Gamma Spectroscopy Application
The Apex-Guard application is an advanced gamma spectroscopy solution designed to meet the stringent demands of regulated count rooms. It provides defensible and ready-to-use impurity calculations and reporting, enabling radioisotope producers to reliably fulfill regulatory requirements such as U.S. FDA 21 CFR Part 11**, and elevate the overall quality of radioisotope production.
The Apex-Guard gamma spectroscopy application builds on Genie™ and Apex-Gamma™ software to provide enhanced controls, security, audit features, and data integrity to support compliance and quality needs of regulated count rooms.
Radioisotope producers for radiopharmaceutical applications routinely perform quality assurance measurements to demonstrate the radionuclidic purity (RNP) of their products. In gamma spectroscopy, this is achieved by evaluating the sample for impurities and demonstrating the impurities are below a percentage of the total sample activity. To accomplish this with reliability and confidence, the Apex-Guard software impurity analysis algorithm* evaluates the activity of any defined impurity radionuclide against the activity of the sample, which can be compared to a user-defined limit.
The reference sample activity can be defined in a number of ways, including externally-reported activity or from the same gamma spectroscopy measurement. For both the sample activity and the impurity activity, the Apex-Guard impurity algorithm accounts for measurement uncertainties and introduces a new metric — Maximum Potential Percent Impurity (MPPI) — providing defensible, confident reporting of the sample’s radionuclidic impurity.
*The Apex-Guard software impurity analysis algorithm is patent-pending.
**Apex-Guard Software and Mirion’s IQ/OQ Service are designed to ensure customers can meet Title 21 CFR Part 11 readily and easily. Please note that Apex-Guard software as a standalone product is not Part 11 compliant and must be integrated with processes and procedures for laboratory Part 11 compliance.
The impurity algorithm divides the probability distribution of the impurity activity by the probability distribution of the sample activity, and then identifies a value that is the highest likely percentage (based on a user-defined confidence) of the true impurity activity to the true total sample activity. This percentage is called the Maximum Potential Percent Impurity, or "MPPI".
This method is effective for both identified and unidentified radionuclide impurities. In cases where no peak is found, the MPPI reflects the sensitivity of measurement setup, preventing false reporting of a radionuclide below the below the configured limit.
The Apex-Guard Impurity Report enables users to set impurity limits for individual radionuclides and for the total impurity activity in the sample. These limits are displayed alongside the MPPI value for each impurity for easy understanding of results. The report displays activity, minimum detectable activity (MDA) divided by reference activity (which could be the total sample activity or the primary radionuclide activity, for example), and MPPI for each radionuclide.
A secondary detail impurity report shows information for each radionuclide emission line, useful for evaluating the spectrum analysis and performing additional investigation, if needed.
Apex-Guard is available as a subscription service, combining priority technical support, software updates, and annual or three-year license terms. Mirion Support assists in planning, implementing, and optimizing your operations. With the Apex-Guard application, rely on Mirion Services for:
As radiopharmaceuticals transform healthcare by improving early diagnosis and patient outcomes, Mirion remains committed to partnering with our Radiopharmaceutical production customers to enable continued innovation while maintaining radiation safety standards.
Enhance your operational efficiency with Mirion's gamma spectroscopy solutions, grounded in deep expertise and continuously enhanced through investments in research and development.
Apex-Guard software is designed to advance gamma spectroscopy and maintain compliance in highly regulated count room environments. Learn more about Mirion’s cybersecurity-focused product development strategy that drives hardware and software synergy, future-readiness and security.
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