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Our Services
We offer a comprehensive suite of services designed to ensure your e-beam or x-ray processing facility operates at peak efficiency, meets all regulatory requirements, and delivers the highest quality outcomes. Whether you are starting a new venture or optimizing an existing one, our experts are here to guide you.
Qualification Testing
Key Services:
- ISO 13485 / ASTM / ISO 11137 compliant e-beam and x-ray system IQ and OQ testing
- Site acceptance testing and irradiator characterization
- Critical parameter testing
(scan width, beam energy, beam current) - Conveyance system testing
(conveyor speed and tracking) - System dose mapping
(dose uniformity, process interruptions) - Performance qualification, including dose mapping for routine production and precision dose testing.
- Procedures for maintenance, calibration, and requalification
Dosimetry Systems
Key Services:
- Application-Based System Evaluation and Selection
- ISO/ASTM Compliant Testing and Validation
- IQ/OQ/PQ Qualification Services
- Dosimetry Calibration
- Dosimetry Response Testing
- Dosimetry Room UV Exposure Assessment
- Incubator Temperature Response Testing
- Equipment Calibration and Maintenance
- System Procedures Development
Process Control
Key Services:
- Guidance on Critical Process Parameters
- Establish Process Target Doses
- Routine Monitoring and Control Procedures
- Data Analysis and Interpretation
- Statistical Process Control (SPC)
- Deviation and Investigation Procedures
- Process Interruption Management
- Change Assessment and Control
- Documentation and Record Keeping
QMS Support
Key Services:
- Development of ISO/ASTM Compliant Procedures
- ISO/ASTM Compliant Testing and Validation
- ISO/ASTM Compliant Dosimetry Procedures
- Internal Quality Audits
- Supplier Quality Audits
- Workforce Training
- CAPA Process
System Selection
Key Services:
- Initial Discussion and Feasibility Study
- Solution Options
- Business Case and ROI
- Procurement and Integration Support
Radiation Safety
Key Services:
- Radiation Safety Assessment
- Development of IAEA Compliant Safety Program
- Personnel Dose Monitoring Program
- Workplace Monitoring
Our Services
We offer a comprehensive suite of services designed to ensure your e-beam or x-ray processing facility operates at peak efficiency, meets all regulatory requirements, and delivers the highest quality outcomes. Whether you are starting a new venture or optimizing an existing one, our experts are here to guide you.
Qualification Testing
Key Services:
- ISO 13485 / ASTM / ISO 11137 compliant e-beam and x-ray system IQ and OQ testing
- Site acceptance testing and irradiator characterization
- Critical parameter testing
(scan width, beam energy, beam current) - Conveyance system testing
(conveyor speed and tracking) - System dose mapping
(dose uniformity, process interruptions) - Performance qualification, including dose mapping for routine production and precision dose testing.
- Procedures for maintenance, calibration, and requalification
DOSIMETRY
SYSTEMS
Key Services:
- Application-Based System Evaluation and Selection
- ISO/ASTM Compliant Testing and Validation
- IQ/OQ/PQ Qualification Services
- Dosimetry Calibration
- Dosimetry Response Testing
- Dosimetry Room UV Exposure Assessment
- Incubator Temperature Response Testing
- Equipment Calibration and Maintenance
- System Procedures Development
Process Control
Key Services:
- Guidance on Critical Process Parameters
- Establish Process Target Doses
- Routine Monitoring and Control Procedures
- Data Analysis and Interpretation
- Statistical Process Control (SPC)
- Deviation and Investigation Procedures
- Process Interruption Management
- Change Assessment and Control
- Documentation and Record Keeping
QMS
Support
Key Services:
- Development of ISO/ASTM Compliant Procedures
- ISO/ASTM Compliant Testing and Validation
- ISO/ASTM Compliant Dosimetry Procedures
- Internal Quality Audits
- Supplier Quality Audits
- Workforce Training
- CAPA Process
System
Selection
Key Services:
- Initial Discussion and Feasibility Study
- Solution Options
- Business Case and ROI
- Procurement and Integration Support
RADIATION
SAFETY
Key Services:
- Radiation Safety Assessment
- Development of IAEA Compliant Safety Program
- Personnel Dose Monitoring Program
- Workplace Monitoring