Sterilization Effectiveness Simulation Using 3D Grid Modeling
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Solution Overview
Problem
Current methods for determining the effectiveness of sterilization processes for medical devices are labor-intensive, require sample evaluation, and struggle to accurately assess sterility in complex geometries, especially when multiple media are involved, leading to potential distortion and inefficiencies.
Innovation Solution
A computational process using a three-dimensional grid to recreate the medical device and sterilizer, simulating temperature, media quantities, and germ loading changes during sterilization, allowing for accurate calculation of germ reduction across all cells and surfaces, including consideration of media interactions and phase transitions.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If physical samples are introduced into the medical device for sterilization validation, then the effectiveness of the sterilization process can be determined, but the device complexity increases and the ease of operation decreases due to difficult sample introduction and evaluation
Solution Approach 1:
The patent creates a digital copy (computational model) of the medical device and sterilization process, replacing physical samples with virtual simulations. The computational model replicates the device geometry, material properties, and sterilization media behavior to predict sterilization effectiveness without requiring physical sample introduction or laboratory evaluation
Solution Approach 2:
The patent replaces the mechanical and biological system of physical sampling (introducing strips, incubating in culture media, evaluating germ growth) with a computational system that uses numerical methods to simulate heat transfer, media distribution, and sterilization kinetics, thereby eliminating the need for physical sample handling and laboratory procedures
2Measurement precision
If incubation in culture medium is performed to evaluate remaining germs, then the measurement precision of germ load is improved, but the loss of time increases due to several days of incubation required
Solution Approach 1:
The patent performs preliminary computational calculations of sterilization effectiveness before any physical sterilization takes place. By using the computational model to predict the sterilization outcome based on process parameters and device geometry, the need for time-consuming post-sterilization incubation and evaluation is eliminated, as the effectiveness is determined in advance through simulation
3Measurement precision
If samples are introduced into sealed volumes or thin channels of the medical device, then the sterilization effectiveness at critical points can be assessed, but the device complexity increases and accessibility decreases making sample introduction difficult or impossible
Solution Approach 1:
The patent creates a detailed digital replica of the medical device including all sealed volumes, thin channels, and complex geometries. This computational model allows the simulation of sterilization media flow and heat transfer to critical points that are inaccessible to physical samples, enabling effectiveness assessment without requiring physical sample introduction into difficult-to-reach areas
4Reliability
If physical samples are used to validate sterilization processes, then the reliability of sterilization can be confirmed, but the productivity decreases due to the labor-intensive and time-consuming evaluation process
Solution Approach 1:
The patent replaces the manual, labor-intensive physical sampling and laboratory evaluation system with an automated computational system. The software performs rapid numerical simulations of sterilization processes, providing immediate results without requiring manual sample handling, incubation monitoring, or laboratory analysis, thereby dramatically improving validation productivity while maintaining reliability
Solution Approach 2:
The computational model is self-sufficient in determining sterilization effectiveness without requiring external laboratory resources. The system automatically calculates sterilization outcomes based on input parameters and device geometry, eliminating the need for external validation services and enabling rapid, in-house process verification
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 efficient determination of sterilization effectiveness without physical samples, allowing for optimization of device design and process parameters, and simplifies validation, reducing time and effort while ensuring accurate sterility assessment.
Implementation Method 1
recreating, step by step, changes in temperature, in the quantity of a first medium and in the quantity of a second medium occurring in each cell of the second multiplicity of cells during the sterilization process
Implementation Method 2
calculating a reduction in a germ loading achieved in each cell of the second multiplicity of cells during the sterilization process taking into consideration the prevailing temperature, quantity of the first medium and quantity of the second medium in the respective cell in each step
Data Source
AI summary
A process is presented for determining the effectiveness of sterilizing processes for medical devices with the following steps: providing a data structure, wherein the data structure represents a grid formed of a plurality of three-dimensional cells; recreating the medical device arranged in the sterilizer in the data structure in such a way that a first multiplicity of cells of the grid represent a body of the medical device and that a second multiplicity of cells represent an interior of the sterilizer which is not occupied by the body of the medical device; recreating an initial state in the data structure in such a way that each cell of the second multiplicity of cells is assigned data relating to the temperature prevailing at the location of the cell, the quantity of a first medium located in the area of the cell, and the quantity of a second medium located in the area of the cell; recreating, step by step, changes in the temperature, in the quantity of the first medium and in the quantity of the second medium occurring in each cell of the second multiplicity of cells during the sterilization process; and calculating a reduction in a germ loading achieved in each cell of the second multiplicity of cells during the sterilization process taking into consideration the prevailing temperature, quantity of the first medium and quantity of the second medium in the respective cell in each step. Furthermore, a data processing system and a computer program product for carrying out the process are presented.