Shielded Radiopharmaceutical QC Automation With 3D Pipetting
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Solution Overview
Problem
Existing quality control methods for radiopharmaceuticals are time-consuming, prone to human error, and expose operators to radiation, lacking integrated and automated systems that meet regulatory standards and ensure reproducibility and safety.
Innovation Solution
A shielded apparatus with integrated analytical equipment for non-destructive and destructive tests, including GC, gamma spectrometry, and HPLC, along with a data management system, ensures automated and standardized quality control of radiopharmaceuticals, minimizing operator exposure and ensuring compliance with regulatory standards.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If manual quality control methods are used for radiopharmaceuticals, then operators can perform inspections and tests, but the process becomes time-consuming and prone to human error
Solution Approach 1:
The system enables automated self-service quality control through robotic manipulation that autonomously performs sample preparation, injection, and analysis without human intervention. The robotic system automatically handles multiple QC tests including HPLC, GC, and radiochemical analysis, eliminating manual operations while maintaining high precision and reducing time loss through continuous automated processing.
Solution Approach 2:
Manual mechanical operations are replaced with an integrated robotic system that combines automated liquid handling, precise injection mechanisms, and coordinated instrument operation. The robotic manipulator replaces human hands for all sample handling tasks, while automated control systems replace manual decision-making processes, achieving both higher precision and faster throughput.
2Productivity
If operators work in parallel on different equipment for radiopharmaceutical QC, then multiple parameters can be tested, but operator exposure to radiation increases
Solution Approach 1:
The robotic system serves as an intermediary between the operator and radioactive samples, allowing operators to control multiple QC instruments remotely without direct exposure to radiation. The robot autonomously handles all sample manipulation, injection, and analysis tasks across HPLC, GC, and radiochemical equipment, maintaining high productivity while eliminating radiation exposure for human operators.
Solution Approach 2:
The system performs self-service quality control by autonomously coordinating multiple analytical instruments and performing all testing operations without human intervention in the radiation zone. The robotic system independently manages sample preparation, instrument operation, and data collection, enabling high-throughput multi-parameter testing while keeping operators completely outside the radiation field.
3Reliability
If automated quality control systems are implemented, then human error is reduced, but the device complexity increases
Solution Approach 1:
Multiple separate quality control instruments and operations are merged into a single integrated robotic system. The system combines HPLC, GC, radiochemical analysis, and sample preparation functions into one coordinated platform, reducing device complexity by eliminating the need for multiple independent systems while maintaining high reliability through unified automated control.
Solution Approach 2:
The robotic system performs multiple quality control functions through a single universal platform, handling diverse analytical tasks including chromatography, spectroscopy, and radiochemical testing. This multi-functional approach reduces overall system complexity by replacing numerous specialized devices with one adaptable robotic system capable of performing all required QC operations.
4Stability of the object's composition
If integrated automated QC systems are used, then reproducibility and standardization are improved, but the initial setup and complexity increase
Solution Approach 1:
The system incorporates preliminary calibration and standardization procedures that are automatically performed during setup and maintained throughout operation. Reference standards, calibration curves, and method parameters are pre-configured and automatically applied, ensuring reproducible results from the first analysis. The robotic system pre-establishes all operational parameters and quality control criteria before beginning testing sequences.
Solution Approach 2:
The system maintains reproducibility by precisely controlling and standardizing all operational parameters including injection volumes, flow rates, detection settings, and analysis conditions. Automated parameter management ensures consistent operation across all tests and days, while the robotic system dynamically adjusts parameters based on pre-programmed methods and real-time feedback, achieving high reproducibility without manual intervention.
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
The apparatus provides rapid, reliable, and reproducible quality control of radiopharmaceuticals, reducing human error and radiation exposure while adhering to regulatory requirements, enabling comprehensive analysis of various parameters from a single sample.
Implementation Method 1
radioactivity measurement: utilizing detectors such as gamma counters or scintillation counters to measure radioactivity levels accurately but also being able to differentiate energy levels for gamma spectroscopy
Implementation Method 2
chemical analysis: techniques such as high performance liquid chromatography (HPLC), gas chromatography (GC), mass spectrometry (MS)
Implementation Method 3
chemical analysis: techniques such as high performance liquid chromatography (HPLC), gas chromatography (GC), mass spectrometry (MS)
Implementation Method 4
chemical analysis: techniques such as high performance liquid chromatography (HPLC), gas chromatography (GC), mass spectrometry (MS)
Implementation Method 5
non-destructive measurements such as those carried out by automated colourimetric systems directly on the sample through an optically transparent container, that may incorporate spectrophotometers, colourimeters, or other optical instruments capable of accurately measuring and analysing colour/ clarity properties
Data Source
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AI summary
The present invention relates to a shielded apparatus for automated and integrated quality control, in short QC, analysis of a radiopharmaceutical compound, wherein said shielded apparatus has in a front part thereof two entry ports (3, 4) configured to receive a sample loader (5) and a consumable loader (6) respectively, wherein said sample loader (5) is a shielded holder configured to host a vial (74), preferably an optical cuvette, with a sample to be analysed, wherein said consumable loader (6) is a tray-shaped organizer containing in use a reagent block (71) provided with reagents, reference standards and other disposables, a migration chamber with a TLC strip (72), a plurality of disposable tips (73), all necessary to the performance of the above-mentioned analyses, and wherein it contains inside the core module (1) a 3D pipettor (8) cooperating with the disposable tips (73) for performing four different types of fluid transfer, respectively from sample to consumables (81), from sample to analytical equipment (83), from reference standards to consumables (82) and from reference standards to analytical equipment (84).