Disposable Radiopharmaceutical Synthesis Module for Contamination Control
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Solution Overview
Problem
The synthesis of radiopharmaceutical products using radioactive elements with short half-lives poses challenges due to contamination risks, complex and costly equipment, and the need for frequent maintenance and sterilization of sensitive components.
Innovation Solution
A device comprising a fixed module with mechanical means and a removable, disposable module with pre-metered bottles and flexible tubes, allowing for easy assembly, precise positioning, and automated actuation, which can be sterilized by steam autoclaving, minimizing contamination and maintenance efforts.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If reusable synthesis apparatus with valves and tubes is used, then synthesis capability is maintained, but contamination risk increases and maintenance complexity increases
Solution Approach 1:
The patent implements a disposable single-use module containing all transfer tubes, valves, and reagent containers that are discarded after one synthesis cycle. This eliminates contamination risk from reusable components while avoiding the maintenance complexity of sterilizing sensitive radiochemical components. The fixed module with reusable mechanical means and reaction vessels maintains synthesis capability without requiring sterilization of radiochemical-sensitive parts.
Solution Approach 2:
The synthesis apparatus is divided into two distinct modules: a fixed reusable module containing mechanical means and reaction vessels, and a disposable single-use module containing transfer tubes, valves, and reagent containers. This segmentation allows the disposable portion to be discarded after use, eliminating contamination risks, while the fixed portion can be reused without sterilization of radiochemical-sensitive components.
2Measurement precision
If complex metering means with stepping motors are used, then precise reagent transfer is achieved, but device complexity and cost increase
Solution Approach 1:
The patent extracts the complex metering mechanism (stepping motors and piston injectors) from the system and replaces it with pre-filled sealed reagent containers. The disposable module includes pre-metered reagents in sealed ampoules or cartridges that are simply connected to the reaction vessel, eliminating the need for complex motorized metering while maintaining precise reagent delivery.
Solution Approach 2:
Reagents are pre-filled and pre-metered into sealed containers during manufacturing before use. The disposable module arrives ready-to-use with precise amounts of reagents already prepared, eliminating the need for complex on-site metering mechanisms and reducing device complexity while maintaining measurement precision.
3Ease of manufacture
If reusable components are used, then cost is reduced, but sterilization frequency and maintenance effort increase
Solution Approach 1:
The patent uses inexpensive disposable components (tubes, valves, containers) that are discarded after single use rather than being sterilized and maintained. This eliminates the time-consuming sterilization process and maintenance efforts while keeping the overall cost low through the use of simple, mass-producible plastic components.
Solution Approach 2:
The disposable module is discarded after one use rather than being cleaned and sterilized. This eliminates maintenance effort and sterilization frequency requirements. The system recovers by simply replacing the disposable module with a new one, which is faster and more reliable than sterilization processes.
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 device reduces contamination risks, simplifies maintenance, and allows for cost-effective single-use kits, enhancing safety and operational efficiency in synthesizing radiopharmaceuticals like 18FDG while reducing the volume of shielded areas.
Implementation Method 1
mechanical means acting on the transfer means and enabling to monitor and control mechanically the transfer of the chemical reagents
Implementation Method 2
The support plate and that of the transfer means are preferably such that they allow washing of the said disposable module by steam autoclaving and/or its sterilisation
Data Source
AI summary
The invention concerns a device for synthesis of radiopharmaceutical products based on chemical reagents contained in bottles, said device comprising several reaction compartments, transfer means between said bottles and said reaction compartments as well as mechanical means acting on said transfer means and enabling to monitor and control mechanically the transfer of chemical reagents. The invention is characterized in that it comprises: a fixed module including at least the mechanical means; a removable and disposable module, essentially in the shape of a support, whereon are arranged the transfer means between said bottles and said reaction compartments, said removable and disposable module not including any mechanical means; and means for securing said removable and disposable module to said fixed module.