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.
| Category |
Qualifying STERIS Products |
| VHP |
|
| Washers |
|
| Sterilizers and Chambers |
|
| Water Systems |
|
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:
| Step 1: General Information |
Step 2: Installation Qualification |
- Outline of the test plan
- Instructions and identification of testing personnel
- Prerequisite information
|
- Verification of the physical characteristics of the equipment
- Confirmation of proper equipment installation
- NIST-traceable calibration
|
| Step 3: Operational Qualification |
Step 4: Final Report |
- Rigorous testing to validate the operation of the equipment
- Including cycle verification, inputs, outputs, alarms and aborts testing, and more
|
- Signed IQ and OQ certificates of completion
- The final IQOQ document
- Executed IQOQ test procedure with corresponding print tapes for your review and approval
- Calibration report and equipment-specific technical data
|
| General Information |
- Outline of the test plan, including instructions and identification of testing personnel
- Prerequisite information
|
| Installation Qualification |
- Verification of the physical characteristics of the equipment, including mechanical and electrical components
- Confirmation of proper equipment installation
- NIST-traceable calibration
|
| Operational Qualification |
- Rigorous testing to validate the operation of the equipment, including cycle verification, inputs, outputs, alarms and aborts testing, and more
|
| Final Report |
- Signed IQ and OQ certificates of completion
- The final IQOQ document
- Executed IQOQ test procedure with corresponding print tapes for your review and approval
- Calibration report and equipment-specific technical data
|
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.