Gamma Irradiation
Gamma Irradiation
Gamma Irradiation
Denise A. Cleghorn
Boston Scientific Corp.
Vice Chair, ASTM E61 – Radiation Processing: Dosimetry & Applications
Tuesday, October 23, 2012
1
Questions to Ask Yourself
1. What product am I irradiating?
2. What is the intended effect to be achieved?
2
What is the intended effect
to be achieved?
Phytosanitary Treatment of Produce
.
up to 1 kGy
3
What is the intended effect
to be achieved?
Elimination of Pathogens
3 – 30 kGy
4
What is the intended effect
to be achieved?
Sterilization of Healthcare Products / Medical Devices
25 kGy
5
What standards should I follow?
Industry Standard for Food:
6
What standards should I follow?
Industry Standard for Health Care Products:
ISO 11137-1:2006 “Sterilization of Healthcare Products – Radiation –
Part 1: Requirements for development, validation, and routine
control of a sterilization process for medical devices”
ISO 11137-2:2012 “Sterilization of Healthcare Products – Radiation –
Part 2: Establishing the sterilization dose”
ISO 11137-3:2006 “Sterilization of Healthcare Products – Radiation –
Part 3: Guidance on dosimetric aspects” 1
1 Fourteen ASTM E10.01/E61 standards are referenced in ISO 11137-3:2006
7
What am I required to do?
Define your sterilization equipment (ISO 11137-1 Section 6)
DOSIMETRY
9
Why Dosimetry
Dosimetry is used in:
Maximum Dose Establishment - At what dose does the product fail?
Sterilization Dose Establishment - At what dose is the product SAL achieved?
Equipment Installation Qualification - Is the equipment delivering the dose
required?
10
Dose Measurement
Measurement
Traceability
11
DOSIMETRY
Dosimetry Standards – Measurement
ASTM E2628 “Standard Practice for Dosimetry in Radiation Processing”
12
Unbroken Calibration Chain
13
Traceability and Uncertainty
14
Traceability Chain
Standards
• Calorimeters
Laboratory • Ionization Chambers
Dw Gy (+1%) Dw kGy (+2%)
15
Traceability is achieved by:
16
Traceability can be lost by:
Calibration based on measurements from a laboratory that
cannot demonstrate traceability.
19
What am I required to do?
Define your sterilization equipment
• Radiation source
• Irradiator and its characteristics
• Location of the Irradiator
• Process controls
• Product Pathway
21
What am I required to do?
Validate your process
Equipment Installation Qualification
• Gamma Irradiator (ISO/ASTM 51702)
• Electron Beam Irradiator (ISO/ASTM 51649)
Beam Energy
Scan Width / Uniformity
• X-ray Irradiator (ISO/ASTM 51608)
Beam Energy
Scan Width / Uniformity
22
What am I required to do?
Validate your process (cont.)
Equipment Operational Qualification
• Gamma Irradiator (ISO/ASTM 51702 )
Dose Mapping (ASTM E2303)
• Electron Beam Irradiator (ISO/ASTM 51649)
Dose Mapping (ASTM E2303)
• X-ray Irradiator (ISO/ASTM 51608)
Dose Mapping (ASTM E2303)
Replicate dose maps are performed for specific product and load
configurations.
Correlation of dose at reference monitoring position to product dose are
measured to document variability.
24
What am I required to do?
Monitoring & Control of your process
Gamma Irradiator (ISO/ASTM 51702 )
25
ASTM E61 Radiation Processing
51276 PMMA
NEW Process 51900 Agricultural F1356 Red Meat and
51310 Optical Waveguide Control Research Poultry
51401 Dichromate
E2701 Performance
Characterization 51702 Gamma 51939 Blood F1640 Food Irradiation
51538 Ethanol
Chlorobenzene Irradiators Irradiation Packaging
51607 Alanine 51608 X-ray E2116 Self Contained F1736 Finfish &
Irradiators Dry Storage Aquatic Invertebrates
51261 Calibration
51631 Calorimetry