Qualification Services
We execute our qualification and validation services to meet your requirements. Our global network of qualification specialists can customize these services to meet your individual needs. Based on current Good Manufacturing Practices (cGMPs) and Good Engineering Practices, our protocols and procedures are created to help you comply with validation requirements.
cGMP Qualification Package Service
This comprehensive service package streamlines validation by seamlessly integrating Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT) and Installation/Operational Qualification (IQ/OQ). Learn MoreCycle Development Service
Ideal for Customers who require specialized cycle programming, our qualification specialists collaborate with you to create custom cycle parameters and load configurations that match your specific operational requirements. Learn MoreFactory Acceptance Testing Service (FAT)
Through thorough inspection and rigorous testing, we ensure your equipment meets design specifications, operational requirements and validation standards before installation. Learn MoreInstallation Qualification (IQ) and Operational Qualification Service (OQ)
Our comprehensive approach ensures compliance while streamlining your validation program. Learn MorePerformance Qualification (PQ) and Requalification Services
Our comprehensive approach ensures your equipment consistently meets industry standards and your specific operational requirements.Learn MoreSite Acceptance Testing (SAT) Service
SAT validates performance after installation through rigorous testing at your facility. Learn MoreOptimal Performance with OEM Parts
Your equipment is crucial to your facility’s success. Keep it in top condition with STERIS OEM replacement parts. Our parts meet the highest quality standards and come with a 90-day warranty, ensuring compliance with maintenance regulations. With 24/7 service support and a comprehensive online catalog, finding the right part is simple.
Dedicated Scientific Support
Our technical services team, comprised of industry-recognized scientists and engineers, provides exceptional expertise in contamination control strategies, process optimization, regulatory compliance, validation support and quality assurance. Navigate complex regulatory landscapes, reduce operational risks and accelerate your time-to-market with support from our professionals.
Paul Lopolito
Paul has over two decades of industry experience in pharmaceutical manufacturing and laboratory research, specializing in process cleaning, cleaning validation and contamination control. At STERIS Life Sciences, he provides global technical support through field consultations, training and analytical testing and manages the PACE™ program.
Bruno Aze
Bruno Aze has over three decades of industry experience, specializing in Good Manufacturing Practices (GMP), biosafety research and contamination control technologies. At STERIS Life Sciences, he supports innovation in Vaporized Hydrogen Peroxide (VHP™) technology and aseptic processing.