Reliable dose verification and residual gas analysis for your ebeam system
Service area
Biodecontamination & process validation
Lifecycle
Design & QualificationModernization
Dosimetry at a glance
Validated process for your ebeam
Validated decontamination process
Ensuring ≥ 25 kGy on all external surfaces
Comprehensive dose mapping
Targeted testing under insert liners
Integrated residual gas analysis
Detection of critical by-products to ensure product safety and material compatibility
Customized test strategies
Adaptation to specific systems, container geometries, and requirements
Proven methods
Standardized procedures for material exposure and ozone quantification
Traceable calibration
Calibration via accredited reference laboratories with traceability to national standards
Audit-ready documentation
Proof of compliance with Annex 1, EN/ISO 11137, USP , and Ph. Eur. 5.1.2
Complete documentation package
Provision of all master documents, forms, image logs, and reports
Application
Validated process development for your ebeam
System qualification
When installing or retrofitting an ebeam system, dosimetry is essential. It enables the determination of optimum process parameters and ensures that the required minimum dose of 25 kGy is achieved on all external RTU container surfaces.
Product modifications
Introducing new container types or switching to a new routine dosimeter batch requires renewed dose verification.
Process
From planning to the final report
1
Requirement definition
Precise assessment of your specifications for dose targets, container geometry, and requested residual gas analyses.
2
Documentation preparation
Preparation of a complete test documentation package for pre-approval and release.
3
Calibration (reference lab)
In-situ calibration of the ebeam system using an accredited reference lab (e.g. Risø High Dose Reference Laboratory) to ensure traceability.
4
On-site testing
Execution of several consecutive dose and, if required, residual gas tests directly on your system.
5
Dose analysis
Measurement of the dose using B3 film dosimeters on all external surfaces and under insert liners.
6
Residual gas analysis
Quantification of the concentrations of possible by-products such as ozone (O₃), nitrogen oxides (NOₓ, NO₂), and nitric acid (HNO₃) in the exhaust gas or containers.
7
Reporting
Provision of full documentation including master documents, forms, image records, and a conclusive final report.
Service highlights
Optimally tailored to your ebeam system
Reliable dose distribution
Dosimetry ensures that the required minimum dose is achieved on all relevant surfaces. This demonstrates reproducible decontamination performance under real process conditions.
Safe assessment of by-products
In addition to dose verification, potentially generated gaseous by-products are analyzed. This provides transparency regarding possible impacts on product quality and material compatibility.
Solid basis for validation
The dosimetry results provide a robust foundation for qualification and routine operation. They support traceable documentation and facilitate compliance with regulatory requirements.
For new filling lines or retrofitting of the ebeam system
Dose verification renewal
After changes in container configurations and routine dosimeter charge
Study
Detailed dosimetry and residual gas study tailored to your system
Documentation
Complete documentation package including master documents, forms, image logs, and final report
Dosimeters used
Radiochromic B3 film dosimeters (B3 DoseStix)
Dose measurement range
1–160 kGy (calibration range approx. 5–100 kGy)
Ozone measurement range
1.5–800 ppb
FAQs
It confirms that the required dose (e.g. ≥ 25 kGy on all external surfaces) is achieved for effective decontamination, while also monitoring potential by-products.
B3 DoseStix are used and analyzed via spectrophotometry at 552 nm.
After requirements are defined and documentation is prepared, calibration is performed on-site (incl. approx. 2 weeks waiting time), followed by on-site tests and final reporting.
Possible gases include ozone (O₃), nitrogen oxides (NOₓ, NO₂), and nitric acid (HNO₃); they are quantified in exhaust gas and, if required, in the containers.
Standardized active ozone challenge tests can be performed to assess material compatibility.
