Qualification & Performance Verification of Dosimetry System

The B3 dosimeter product should be tested against expected performance criteria as part of a dosimeter measurement system (dosimetry system).

Performance verification interval

Performance verification of the B3 dosimeter measurement system is completed during qualification, and at user-defined intervals based on risk assessment as part of routine use of the system.

Industry guidance

ASTM 52628, ASTM 51275, ASTM 52701

GEX recommendations

The user is responsible for defining and writing the protocols for qualification and Performance Verification activities.

GEX provides numerous Guidance documents related to the qualification and Performance Verification of B3 Dosimeter products and GEX DoseControl Dosimetry System.

Spectrophotometer Operational Qualification (OQ) and performance verification

The user is responsible for qualification of the dosimeter measurement equipment and determining a performance verification method, based on internal business requirements, the B3 radiochromic dosimetry application, and industry guidance and standards. Per ASTM 51275 and 52701, the user should include the following:

Spectrophotometer wavelength accuracy - Verify wavelength accuracy at or near the analysis wavelength using calibrated references
Spectrophotometer photometric accuracy - Verify the accuracy of the optical absorbance measurement at or near the analysis wavelength over the full range of the absorbance scale utilized for measurement of the dosimeter, for example through the use of certified optical absorption filters
Dosimeter thickness - Users do not need to measure individual B3 dosimeter thickness. Each batch of B3 dosimeters has a certified dosimeter thickness, provided by GEX.
Spectrophotometer performance ‘Daily check’ program - Implementation of a daily check program intended to verify instrument performance before and after measurement sessions is also recommended.
Dosimeter measurement repeatability - Verify the dosimeter absorbance measurement repeatability using a spectrophotometer and GEX dosimeter holder system.

GEX offers a spectrophotometer qualification procedures for devices sold by GEX, available for customers.

GEX DoseControl Dosimetry System	Click link to download
Thermo Evolution Spectrophotometer	Evolution Spectrophotometer Performance Verification Procedure – GEX Doc. No. 100-271. (For use with Evo Performance Verification Test Form Doc #100-269, tab b or c). This Procedures provide methods for verification that absorbance measurements at a single wavelength made using the Thermo Scientific Evolution Spectrophotometer are traceable to a national standard and that the instrument is performing within specified limits. Spectrophotometer Performance Verification Test Form (Excel), tab b and c – GEX Doc. No. 100-269. (For use with the Evolution performance verification Procedure# 100-271)
Thermo GENESYS 30 Spectrophotometer	GENESYS 30 Spectrophotometer Performance Verification Procedure – GEX Doc. No. 100-270. (For use with Spectrophotometer Performance Verification Test Form Doc #100-269, tab a). This Procedure provides a method for performance verification testing of the GENESYS 30 Spectrophotometer that is traceable to a national standard and that the instrument is performing within specified limits using the Thermo Spectronic Standards Set 2. Spectrophotometer Performance Verification Test Form (Excel), tab a – GEX Doc. No. 100-269. (For use with the GENESYS 30 performance verification Procedure #100-270)
Spectrophotometer measurement repeatability test for Thermo Evolution and GENESYS 30 spectrophotometers	Spectrophotometer Measurement Repeatability Test Procedure - GEX Doc. No 100-273. A Procedure for testing dosimeter measurement repeatability using a spectrophotometer and GEX dosimeter holder system. Spectrophotometer Measurement Repeatability Test Form (MS Excel) – GEX Doc. No. 100-272. (For use with Measurement Repeatability Procedure 100-273)

GEX DoseControl Dosimetry System

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Thermo Evolution Spectrophotometer

Evolution Spectrophotometer Performance Verification Procedure – GEX Doc. No. 100-271. (For use with Evo Performance Verification Test Form Doc #100-269, tab b or c). This Procedures provide methods for verification that absorbance measurements at a single wavelength made using the Thermo Scientific Evolution Spectrophotometer are traceable to a national standard and that the instrument is performing within specified
limits.

