Cleaning Residue Limits Based on Actual Shared Surface Area
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Solution Overview
Problem
Conventional product manufacturing cleaning technologies overestimate the surface area shared between the product and the cleaning agent, leading to excessively stringent MACO values, which results in excessive use of cleaning resources and environmental hazards due to solvent use.
Innovation Solution
A cleaning validation system determines the actual surface areas shared between the product and the cleaning agent, calculating a more accurate cleaning agent residue limit, reducing the need for excessive cleaning resources and minimizing solvent use.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional technologies use total surface area to calculate MACO value, then cleaning validation is performed, but the MACO value is excessively stringent leading to excessive cleaning resource consumption
Solution Approach 1:
The patent replaces the conventional mechanical/calculation-based total surface area measurement with a vision-based measurement system using cameras and image processing algorithms. This substitution enables accurate identification of actual shared surface areas through digital imaging and computational analysis, resolving the contradiction by providing precise measurement without excessive resource consumption.
Solution Approach 2:
The patent creates a digital copy or representation of the equipment surface through imaging technology. By capturing images and processing them to identify shared surface areas, the system works with a digital replica rather than physically measuring or cleaning the entire surface, thereby reducing actual cleaning resource consumption while maintaining validation reliability.
2Reliability
If conventional technologies use solvents to clean equipment, then cleaning agent residue is avoided, but environmental hazards and disposal costs increase
Solution Approach 1:
The patent changes the fundamental parameter of cleaning validation from residue detection to surface area measurement. By determining the actual shared surface area between equipment and cleaning agent, the system calculates appropriate MACO values that allow water-based cleaning agents to be used effectively, eliminating the need for hazardous solvents while maintaining residue control through accurate measurement rather than aggressive cleaning.
3Reliability
If conventional technologies use excessive cleaning resources to meet stringent MACO values, then cleaning validation is achieved, but cost and time increase
Solution Approach 1:
The patent performs preliminary measurement of the shared surface area using imaging technology before the cleaning process. By knowing the actual shared surface area in advance, the system can calculate the appropriate MACO value and design an optimized cleaning process that meets validation requirements without excessive resource consumption, saving time and costs associated with trial-and-error cleaning approaches.
Data Source
AI summary
Residual limit determination for a cleaning agent corresponding to a validation of an equipment cleaning process is presented herein. A system determines a cleaning agent for cleaning a group of equipment to be used to manufacture a product; and determines a sum of surface areas of respective surfaces of respective groups of parts of the group of the equipment that have been determined to be contacted by the product and the cleaning agent. Based on the sum of surface areas of the respective surfaces that have been determined to be contacted by the product and the cleaning agent, the system determines a cleaning agent residue limit representing a threshold maximum allowable residue of the cleaning agent to be present after the cleaning process has been performed on the group of equipment, and facilitates a cleaning validation of the cleaning process according to the cleaning agent residue limit.