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Complying with regulatory requirements is critical to your success. Qualification and validation services are documented and executed to your requirements by our global network of qualification specialists and can be customized 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 and tailored to meet your specific needs. By working with STERIS, you gain not only validation compliance directly from the OEM, but you also benefit from faster time to market.
Designed to ensure your equipment performs up to your standards, Factory Acceptance Tests verify that the equipment has been built to comply with your specific design qualifications. Performed on-site at our manufacturing facilities, FAT service combines a thorough inspection of the equipment with rigorous testing to ensure your expectations for operation are met.
Based on Factory Acceptance Testing, Site Acceptance Testing (SAT) provides you with documentation and assurance that your new equipment works to your specifications once inside your facility. The service includes a full NIST-traceable calibration and testing of alarms and aborts, cycle performance, installation and operational checks and more.
The cGMP Qualification Package is based on GAMP 5 and ASTM-E2500 guidelines and includes FAT, SAT and IQOQ documentation and execution in one comprehensive offering.
It begins at our factory during the FAT with extensive installation and operational checks. Tests including electrical configurations, utility supplies and adjustments and are designed to challenge your new unit in production-like conditions, ensuring it functions as intended.
Once your FAT protocols have been completed and approved, the unit is installed at your site and qualification continues with SAT and IQOQ testing. These tests can be completed in less time and have less variance because they leverage the extensive testing completed during the FAT.
Whether your equipment is newly installed or being relocated, IQOQ is a key element of your overall validation program. The service begins with an equipment-specific comprehensive document that is then executed onsite by a STERIS Field Service Representative.
Your service includes:
Optimize your equipment’s performance with STERIS cycle development services. Our expert team of qualification specialists will help you determine the combination of cycle parameters and load configurations best suited to your applications so you can maximize your equipment’s performance.
Ensure your equipment is functioning at peak performance with performance qualification services from STERIS. Our fundamental approach ensures that your specific application and equipment requirements are vital in developing your protocol.
Our standard PQ service is available for steam sterilizers and washers and includes:
PQ service can also be customized to meet your individual needs. Custom PQ service is available for:
Periodic requalification of your equipment keeps you in compliance and gives you assurance that your equipment meets your standards. STERIS requalification service includes on-site testing performed according to either Customer-provided or STERIS-written protocol.
When risk is not an option, trust STERIS to protect and maintain your equipment with one of our flexible service plans.
Boost the performance of your older equipment by upgrading key components with the latest technology.