Spectrophotometer Performance Verification Test Form (Excel), tab b and c – GEX Doc. No. 100-269. (For use with the Evolution performance verification Procedure# 100-271)

Thermo GENESYS 30 Spectrophotometer

GENESYS 30 Spectrophotometer Performance Verification Procedure – GEX Doc. No. 100-270. (For use with Spectrophotometer Performance Verification Test Form Doc #100-269, tab a). This Procedure provides a method for performance verification testing of the GENESYS 30 Spectrophotometer that is traceable to a national standard and that the instrument is performing within specified limits using the Thermo Spectronic Standards Set 2.

Spectrophotometer Performance Verification Test Form (Excel), tab a – GEX Doc. No. 100-269. (For use with the GENESYS 30 performance verification Procedure #100-270)

Spectrophotometer measurement repeatability test for Thermo Evolution and GENESYS 30 spectrophotometers

Spectrophotometer Measurement Repeatability Test Procedure - GEX Doc. No 100-273. A Procedure for testing dosimeter measurement repeatability using a spectrophotometer and GEX dosimeter holder system.

Spectrophotometer Measurement Repeatability Test Form (MS Excel) – GEX Doc. No. 100-272. (For use with Measurement Repeatability Procedure 100-273)

Heat Treatment device (incubator) Operational Qualification (OQ) and performance verification

GEX recommends post-irradiation heat treatment of B3 dosimeters. The user is responsible for determining qualification of the heat treatment equipment and determining a performance verification method, based on internal business requirements, the B3 radiochromic dosimetry application, and industry guidance and standards.

GEX offers a heat treatment device qualification procedure, available for customers.

GEX Heat Treatment Systems	Click link to download
GEX heat treatment devices	Heat Treatment Incubator IQOQ Procedure – GEX Doc. No. 100-276. (For use with Incubator IQOQ Test Form Doc. #100-277 ) Incubator IQOQ Test Form (MS Excel) – GEX Doc. No. 100-277. (For use with Incubator IQOQ Procedure Doc#100-276)

GEX Heat Treatment Systems

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GEX heat treatment devices

Heat Treatment Incubator IQOQ Procedure – GEX Doc. No. 100-276. (For use with Incubator IQOQ Test Form Doc. #100-277 )

Incubator IQOQ Test Form (MS Excel) – GEX Doc. No. 100-277. (For use with Incubator IQOQ Procedure Doc#100-276)

Internal Barcode Scanner Operational Qualification (OQ) and performance verification - for the DoseControl dosimetry system integrated barcode scanner

The GEX DoseControl Dosimetry System offers an integrated barcode scanner device that automatically captures the dosimeter ID at the time of measurement. The user is responsible for determining qualification of the barcode scanner device, based on internal business requirements, the B3 radiochromic dosimetry application, and industry guidance and standards.

GEX offers a barcode scanner device qualification procedure for the Datalogic Matrix 120 barcode scanner installed in the DoseControl-Evolution Dosimetry System or the DoseControl-GENESYS 30 dosimetry system, available for customers.

GEX barcode scanner for DoseControl	Click link to download
DoseControl integrated barcode scanner	Integrated Barcode Scanner IQOQ Procedure – GEX Doc. No. 100-278. (Use with Form Doc. #100-279) Integrated Barcode Scanner IQOQ Test Form (MS Word) – GEX Doc. No. 100-279. (For use with Integrated Barcode Scanner IQOQ Procedure Doc. No.100-278)

GEX barcode scanner for DoseControl

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DoseControl integrated barcode scanner

Integrated Barcode Scanner IQOQ Procedure – GEX Doc. No. 100-278. (Use with Form Doc. #100-279)

Integrated Barcode Scanner IQOQ Test Form (MS Word) – GEX Doc. No. 100-279. (For use with Integrated Barcode Scanner IQOQ Procedure Doc. No.100-278)

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