Cleaning Residue Limit Calculation Using Shared Contact Surface Area
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Solution Overview
Problem
Conventional product manufacturing cleaning technologies overestimate the surface area shared between equipment and cleaning agents, leading to excessively stringent residual limit calculations, resulting in inefficient use of resources and environmental hazards due to excessive solvent use.
Innovation Solution
A cleaning validation system that determines the sum of surface areas of defined equipment parts contacted by products and cleaning agents to calculate a more accurate residual limit for cleaning agents, reducing resource consumption and solvent usage.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If the total surface area of the equipment is used to calculate the MACO value, then the calculation is simple, but the MACO value becomes excessively stringent and does not reflect the actual shared surface area
Solution Approach 1:
The equipment surface is segmented into distinct zones: product-contact surfaces, cleaning agent-contact surfaces, and shared surfaces. By dividing the total surface area into these functional segments, the patent calculates MACO based only on the shared surface area where both product and cleaning agent come into contact, rather than using the total equipment surface area. This segmentation approach improves measurement precision while maintaining reasonable calculation complexity through systematic classification.
2Reliability
If excessive cleaning resources are used to meet stringent MACO values, then cleaning agent residue is reduced, but resource consumption and costs increase
Solution Approach 1:
The patent changes the critical parameter from total surface area to shared surface area in the MACO calculation. This parameter change results in a less stringent (higher) MACO value that reflects actual contamination risk, thereby reducing the amount of cleaning resources required while maintaining adequate cleaning effectiveness and product safety.
3Reliability
If solvents are used to rinse equipment after cleaning, then cleaning agent residue is removed, but solvent usage costs and environmental hazards increase
Solution Approach 1:
By changing the MACO calculation parameter from total surface area to shared surface area, the patent establishes a more realistic residue limit that eliminates the need for excessive solvent rinsing. The revised MACO value accounts for the actual shared contact area, allowing water-based cleaning to achieve compliance without requiring additional solvent-based rinsing steps, thereby reducing environmental hazards.
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.