Biocontainer Radiation Dose Sensor Segmentation
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Solution Overview
Problem
The use of single-use biocontainers in biopharmaceutical applications poses challenges due to variations in radiation dose distribution during sterilization, which can cause chemical reactions and modifications in plastic materials, affecting the stability and quality of products stored within, and existing methods lack accurate measurement of radiation doses for individual biocontainers.
Innovation Solution
Implementing a method where each biocontainer is equipped with a radiation dose sensor to accurately measure the absorbed radiation dose, allowing for the calculation of an ageing time to prevent use until the material has stabilized, thereby predicting and minimizing the impact on product quality.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If single-use biocontainers are used to eliminate cleaning validation processes, then productivity and resource utilization are improved, but measurement precision of radiation dose for individual containers deteriorates
Solution Approach 1:
The patent divides the measurement system into individual units by placing a separate radiation dosimeter with each single-use biocontainer. This segmentation allows independent measurement of radiation dose for each container, resolving the contradiction between using single-use containers (which improves productivity) and accurately measuring radiation dose (which requires individual monitoring of each container rather than bulk measurement)
Solution Approach 2:
The patent introduces radiation dosimeters as intermediary devices that measure the radiation dose absorbed by each biocontainer. These dosimeters act as mediators between the radiation source and the containers, providing quantitative data about the actual dose received by each individual container, thereby enabling precise measurement control while maintaining the single-use container system
2Device complexity
If radiation dosimeters are placed only at outer periphery of container, then device complexity is reduced, but measurement precision of radiation dose distribution deteriorates
Solution Approach 1:
The patent segments the measurement system by placing multiple dosimeters at different locations within the container (including center, corners, and surfaces) rather than using a single peripheral dosimeter. This spatial segmentation provides comprehensive data on radiation dose distribution throughout the container volume, resolving the contradiction between simple device configuration and accurate measurement of dose distribution variations
3Ease of operation
If indicator tags are used to verify radiation exposure, then ease of operation is improved, but measurement precision of radiation dose deteriorates
Solution Approach 1:
The patent replaces qualitative indicator tags with quantitative radiation dosimeters as intermediary measurement devices. The dosimeters provide numerical data on the actual radiation dose absorbed by each container, enabling precise measurement and control while maintaining ease of operation through automated or semi-automated reading of the dosimeter values
Solution Approach 2:
The patent substitutes the mechanical/chemical indicator tag system with electronic or optical dosimeter systems that provide quantitative measurements. This replacement maintains operational simplicity while dramatically improving measurement precision, as electronic/optical sensors can provide accurate numerical data on radiation dose rather than only qualitative indication
4Loss of substance
If multiple-use containers are sterilized and reused, then loss of substance is reduced, but object-generated harmful factors increase due to contamination risk
Solution Approach 1:
The patent adopts single-use biocontainers as disposable items that are sterilized by radiation and then discarded after use. This eliminates the need for cleaning and validation processes associated with reusable containers, thereby reducing contamination risk while the low cost and single-use nature minimize loss of substance through proper disposal and no need for cleaning chemical waste
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
This approach enables more precise control over the sterilization process, ensuring the quality and shelf life of products by accurately measuring radiation doses for each biocontainer, reducing the risk of product degradation and contamination.
Implementation Method 1
The sterilization is achievable through ionizing irradiations as γ-rays, e-beam, X-rays that penetrate through parts, plastic or metallic parts, to sterilize the parts by killing microorganisms on or within the parts.
Implementation Method 2
A radiation dosimeter is a device that when irradiated, exhibits a quantifiable change in some property of the radiation dosimeter which can be related to an absorbed dose in a given material.
Data Source
AI summary
A method of sterilizing biocontainers including irradiating a biocontainer and measuring a radiation dose received by the biocontainer. The method also includes determining an ageing time of the biocontainer after irradiation based on the radiation dose received by the biocontainer and preventing use of the biocontainer before the ageing time has elapsed.