GEX Document Library

NVLAP Accreditation Certification to ISO/IEC 17025:2017 – Calibration Laboratories

Product information for all products manufactured with B3 Film, including GEX B3 dosimeter, B3 WINdose dosimeter, and B3 DoseStix dosimeter radiochromic film products – GEX Product No. B350x, B300x, B300xDS.

Energy Wedge Array Card (B3WINdose Radiochromic Film Dosimeter Array for Risø Wedge), used for e-beam energy testing. GEX Product No. B3110 / B3112

Product information for the 10 inch Uniformity Measurement Strip ( B3 WINdose Radiochromic Film Dosimeters Array), GEX Product No. B3106.

Gamma calibration phantoms are used for performing in-situ batch calibration of dosimeters in gamma irradiation facilities. GEX Product No. P1010 (standard size phantom) and P1011 (small size phantom).

Electron beam calibration phantoms are used for performing in-plant batch calibration of dosimeters in electron beam irradiation facilities. GEX Product No. P1020 (for 10 MeV) and P1030 (for 5 MeV).

The GEX P8003 Irreversible Temperature Indicators are a self-adhering, self-activating, monitoring tool that provides
a visual and irreversible record of the maximum temperature exposure.

The Spectronic Standards Set 2 is a certified, NIST traceable standards set used for performance verification of certain
UV-Visible spectrophotometers. Manufactured by Thermo Fisher Scientific. GEX Product No. P4220.

Film Dosimeter Hinged Holder for WINdose-Gen30 System. GEX Product No. P4502.

PENvac Dosimeter Handling Tool uses suction that will allow a user to pick-up the individual dosimeter and maintain control while moving the dosimeter from package to holder with minimal impact to the delicate dosimeter film. GEX Product No. P8005.

Wedge manufactured to specifications of the High Dose Reference Laboratory at Denmark’s Risø National Laboratory. Used to measure energies between approximately 2 MeV and 20 MeV. Each wedge is tested and certified by Risø in a 10 MeV electron accelerator. GEX Product No. P4701.

Risø Calorimeters: B6001 5 MeV Polystyrene Calorimeter; B6002 6-10 MeV Polystyrene Calorimeter; B6004 6-10 MeV Graphite Calorimeter. Used for measurement of dose by irradiation in electron accelerators. GEX Product No’s: B6001/6002/6004.

B3 film – sheets and strips. GEX Product No.’s B3100/3102/3103.

Micro-Incubator Heat Treatment System with Timer. GEX Product No. P4900.

Radiation Indicators are Type 1 process chemical indicators. Show yellow to purple color change, reaction begins at 3 kGy. GEX Product No. P8100.

Digital Thermometer is used to validate the temperature displayed by the temperature controller of the P4900 Micro-Incubator. GEX Product No. P4901.

T-Type Thermocouple B3 Probe (for use with P4900 and P4901), used to validate temperature of the P4900 MicroIncubator. GEX Product No. P4902.

GEX provides complete and formalized dosimeter batch calibration services for a wide range of applications. Conforms to current recommended methods published
in ISO/ASTM 51261. GEX Product No’s: S1101/1102.

Heat Treatment Incubator is a dosimeter heat treatment system comprised of a forced air incubator, a timer and a thermometer. Manufactured by Memmert. GEX Product No. P4850 / P4855.

Thermo Scientific Evolution (Evo) Spectrophotometer, for use with DoseControl-Evo Dosimetry System. GEX Product No. P4300.

The Mercury Lamp Accessory for the Thermo Scientific Evolution Spectrophotometer is a physical standard that never requires calibration, and can be used to calibrate or verify the performance of the instrument’s wavelength accuracy. GEX Product No. P4310.

Part of the Evo Dosimeter Holder System, the P4330 is a baseplate that integrates into the sample compartment of the Evolution (Evo) Spectrophotometer. GEX Product No. P4330.

B3 DoseStix dosimeter holder for DoseControl-Evo System. GEX Product No. P4332.

B3 WINdose/FWT dosimeter holder for DoseControl-Evo System. GEX Product No. 4334.

PMMA dosimeter holder – Red/Amber Perspex for DoseControl-Evo System. GEX Product No. P4336.

Metralight MX-2 Laser micrometer is a component of the DoseControl-Evo Dosimetry System used to measure the thickness of Harwell PMMA (Perspex) Dosimeters. GEX Product No. P4350

MS-2 Barcode Scanner for DoseControl-Evo System, integrated into the Thermo Evolution Spectrophotometer. GEX Product No. P4360.

