Time schedule
COURSE: Validation and process control for electron beam sterilization
Validation and process control for electron beam sterilization, 2027 |
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Day 1 |
Day 2 |
Day 3 |
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09:00 |
Introduction |
Measurement traceability |
PQ - Dose mapping |
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Electron accelerator facilities |
Measurement uncertainty |
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Standards -- Principles of IQ-OQ-PQ |
Establish uncertainty budget |
Prepare products for irradiation |
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Guide on the use of low energy e-beam for decontamination |
Influence of environment parameters |
Measure dosimeters |
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10:30 |
Dosimeter systems |
IQ-OQ |
Analysis of data |
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Alanine films |
Dose as function of current, speed, beam width |
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Risø B3, GEX, FWT |
Beam Penetration (Energy) |
Process control |
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RisøScan |
Reference product dose map |
Use of uncertainty data |
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Dµ - principles and method |
Process interruption |
Setting of irradiation parameters |
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LUNCH |
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13:00 |
Calibration |
Prepare dosimeters for irradiation |
Establish maximum acceptable dose |
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Prepare dosimeter for irradiation |
Irradiation of samples and dosimeters |
Effect of radiation on polymers |
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Irradiation of dosimeters |
Measure dosimeters |
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Analysis of data |
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15:00 |
Measure dosimeters |
Selecting the required dose for effective process |
Evaluation |
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RisøScan |
Microbiological aspects |
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Spectrophotometer |
ISO 11137 – methods |
Close approx. 15:00 |
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Establish calibration functions |
Low energy issues |
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Close 16:30 |
Verification of calibration |
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