ASTM E2303-03

Standard Guide for Absorbed-Dose Mapping in Radiation Processing Facilities

SIGNIFICANCE AND USE
Radiation processing is carried out under fixed path conditions where (a) a process load is automatically moved through the radiation field by mechanical means or (b) a process load is irradiated statically by manually placing product at predetermined positions before the process is started. In both cases the process is controlled in such a manner that the process load position(s) and orientation(s) are reproducible within specified limits.
Some radiation processing facilities that utilize a fixed conveyor path for routine processing may also characterize a region within the radiation field for static radiation processing, sometimes referred to as “Off Carrier” processing.
Radiation processing may require a minimum absorbed dose (to achieve a desired effect or to fulfill a legal requirement), and a maximum dose that can be tolerated (while the product, material or substance still meets functional specifications or to fulfill a legal requirement).
Dose mapping is used to characterize the radiation process and assess the reproducibility of absorbed-dose results, which may be used as part of operational qualification and performance qualification.
Dose mapping is used to determine the spatial distribution of absorbed doses and the zone(s) of maximum and minimum absorbed doses throughout a process load, which may consist of an actual or simulated product.
Dose mapping is used to establish the relationship between the dose at a reference position and the dose within the minimum and maximum dose zones established for a process load.
Dose mapping is used to verify mathematical dose calculation methods. See Guide E 2232.
Dose mapping is used to determine the process shutdown and startup transit dose effect on the distribution of absorbed dose and the magnitude of the minimum and maximum doses.
Dose mapping is used to assess the impact on the distribution of absorbed dose and the magnitude of the minimum and maximum doses resulting from the transition from on...
SCOPE
1.1 This document provides guidance in determining absorbed-dose distributions in products, materials or substances irradiated in gamma, X-ray (bremsstrahlung) and electron beam facilities.
Note 1—For irradiation of food and the radiation sterilization of health care products, other specific ISO and ISO/ASTM standards containing dose mapping requirements exist. For food irradiation, see ISO/ASTM 51204, Practice for Dosimetry in Gamma Irradiation Facilities for Food Processing and ISO/ASTM 51431, Practice for Dosimetry in Electron and Bremsstrahlung Irradiation Facilities for Food Processing. For the radiation sterilization of health care products, see ISO 11137: 1995, Sterilization of Health Care Products Requirements for Validation and Routine Control Radiation Sterilization. In those areas covered by ISO 11137, that standard takes precedence. ISO/ASTM Practice 51608, ISO/ASTM Practice 51649, and ISO/ASTM Practice 51702 also contain dose mapping requirements.
1.2 Methods of analyzing the dose map data are described. Examples are provided of statistical methods that may be used to analyze dose map data.
1.3 Dose mapping for bulk flow processing and fluid streams is not discussed.
1.4 Dosimetry is only one component of a total quality program for an irradiation facility. Other controls besides dosimetry may be required for specific applications such as medical device sterilization and food preservation.
1.5 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory requirements prior to use.

General Information

• Status: Historical
• Publication Date: 09-Jul-2003
• ICS: 13.280 - Radiation protection
• Technical Committee: E61 - Radiation Processing
• Drafting Committee: E61.03 - Dosimetry Application

Relations

• Replaced By: ASTM E2303-11 - Standard Guide for Absorbed-Dose Mapping in Radiation Processing Facilities
• Effective Date: 01-Jul-2011
• Referred By: ASTM ISO/ASTM51702-13(2021) - Standard Practice for Dosimetry in a Gamma Facility for Radiation Processing
• Effective Date: 10-Jul-2003
• Referred By: ASTM ISO/ASTM51608-15(2022) - Standard Practice for Dosimetry in an X-Ray (Bremsstrahlung) Facility for Radiation Processing at Energies between 50 keV and 7.5 MeV
• Effective Date: 10-Jul-2003
• Referred By: ASTM ISO/ASTM51649-15 - Standard Practice for Dosimetry in an Electron Beam Facility for Radiation Processing at Energies Between 300 keV and 25 MeV
• Effective Date: 10-Jul-2003

Standards Content (Sample)

NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
Contact ASTM International (www.astm.org) for the latest information
An American National Standard
Designation:E2303–03
Standard Guide for
Absorbed-Dose Mapping in Radiation Processing Facilities
This standard is issued under the fixed designation E2303; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision.Anumber in parentheses indicates the year of last reapproval.A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope E177 Practice for Use of the Terms Precision and Bias in
ASTM Test Methods
1.1 This document provides guidance in determining
E178 Practice for Dealing With Outlying Observations
absorbed-dose distributions in products, materials or sub-
E666 PracticeforCalculatingAbsorbedDoseFromGamma
stances irradiated in gamma, X-ray (bremsstrahlung) and
or X Radiation
electron beam facilities.
E668 Practice for Application of Thermoluminescence-
NOTE 1—Forirradiationoffoodandtheradiationsterilizationofhealth
Dosimetry(TLD)SystemsforDeterminingAbsorbedDose
care products, other specific ISO and ISO/ASTM standards containing
in Radiation-Hardness Testing of Electronic Devices
dose mapping requirements exist. For food irradiation, see ISO/ASTM
E1026 Practice for Using the Fricke Reference-Standard
51204, Practice for Dosimetry in Gamma Irradiation Facilities for Food
Dosimetry System
ProcessingandISO/ASTM51431,PracticeforDosimetryinElectronand
Bremsstrahlung Irradiation Facilities for Food Processing. For the radia- E2232 Guide for Selection and Use of Mathematical Meth-
tion sterilization of health care products, see ISO11137: 1995, Steriliza-
odsforCalculatingAbsorbedDoseinRadiationProcessing
tion of Health Care Products Requirements for Validation and Routine
Applications
Control Radiation Sterilization. In those areas covered by ISO11137, that
2.2 ISO/ASTM Standards:
standard takes precedence. ISO/ASTM Practice 51608, ISO/ASTM Prac-
ISO/ASTM 51204 Practice for Dosimetry in Gamma Irra-
tice 51649, and ISO/ASTM Practice 51702 also contain dose mapping
diation Facilities for Food Processing
requirements.
ISO/ASTM 51205 Practice for Use of a Ceric-Cerous Sul-
1.2 Methods of analyzing the dose map data are described.
fate Dosimetry System
Examples are provided of statistical methods that may be used
ISO/ASTM 51261 Guide for Selection and Calibration of
to analyze dose map data.
Dosimetry Systems for Radiation Processing
1.3 Dose mapping for bulk flow processing and fluid
ISO/ASTM51275 PracticeforUseofaRadiochromicFilm
streams is not discussed.
Dosimetry System
1.4 Dosimetry is only one component of a total quality
ISO/ASTM 51276 Practice for Use of a Polymethylmeth-
program for an irradiation facility. Other controls besides
acrylate Dosimetry System
dosimetry may be required for specific applications such as
ISO/ASTM 51310 Practice for Use of a Radiochromic
medical device sterilization and food preservation.
Optical Waveguide Dosimetry System
1.5 This standard does not purport to address all of the
ISO/ASTM 51400 Practice for Characterization and Perfor-
safety concerns, if any, associated with its use. It is the
mance of a High-Dose Radiation Dosimetry Calibration
responsibility of the user of this standard to establish appro-
Laboratory
priate safety and health practices and determine the applica-
ISO/ASTM51401 PracticeforUseofaDichromateDosim-
bility of regulatory requirements prior to use.
etry System
ISO/ASTM 51431 Practice for Dosimetry in Electron and
2. Referenced Documents
Bremsstrahlung Irradiation Facilities for Food Processing
2.1 ASTM Standards:
ISO/ASTM 51538 Practice for Use of the Ethanol-
E170 TerminologyRelatingtoRadiationMeasurementsand
Chlorobenzene Dosimetry System
Dosimetry
ISO/ASTM 51540 Practice for Use of a Radiochromic
Liquid Dosimetry System
ISO/ASTM 51607 Practice for Use of the Alanine-EPR
This guide is under the jurisdiction of ASTM Committee E10 on Nuclear
Dosimetry System
TechnologyandApplicationandisthedirectresponsibilityofSubcommitteeE10.01
on Dosimetry for Radiation Processing.
Current edition approved July 10, 2003. Published August 2003 DOI: 10.1520/
E2303-03. Standards on Dosimetry for Radiation Processing. ASTM International 2002.
For referenced ASTM standards, visit the ASTM website, www.astm.org, or ForreferencedASTMstandards,visittheASTMwebsite,www.astm.org,orcontact
contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM ASTM Customer Service at [e-mail]. For Annual Book of ASTM Stan-
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the ASTM website. ASTM website.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
E2303–03
ISO/ASTM 51608 Practice for Dosimetry in an X-ray 3.1.6 dose zone—a volume or discrete point(s) within a
(Bremsstrahlung) Facility for Radiation Processing process load that receives the same absorbed dose within the
