Reusable Fluid Path Cleaning for Hyperpolarization
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Solution Overview
Problem
Current systems for hyperpolarization of pharmaceutical products using dynamic nuclear polarization (DNP) are costly, leading to limited use due to the high cost per measurement, and they require single-use fluid path systems that are prone to contamination, increasing health risks and logistical challenges.
Innovation Solution
A method for cleaning and reusing fluid path systems for hyperpolarization, which involves transferring a cleaning medium through the system, ejecting it, and drying the system to ensure sterility and prevent contamination, thereby reducing costs and logistical complexities.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Object-affected harmful factors
If single-use fluid path systems are used for hyperpolarization, then contamination risk is reduced, but cost per measurement increases and logistical complexity increases
Solution Approach 1:
The patent implements a cleaning and sterilization process that recovers the fluid path system for reuse. The system is cleaned with cleaning agents, sterilized using methods such as autoclaving or chemical sterilization, and then reused for subsequent hyperpolarization measurements, transforming a single-use system into a reusable one while maintaining safety standards
Solution Approach 2:
The fluid path system is designed to be self-contained and self-sterilizable, with integrated sterilization chambers and cleaning protocols that allow the system to maintain its own sterility without requiring external intervention for each use, reducing logistical burden
2Object-affected harmful factors
If single-use fluid path systems are used forhyperpolarization, then contamination risk is reduced, but cost per measurement increases
Solution Approach 1:
The fluid path system is designed for multiple uses through implemented cleaning and sterilization protocols. After each hyperpolarization measurement, the system undergoes a standardized cleaning process using chemical agents followed by sterilization, allowing it to be reused numerous times, thereby amortizing the initial cost over many measurements and reducing the cost per measurement
Solution Approach 2:
The system maintains sterility by changing physical parameters such as temperature (autoclaving at high temperature) and chemical concentration (sterilizing agents), transforming the system from a potentially contaminated state to a sterile state for reuse, eliminating the need for disposable single-use systems
3Quantity of substance
If reusable fluid path systems are implemented, then cost per measurement decreases, but contamination risk increases
Solution Approach 1:
The system performs preliminary cleaning and sterilization actions before each hyperpolarization measurement. The fluid path system is pre-cleaned with appropriate agents and pre-sterilized using autoclaving or chemical methods before being connected to the hyperpolarization apparatus, ensuring it starts in a sterile state for each use
Solution Approach 2:
The sterilization and cleaning process is made continuous and integral to the operational cycle of the fluid path system. Rather than being a separate discontinuous step, the cleaning and sterilization are built into the workflow between measurements, ensuring continuous maintenance of sterility and eliminating gaps where contamination could occur
Data Source
AI summary
A method is provided for cleaning a reusable fluid path system for hyperpolarization of a pharmaceutical product, the system being continuously at least partly contained by a polarizer. The steps include: providing the polarizer with an inlet tube having a first inlet tube end for fluid contact with a fluid vessel and a second inlet tube end for fluid contact with a vial, for holding the pharmaceutical product; providing the polarizer with an outlet tube having a first outlet tube end for receiving the vial and a second outlet tube end for connecting to a receiving vessel; sealing the second inlet end with the first outlet end; fluidly connecting a medium vessel to the first inlet end; fluidly connecting a collector vessel to the second outlet end; cleaning the path system by transferring cleaning medium from the vessel into the system; ejecting the cleaning medium; and drying the path system.