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Qualification Testing
Comprehensive validation for optimal performance.
Comprehensive System Integration for Radiation Processing
Quantum EBX offers a comprehensive suite of system integration services to streamline your radiation processing operations, ensuring optimal performance from planning to implementation.
Our specialists will guide you through every essential step, from product feasibility assessment to final testing and validation.
Start Your Operation Quickly and Effectively
We provide comprehensive qualification testing services for E-beam and X-ray systems. Our irradiator qualification services ensure peak performance and compliance by providing expert guidance and hands-on support.
Our product validation services are tailored to your sterilization needs. We will guide you through bioburden and maximum dose determination, dose mapping, and dose setting to ensure products are sterile and compliant with regulations and standards.
System Testing and Validation
- ISO 13485 / ASTM / ISO 11137 Compliant E-beam and X-Ray system IQ and OQ testing
- Installation Qualification (IQ): Verification that the system is installed according to specifications.
- Operational Qualification (OQ):
Verification that the system operates within specified limits under anticipated operating ranges.
- Site acceptance testing and irradiator characterization
- Testing conducted at the client's site to ensure the system meets agreed-upon specifications.
- Characterizing the irradiator's performance parameters (energy, beam current, scan width).
- Critical parameter testing (scan width, beam energy, beam current)
- Detailed testing of key system parameters that influence dose delivery and uniformity.
- Ensuring these parameters are consistent and within validated ranges.
- Conveyance system testing (conveyor speed and tracking)
- Testing of the system that moves products through the irradiation field.
- Verifying consistent speed and accurate tracking to ensure uniform dose delivery.
- System dose mapping (dose uniformity, process interruptions)
- Comprehensive measurement of dose distribution within the irradiation volume.
- Evaluating dose uniformity and the impact of potential process interruptions.
- Procedures for maintenance, calibration, and requalification
- Establishing documented procedures for routine system maintenance.
- Setting calibration schedules for critical instruments.
- Defining requalification requirements after maintenance or significant changes.
- Software Validation
- Validation of any software used to control, monitor, or record data from the irradiation system.
- Ensuring software functions as intended and data integrity is maintained.
System Testing and Validation
- ISO 13485 / ASTM / ISO 11137 Compliant E-beam and X-Ray system IQ and OQ testing
- Installation Qualification (IQ): Verification that the system is installed according to specifications.
- Operational Qualification (OQ): Verification that the system operates within specified limits under anticipated operating ranges.
- Site acceptance testing and irradiator characterization
- Testing conducted at the client's site to ensure the system meets agreed-upon specifications.
- Characterizing the irradiator's performance parameters (energy, beam current, scan width).
- Critical parameter testing (scan width, beam energy, beam current)
- Detailed testing of key system parameters that influence dose delivery and uniformity.
- Ensuring these parameters are consistent and within validated ranges.
- Conveyance system testing (conveyor speed and tracking)
- Testing of the system that moves products through the irradiation field.
- Verifying consistent speed and accurate tracking to ensure uniform dose delivery.
- System dose mapping (dose uniformity, process interruptions)
- Comprehensive measurement of dose distribution within the irradiation volume.
- Evaluating dose uniformity and the impact of potential process interruptions.
- Procedures for maintenance, calibration, and requalification
- Establishing documented procedures for routine system maintenance.
- Setting calibration schedules for critical instruments.
- Defining requalification requirements after maintenance or significant changes.
- Software Validation
- Validation of any software used to control, monitor, or record data from the irradiation system.
- Ensuring software functions as intended and data integrity is maintained.
Installation Qualification (IQ)
- Physical Installation Verification:
Checking that equipment is installed per the manufacturer's specifications, including power connections, cooling systems, and safety interlocks.
- Software Installation Validation:
Ensuring software is installed correctly and configurations match the required setup.
- Documentation Verification: Confirming all necessary manuals, drawings, and calibration certificates are available.
Operational Qualification (OQ)
- Irradiator Performance Parameters:
Characterizing and verifying the irradiator's performance parameters (energy, beam current, scan width) within specified operational ranges. This includes confirming that the system can consistently achieve and maintain these parameters. - Dose Uniformity:
Testing dose uniformity within the irradiation volume under various operating conditions. This involves demonstrating that the system can deliver a consistent dose within defined limits. - Process Interruption Impact:
Evaluating the impact of potential process interruptions on dose delivery and uniformity. This may involve simulating interruptions and assessing the system's response.
- Control System Validation: Verifying the functionality of the control system, including safety interlocks, monitoring systems, and reporting capabilities.
Performance Qualification (PQ)
- Product Dose Mapping:
Comprehensive measurement of dose distribution within actual product loads. This verifies that the product receives the required dose range throughout the entire volume.
- Process Capability Assessment:
Establishing the E-beam process's ability to consistently meet product specifications over time. This involves running production batches and collecting dose data to demonstrate process stability and reliability.
- Dosimetry System Performance: Validating the performance of the dosimetry system in the actual production environment, including accuracy and repeatability of dose measurements.
Installation Qualification (IQ)
- Physical Installation Verification:
Checking that equipment is installed per the manufacturer's specifications, including power connections, cooling systems, and safety interlocks.
- Software Installation Validation:
Ensuring software is installed correctly and configurations match the required setup.
- Documentation Verification: Confirming all necessary manuals, drawings, and calibration certificates are available.
Operational Qualification (OQ)
- Irradiator Performance Parameters:
Characterizing and verifying the irradiator's performance parameters (energy, beam current, scan width) within specified operational ranges. This includes confirming that the system can consistently achieve and maintain these parameters. - Dose Uniformity:
Testing dose uniformity within the irradiation volume under various operating conditions. This involves demonstrating that the system can deliver a consistent dose within defined limits. - Process Interruption Impact:
Evaluating the impact of potential process interruptions on dose delivery and uniformity. This may involve simulating interruptions and assessing the system's response.
- Control System Validation: Verifying the functionality of the control system, including safety interlocks, monitoring systems, and reporting capabilities.
Performance Qualification (PQ)
- Product Dose Mapping:
Comprehensive measurement of dose distribution within actual product loads. This verifies that the product receives the required dose range throughout the entire volume.
- Process Capability Assessment:
Establishing the E-beam process's ability to consistently meet product specifications over time. This involves running production batches and collecting dose data to demonstrate process stability and reliability.
- Dosimetry System Performance: Validating the performance of the dosimetry system in the actual production environment, including accuracy and repeatability of dose measurements.
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