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Our Services
Whether you're starting a new e-beam or x-ray sterilization operation or looking to strengthen an existing system, we're here to help.
System Integration
Key Services:
- Initial Discussion and Feasibility Study
- Solution Design
- Business Case Development
- Equipment Procurement
- Site Construction Coordination
- Final Testing and Validation
- ISO 13485 / ASTM / ISO 11137 Compliance
- Maintenance and Calibration
Quality Systems
Key Services:
- ISO 13485 / ISO 11137 Compliant Sterilization Procedures
- ISO / ASTM Compliant Test and Measurement Procedures
- Internal Quality Audits
- Supplier Quality Audits
- Workforce Training
- CAPA Process Implementation
Product Validation
Key Services:
- Product Packaging Evaluation and Optimization for Sterilization
- Dose Mapping
- Dose Audits
- Maximum Dose Validation
- Induced Radioactivity Evaluation
- Establishment of Product Release Criteria
- Family Groupings
Dosimetry Systems
Key Services:
- Application-Based Dosimetry System Evaluation and Selection
- ISO / ASTM Compliant Testing and Validation
- Dosimetry Room UV Exposure Assessment
- Dosimetry Equipment Calibration and Maintenance
- Dosimetry System Procedures
- Internal Audits
- Workforce Training
Radiation Safety
Key Services:
- Radiation Safety Assessment
- Compliant Safety Program Development
- Personnel Dose Monitoring Program
- Workplace Monitoring
- Calibration and Maintenance of Monitoring Equipment
- Branded Training Materials: We can
Our Services
Whether you're starting a new e-beam or x-ray sterilization operation, or looking to strengthen an existing system, we're here to help.
SYSTEM
INTEGRATION
Guided project development to meet customer needs.
Key Services:
- Initial Discussion and Feasibility Study
- Solution Design
- Business Case Development
- Equipment Procurement
- Site Construction Coordination
- Final Testing and Validation
- ISO 13485 / ASTM / ISO 11137 Compliance
- Maintenance and Calibration
QUAILTY
SYSTEMS
ISO 13485 / ISO 11137 / ASTM compliant procedures, audits, and testing.
Key Services:
- ISO 13485 / ISO 11137 Compliant Sterilization Procedures
- ISO / ASTM Compliant Test and Measurement Procedures
- Internal Quality Audits
- Supplier Quality Audits
- Workforce Training
- CAPA Process Implementation
PRODUCT
VALIDATION
Assisted dose mappings, family groupings, and package design.
Key Services:
- Product Packaging Evaluation and Optimization for Sterilization
- Dose Mapping
- Dose Audits
- Maximum Dose Validation
- Induced Radioactivity Evaluation
- Establishment of Product Release Criteria
- Family Groupings
DOSIMETRY
SYSTEMS
Application-based system selection and operation support.
Key Services:
- Application-Based Dosimetry System Evaluation and Selection
- ISO / ASTM Compliant Testing and Validation
- Dosimetry Room UV Exposure Assessment
- Dosimetry Equipment Calibration and Maintenance
- Dosimetry System Procedures
- Internal Audits
- Workforce Training
RADIATION
SAFETY
Safety program development and workforce training for compliance.
Key Services:
- Radiation Safety Assessment
- Compliant Safety Program Development
- Personnel Dose Monitoring Program
- Workplace Monitoring
- Calibration and Maintenance of Monitoring Equipment
- Branded Training Materials
Have a project in mind?
Let's get started.
We want to know your exact needs so that we can provide the perfect solution.
