Qualification Services

Factory Acceptance Test (FAT)

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.

Site Acceptance Test (SAT)

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.

cGMP Qualification Package

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.

Installation Qualification and Operational Qualification (IQ/OQ)

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:

Cycle Development

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.

Performance Qualification (PQ)

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:

• A standard number of runs and set of tests
• PQ protocol with one round of edits
• On-site PQ protocol execution
• Empty chamber heat distribution study
• Heat penetration study
• Biological challenge study
• Final report including reports and data sheets from all tests, signed copies of PQ protocol and certificates of completion

PQ service can also be customized to meet your individual needs. Custom PQ service is available for:

• Steam sterilizers
• Washers
• Finn-Aqua multiple effect water stills
• Finn-Aqua pure steam generators

Performance Requalification Services

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.