Aer ODE B3-20. Database System for GEX B3 Dosimetry. Aérial. Optical Dosimetry Equipment. (gamma and/or electron beam versions)

Transcription

1 B3-20 Database System for GEX B3 Dosimetry (gamma and/or electron beam versions)

2 and GEX combine to provide a Genesys 20 version of the flexible 21 CFR Part 11 certified database dosimetry system for use with GEX dosimeter products.

3 has provided the radiation processing community with a dedicated dosimetry system called for more than 15 years. GEX introduced its Risø B3 radiochromic film based WINdose and DoseStix dosimeter product line in The dosimetry system was developed by to satisfy the needs for certified dosimetry in the radiation processing applications such as medical device sterilization, food irradiation, etc. and has been n certified compliant with CFR 21 Part 11 software requirements. developed an compatible version for use with factory- packaged, application specific GEX B3 WINdose and DoseStix dosimeter products and Genesys 20 spectrophotometers.

4 B3-20 Features Large Established Standardized Software User Base Certified 21 CFR Part 11 Compliant Software User Specified Adaptable Interface Well Documented, Design Controlled Easy to Use On-site Installation and Training Available Continuous Technical Support (web-based) based) Continuous Improvement with Pre-Validated Revision Upgrades

5 Dosimetry Lab IQ/OQ/PQ Dosimetry Routine Dosimetry Production Radiation process parameters Quality Assurance Dept. Performance Qualification Parameters Loading Pattern Validation Certificate Server Dosimetry Data Base Oracle, MySQL,, Access Plant Data Base Certification

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7 Uses software version 4 Customer s s Microsoft Windows based PC Genesys 20 Spectrophotometer Reference filters (national standard traceable) GEX B3 WINdose and/or DoseStix dosimeter holder(s) GEX B3 post-irradiation heat treatment system Equipment validation certificate and user manual GEX B3 Dosimetry Procedure Package GEX Hands-On Dosimetry Workshop Discount

8 Genesys 20 version is optimized for use with GEX B3 DoseStix and WINdose dosimeters

9 Software Description: Controls equipment settings, measurement readings and storage of data in a Database User profiles, process validations (loading pattern, plans definition, report edition, etc.) - Performs equipment verifications (Absorbance, Wavelength, Thickness) needed to certify the absorbed dose measurements - Records B3 dosimeter barcodes with measurement results. B3-20 systems are set up and customized according to customer specific requirements.

10 User Login with Controlled Functions Access Uses GEX Calibration Coefficients or can be equipped with a calibration curve fitting feature Measurement Equipment Verification IQ/OQ/PQ Dosimetry Measurements Routine Dosimeter Measurements User Customized Dosimetry Reports Maintains Activity History Log

11 The equipment is validated and meets the quality assurance requirements according to FDA Part 11, ISO, EN, and ASTM guidance or standards. is designed to integrate efficiently with your plant network and the software can be adapted to communicate and record data from multiple instrument setups. is a flexible, complete, and professional tool for certified industrial dosimetry.

12 User Specific Access Level Authorization Example

13 Dosimeter Batch Specific Calibration Record

14 Software Activity Record Log

15 Instrument Wavelength Accuracy Check

16 Instrument Absorbance Accuracy Check

17 Dosimeter Measurement Log

18 Operational (OQ) and Performance Qualification (PQ) Option

19 Develop Optimum Product Loading Patterns

20 Establish Dosimeter Map Placement Locations

21 Electron Beam Installation (IQ) and Operational Qualification (OQ)

22 Depth/Dose Energy Measurement

23 Scan and Travel Uniformity Measurement