Genesys 30 Spectrophotometer; integrates with DoseControl-GEN30 Dosimetry System. GEX Product No. P4400.

Genesys 30 Dosimeter Holder System is designed for easy installation inside of the Thermo Scientific GENESYS 30 Spectrophotometer, allowing users to measure GEX DoseStix and WINdose style dosimeters. GEX Product No.’s P4405/P4410/P4420/P4430.

A pre-aligned tungsten-halogen lamp exclusively for user replacement of the lamp in the Thermo GENESYS 30
Spectrophotometer. GEX Product No. P4401.

A fixture which is used for the arrangement of discs containing alanine transfer dosimeters and pouches of B3 film dosimeters, in proper geometry, to ensure that the dosimeters receive the same absorbed dose from nominal 5 MeV electron beam irradiation.GEX Product No. P1050.

A fixture which is used for the arrangement of discs containing alanine transfer dosimeters, and pouches of B3 film dosimeters, in proper geometry, to ensure that the dosimeters receive the same absorbed dose from nominal 10 MeV electron beam irradiation. GEX Product No. P1060.

The use of post-irradiation heat treatment (annealing) of B3 film dosimeters, and the process verification and validation testing of the heat treatment methodology.

Technical information about dosimetry system calibration including requirements, planning, selection, methods, maintenance, and calibration uncertainty.

High energy Ebeam energy calculation using GEX Wedge Array Cards in Riso Aluminum Wedge (4.5 to 12 MeV).

Technical information about low energy electron beam dosimetry for industrial radiation process applications, including calibration methods and factors impacting dosimetry.

Determining the integrity of measurement data when calibrating dosimeters.

Technical information about dose measurement uncertainty calculations within a dosimeter batch calibration.

Provides updated information about the Dµ method of calibration introduced in November 2007 by GEX and Risø High Dose Reference Laboratory that utilizes reference transfer standard alanine film dosimeters to provide doses traceable to a national standard.

Provides justification for use of the 525 nm wavelength filter supplied with the Thermo Spectronic Calibration Standards Set (GEX Part# P4220) that is used for calibration of the GENESYS 20 spectrophotometer.

Low Energy Electron Beam (80-300 keV) – Options for Traceable Dosimetry System Calibration.

The process for customer calibration data analysis and statistical tests that are performed on the curve fitting data. The document serves as a reference tool for customers to develop acceptance criteria for their internal procedures.

Technical report discussing a transfer standard alanine study.

Discusses a study conducted under in-situ conditions similar to typical applications of usage for the P8003 product, and analyzes the accuracy of the chemistry and color development activation.

Many options are available for Performance Verification (P.V.) testing of the Evolution Spectrophotometer. Users may find it difficult to determine what P.V. method to use, which are ‘required’, which are ‘recommended’ by GEX or Thermo Fisher Scientific, and most importantly what is best for the user’s application. This document discusses the available options, and provides a method to assist users in making a decision to fit their needs.

This procedure describes how to implement protective measures and test methods to mitigate and protect B3 film dosimeters from potential exposure to daylight and UV light sources.

This procedure describes the methods of evaluating the uncertainty of instrumentation and personnel during dosimeter calibration and routine use.

Provides general information and requirements for a suitable dosimetry lab area.

This procedure describes GEX recommended practices for the receipt and inspection of GEX B3 Dosimeter shipments.

Dosimeter Stock Receiving Inspection Form (MS Excel), for use with GEX Doc Procedure #100-256.

Describes the process for post-irradiation handling and measurement for GEX B3 dosimeters.

To describe the method for investigating and evaluating suspected outlier measurements or measurements that differ from the expected dose.

To describe the method of dose uniformity measurement using the B3 WINdose B3106 Uniformity Measurement dosimeter strips with the WINdose for Excel Dosimetry Program. This procedure is relevant to scan width/length dose uniformity measurement and can be used for conveyor travel dose uniformity measurement.

To establish a mathematical function that relates the change in dosimeter response to dose (Gy or kGy) traceable to a national standard with an associated level of uncertainty using irradiations performed in-plant with transfer-standard dosimeters from an accredited laboratory.

User guide for DoseControl dosimetry software used with the Evolution-DoseControl and GENESYS30-DoseControl Dosimetry Systems. Software versions 1.5.2020.11.17000 and 1.5.2023.2.17000. View document in knowledge-base: KB-100-266 DoseControl User Guide_RevL

The DoseControl® System is a single dosimetry system solution, specifically developed to satisfy dosimetry needs of radiation sterilization application.