ISO/ASTM 51631 Practice for Use of Calorimetric Dosim- statistical uncertainty of the irradiation process and absorbed
etry Systems for Electron Beam Dose Measurements and dose measurement(s).
Dosimeter Calibrations
3.1.7 installation qualification (IQ)—obtaining and docu-
ISO/ASTM 51649 Practice for Dosimetry in an Electron menting evidence that equipment has been provided and
beam Facility for Radiation Processing at Energies be-
installed in accordance with its specification.
tween 300 keV and 25 MeV
3.1.8 operational qualification (OQ)—obtaining and docu-
ISO/ASTM 51650 Practice for Use of Cellulose Acetate
menting evidence that installed equipment operates within
Dosimetry Systems
predetermined limits when used in accordance with its opera-
ISO/ASTM 51702 Practice for Dosimetry in a Gamma
tional procedures.
Irradiation Facility for Radiation Processing
3.1.9 performance qualification (PQ)—obtaining and docu-
ISO/ASTM 51707 Guide for Estimating Uncertainties in
mentingevidencethattheequipment,asinstalledandoperated
Dosimetry for Radiation Processing
in accordance with operational procedures, consistently per-
ISO/ASTM 51818 Practice for Dosimetry in an Electron
forms in accordance with predetermined criteria and thereby
Beam Facility for Radiation Processing at Energies be-
yields product meeting its specification.
tween 80 and 300 keV
3.1.10 process load—a volume of material with a specified
2.3 International Commission on Radiation Units and
loading configuration irradiated as a single entity.
Measurements Reports:
3.1.11 reference position—dose measurement position with
ICRU Report 14 Radiation Dosimetry: X-Rays and Gamma
an established relationship to the minimum and/or maximum
RayswithMaximumPhotonEnergiesBetween0.6and50
dose zones.
MeV
3.1.12 simulated product—material with attenuation and
ICRUReport17 RadiationDosimetry:X-RaysGeneratedat
scatteringpropertiessimilartothoseoftheproduct,materialor
Potentials of 5 to 150 kV
substance to be irradiated.
ICRU Report 34 The Dosimetry of Pulsed Radiation
3.1.12.1 Discussion—Simulated product may be used dur-
ICRUReport35 RadiationDosimetry:ElectronBeamswith
ing operational qualification as a substitute for the actual
Energies Between 1 and 50 MeV
product, material or substance to be irradiated. When used in
ICRU Report 37 Stopping Powers for Electrons and
routineproductionruns,itissometimesreferredtoascompen-
Positrons
sating dummy. When used for absorbed-dose mapping, simu-
ICRU Report 60 Fundamental Quantities and Units for
lated product is sometimes referred to as phantom material.
Ionizing Radiation
3.2 Definitions of other terms used in this standard that
2.4 International Organization for Standardization:
pertain to radiation measurement and dosimetry may be found
ISO 11137 Sterilization of Health Care Products—
inTerminology E170. Definitions in E170 are compatible with
Requirements for Validation and Routine Control—
ICRU 60; that document, therefore, may be used as an
Radiation Sterilization
alternative reference.
3. Terminology
4. Significance and Use
3.1 Definitions:
4.1 Radiation processing is carried out under fixed path
3.1.1 absorbed-dose mapping —measurement of absorbed
conditions where (a) a process load is automatically moved
dosewithinaprocessloadusingdosimetersplacedatspecified
through the radiation field by mechanical means or (b)a
locations to produce a one, two or three-dimensional distribu-
process load is irradiated statically by manually placing prod-
tion of absorbed dose, thus rendering a map of absorbed-dose
uct at predetermined positions before the process is started. In
values.
both cases the process is controlled in such a manner that the
3.1.2 calibration curve—graphical representation of the
process load position(s) and orientation(s) are reproducible
dosimetry system’s response function.
within specified limits.
3.1.3 container—carrier,tote,cart,trayorothercontainerin
4.2 Some radiation processing facilities that utilize a fixed
which product is loaded to traverse the irradiation field. In
conveyor path for routine processing may also characterize a
some instances, this may be the actual product package.
region within the radiation field for static radiation processing,
3.1.4 dose map, dose mapping—See absorbed-dose map-
sometimes referred to as “Off Carrier” processing.
ping.
4.3 Radiation processing may require a minimum absorbed
3.1.5 dose uniformity ratio—ratio of the maximum to the
dose (to achieve a desired effect or to fulfill a legal require-
minimum absorbed dose within a process load. The concept is
ment), and a maximum dose that can be tolerated (while the
also referred to as the max/min dose ratio.
product, material or substance still meets functional specifica-
tions or to fulfill a legal requirement).
4.4 Dose mapping is used to characterize the radiation
