle. Our thermometric survey methodology ensures comprehensive heat distribution and heat penetration data is gathered for all critical load configurations, and our reports are structured for direct use in regulatory submissions to national and international authorities.