Automated Analyzer for Quantitative Cleaning Validation
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Solution Overview
Problem
Current methods for validating the cleanliness of surfaces after the cleaning process, such as the riboflavin test, lack quantitative proof of the removal of potent or sensitizing substances, leaving room for hygiene and cross-contamination risks, particularly in the pharmaceutical industry.
Innovation Solution
A method involving a coating device with a test liquid containing simulated chemical and/or microbiological contaminants, applied to a defined test area, followed by a standardized cleaning process and verification using an analyzer to determine the presence of residues, ensuring a high level of cleanliness.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If visual inspection using black light and telescoping mirror is used to verify cleaning effectiveness, then the inspection process is simple and quick, but quantitative proof of contaminant removal is not provided
Solution Approach 1:
The patent replaces manual visual inspection methods (black light and telescoping mirror) with an automated analyzer system that provides quantitative measurement. The analyzer objectively measures contaminant levels on surfaces, substituting the subjective mechanical inspection process with an automated analytical system that delivers precise numerical data about cleaning effectiveness.
Solution Approach 2:
The patent introduces simulated contaminants as an intermediary substance to enable quantitative verification. These simulated contaminants serve as test agents that allow the analyzer to measure and quantify actual contaminant removal effectiveness, bridging the gap between visual inspection and precise measurement.
2Measurement precision
If simulated contaminants and analyzers are used to provide quantitative verification, then measurement precision is improved, but device complexity and cost increase
Solution Approach 1:
The patent uses simulated contaminants as copies or analogs of real contaminants. These simulated substances replicate the properties and behavior of actual contaminants but are designed to be easily detected and measured by the analyzer, providing a simplified model system that maintains measurement precision while reducing the complexity of working with actual potent or sensitizing substances.
3Adaptability or versatility
If manual inspection by technicians is used, then adaptability to different surface areas is maintained, but reliability and sensitivity of validation are reduced
Solution Approach 1:
The patent enables the verification system to perform its own validation objectively through automated analysis. The analyzer independently measures contaminant levels without requiring human judgment or interpretation, allowing the system to self-validate cleaning effectiveness with consistent, reliable, and sensitive quantitative measurements across different surface areas.
Data Source
AI summary
The invention relates to a method for verifying the result of a process of cleaning simulated chemical and/or microbiological contamination applied beforehand to a test area, in particular for the validation process for automated washing system functions. The method comprises the following steps: —providing a coating device having a filled cartridge, which contains a test liquid for simulating chemical and/or microbiological contamination. The test liquid contains a defined type and concentration of chemically and/or microbiologically contaminating substances; —selecting a defined test area and applying a defined amount of test liquid to the test area; —carrying out a standardised process of cleaning the test area provided with the test liquid; and—finally verifying and logging the result of the cleaning process carried out.