Available from International Commission on Radiation Units and Measure-
processandassessthereproducibilityofabsorbed-doseresults,
ments, 7910 Woodmont Ave., Suite 800, Bethesda, MD 20814.
which may be used as part of operational qualification and
Available from International Organization for Standardization (ISO), 1 rue de
Varembé, Case postale 56, CH-1211, Geneva 20, Switzerland. performance qualification.
E2303–03
4.5 Dose mapping is used to determine the spatial distribu- 5.4 Measurement Instrument Calibration and Performance
tion of absorbed doses and the zone(s) of maximum and Verification—Forthecalibrationoftheinstruments,andforthe
minimum absorbed doses throughout a process load, which verification of instrument performance between calibrations,
may consist of an actual or simulated product. see ISO/ASTM Guide 51261 and/or instrument-specific oper-
4.6 Dose mapping is used to establish the relationship ating manuals.
betweenthedoseatareferencepositionandthedosewithinthe
minimum and maximum dose zones established for a process
6. Dose Mapping
load.
6.1 Dose Mapping for Operational Qualification of the
4.7 Dose mapping is used to verify mathematical dose
Irradiation Facility:
calculation methods. See Guide E2232.
6.1.1 As specified in Practices ISO/ASTM 51204, ISO/
4.8 Dose mapping is used to determine the process shut-
ASTM 51431, ISO/ASTM 51608, ISO/ASTM 51649, ISO/
down and startup transit dose effect on the distribution of
ASTM 51702 and ISO11137, perform irradiation facility dose
absorbed dose and the magnitude of the minimum and maxi-
mapping to characterize the irradiator with respect to the dose
mum doses.
distributionandreproducibilityofabsorbeddosedelivery.This
4.9 Dose mapping is used to assess the impact on the
should be performed in accordance with a formal validation
distribution of absorbed dose and the magnitude of the mini-
program over the operational range that will be used in the
mum and maximum doses resulting from the transition from
irradiation of products.
one process load to another where changes, for example, in
6.1.2 Perform irradiation facility dose mapping by placing
density or product loading pattern may occur.
dosimeters in a process load of homogeneous density material
that fills the container to its design volume limits. Material
5. Prerequisites
densities should be within the density range for which the
5.1 Installation Qualification, Dosimetry and Other Prereq-
irradiator is to be used. In electron beam facilities, a single
uisites to Dose Mapping:
material density may be used provided the maximum and
5.1.1 Prior to performing the irradiator operational qualifi-
minimum process settings that affect dose are demonstrated
cation(OQ)andperformancequalification(PQ)dosemapping,
(for example, conveyor speed, beam current, scan frequency
confirm that installation qualification (IQ) is complete.
and scan height or width). Determine absorbed dose distribu-
5.1.2 Selectanappropriatedosimetrysystem(s)forthedose
tion throughout the process load for each product path through
mapping experiments. See ISO/ASTM Guide 51261 for guid-
the irradiation field.
ance.
Discussion—Electron beam irradiation facilities may satisfy
the dose mapping requirements described in 6.1.2 using a two
NOTE 2—For requirements on the qualification of equipment and
control systems, refer to ISO/ASTM Standard Practices 51204, 51431, dimensional surface grid dose map with a separate penetration
51608, 51649, 51702, and ISO11137.
test performed in a homogenous density material.Appropriate
methods should be used (see ISO/ASTM Practice 51649) to
5.2 Calibration of the Dosimetry System:
determine the electron beam energy. For process load fringe or
5.2.1 Prior to use, the dosimetry system (consisting of a
edge effect studies in electron beam, several different densities
specific batch of dosimeters and specific measurement instru-
of homogeneous material should be used. The maximum
ments) shall be calibrated in accordance with the user’s
electron beam process area limits may be determined by
documented procedure that specifies details of the calibration
demonstrating the uniformity of absorbed dose in both the
process and quality assurance requirements. This calibration
direction of scan and direction of travel under the maximum
process shall be repeated at regular intervals to ensure that the
and minimum process settings that affect dose (for example,
accuracy of the absorbed-dose measurement is maintained
conveyor speed, beam current, scan frequency and scan height
within required limits. Calibration methods are described in
orwidth).Differentproductpathsthroughtheradiationprocess
ISO/ASTM Guide 51261.
field need not be a physical transport path but may be created
5.3 Calibration Irradiation of Dosimeters—Irradiation is a
by variation(s) made to irradiator process setting
...