MS Excel form, used for performance verification of the Evolution spectrophotometer in accordance with GEX Doc. Procedure# 100-271, and the GENESYS 30 spectrophotometer in accordance with GEX Doc Procedure #100-270.

GENESYS 30 Performance Verification Procedure, for use with Doc #100-269 Form.

Evolution Spectrophotometer Performance Verification Procedure, for use with Doc #100-269 Form.

Spectrophotometer Measurement Repeatability Form (MS Excel), for use with GEX Procedure Doc. #100-273.

Provides explicit instructions for testing measurement repeatability using a spectrophotometer and dosimeter holder
system at 3 (three) doses over the range of use.

Integrated Barcode Scanner IQOQ Test Form, for use with GEX Procedure Doc. #100-275.

Integrated Barcode Scanner IQOQ Test Procedure, for use with Form Doc. #100-274.

Heat Treatment Incubator IQOQ Test Procedure, for use with Form Doc. #100-277.

Provides detailed descriptions of the functional specifications for the GEX DoseControl Dosimetry System,
related to data integrity and electronic records compliance.

Incubator IQOQ Test Form, for use with GEX Procedure Doc#100-276.

Current ISO 9001:2015 Scope: Design, Provision, Installation, and Qualification of Dosimetry Systems and Accessories (includes Hardware and Software) for Radiation Processing, and Dosimetry System Calibration Services.

Quality Manual. Updated 08-March-2024, version S.

Scope of Accreditation (PDF file). GEX is an international standards laboratory accredited by NVLAP to ISO/IEC 17025:2017 for calibrations and dose measurements for ionizing radiation for high-dose dosimetry in the range 0.25 kGy to 100 kGy. NVLAP Lab Code: 600080-0. Effective dates 01 April 2024 through 31 Mar 2025.

Purpose: The DoseControl Software Configuration Plan is used to compile configuration information prior to software installation. In addition, this Plan document is a requirement for execution of the IQ/OQ Protocol for DoseControl Dosimetry System, GEX Doc# 100-280.

Complete planning and implementation documentation for the DoseControl Dosimetry System (MS Word). Includes planning checklists, Test Cases, and summary for software and hardware IQ/OQ.

Aluminum wedge designed to utilize the Part# B3150, GEX Wedge Array Card for the measurement of electron beam depth-dose profile and energy estimation for surface energies ranging from appx. 1.70 to 4.10 MeV.

The B3150 Energy Wedge Array Card is placed in the GEX Part# P4701 Risø Aluminum Energy Wedge (4.5 – 10 MeV) or the GEX Part# P4705, GEX Aluminum Energy Wedge (2 – 4 MeV) and used for electron beam energy estimation.

Complete planning and implementation documentation for the RisøScan Dosimetry System. Includes planning checklists and Test Cases for software and hardware IQ/OQ.

Instruction on replacing the core assembly piece of the aluminum heat block used with the P4900 Microincubator.

Matrix120 Barcode Scanner for DoseControl Dosimetry System. Designed to be mounted, connected, and used with both the Thermo Evolution Spectrophotometer and Genesys 30 Spectrophotometer, and utilized by the DoseControl software. GEX Product No. P4390 and P4450.

Datalogic Heron 2D Barcode Scanner for GEX B3 products. Dual barcode reading capability allows it to read WINdose and DoseStix dosimeters, both 1D and 2D barcodes. Requires no special software. GEX Product No. P4205.

Integrated Barcode Scanner IQOQ Test Procedure, for use with Form Doc. #100-279.

Integrated Barcode Scanner IQOQ Test Form, for use with GEX Procedure Doc. #100-278.

The Custom Gage Blocks (GEX P/N: P4355) are a set of custom fabricated Grade 00 gage blocks designed to fit specifically into the P4336 PMMA Dosimeter Holder and used for performance verification of the P4350 MX2 Laser Micrometer. Each set consists of three individual gage blocks with nominal thicknesses of 2.0, 3.0 and 4.0mm (±0.1mm). Calibration certificate provided.

Describes the systems and related set of controls that comprise the Dosimetry Laboratory Operations which supports the overall operations for the irradiation process.

This manual provides instructions in using the standardized features of DoseControl® to integrate with imported and exported data.

This statement provides the compliance status for GEX Corporation products with the following directives or regulations: REACH (EC 1907/2006), Candidate list of 223 Substances of Very High Concern (SVHC).

User guide for DoseControl dosimetry software used with the Evolution-DoseControl and GENESYS30-DoseControl Dosimetry Systems. Software version 2.0.0. This document is also available as a knowledge-base: KB-100-266 DoseControl User Guide