Time schedule
COURSE: Validation and Process Control for Electron Beam Sterilization
Risø HDRL |
Validation and Process Control for Electron Beam Sterilization - 2025 |
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| Monday | Tuesday | Wednesday | Thursday | Friday | |
| 09:00 | 0 Introduction | Summary of Monday activities | Summary of Tuesday activities | Summary of Wednesday activities | Summary of Thursday activities |
| 1 Irradiation facilities | 6 Measurement traceability | 10 International standards - ISO 11137 and ASTM | 11 Biocompatibility |
16 Dose measurement verification - comparisons |
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| 10:00 | 7 Measurement uncertainty | ||||
| 2 Dosimetry systems | Recap IQ - OQ | 12 Microbiology Introduction Methods 1 |
17 Process control | ||
| 3 Calibration | 8 Influence of environment on dosimeter response | OQ - Operational qualification | |||
| 11:00 | Prepare calib dosimeters for irradiation | Measure dosimeters | 18 Radiation effects on polymers | ||
| 4 Validation - IQ-OQ | 9 RisøScan | Analysis of data | 13 Microbiology Inactivation Methods 2 |
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| Required measurements | 19 Establish maximum acceptable dose | ||||
| 12:00 | LUNCH | ||||
| 13:00 | Prepare OQ dosimeters for irradiation | Recap Calibration | Recap PQ | 13 Microbiology (cont) | 20 Audit of device manufacturer and contract irradiator |
| Exercices | |||||
| 14:00 | 5 PQ | Measure dosimeters | Performance qualification | 14 Microbiology Establish sterilization dose |
Wrapping up |
| Dose mapping | Measure dosimeters | ||||
| 15:00 | Prepare products for irradiation | Establish calibration functions | Analysis of data | Close: approx. 15:00 | |
| 16:00 | for GEX DoseStix | Exercices | |||
| Driving to Sterigenics | for B3/RisøScan | Establish process specification for sterilization | 15. Maintaining process effectiveness | ||
| 17:00 | |||||
| Evening: | Evening Dinner | ||||
| Irradiation at Sterigenics 10 MeV electron accelerator facility | |||||