Leak Test Reliability via Volume and Temperature Deviation Compensation
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Solution Overview
Problem
Conventional integrity and leak tests in the pharmaceutical and biotechnology industries face reliability issues due to unaccounted volume changes and temperature deviations, which can lead to false test results, potentially endangering patient safety.
Innovation Solution
A computer-implemented method and system that determine parameters indicative of the sample's volume and temperature changes, assessing the impact of these deviations on test results, and correcting or generating error messages to ensure accurate integrity or leak test assessments.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional integrity or leak tests are performed without accounting for volume changes and temperature deviations, then the test procedure is simple and quick, but the reliability of the test results deteriorates due to false indications
Solution Approach 1:
The system performs preliminary determination of volume parameters and temperature conditions before conducting the integrity or leak test. By establishing baseline values and detecting deviations in advance, the system compensates for environmental influences on the test results, thereby improving reliability without significantly increasing operational complexity
Solution Approach 2:
The system continuously monitors temperature and volume parameters during the test procedure and uses this feedback to adjust or correct test indications. When deviations from expected parameters are detected, the system can compensate for their influence on the test results, ensuring more accurate pass/fail determinations
2Stability of the object's composition
If the test period is extended to allow for temperature stabilization, then temperature deviations during testing are reduced, but the test duration increases
Solution Approach 1:
The system performs preliminary temperature assessment and volume determination before the actual integrity test. By detecting temperature conditions and volume parameters in advance, the system can compensate for thermal effects during the test without requiring extended stabilization periods, thus maintaining test speed while improving temperature stability
Solution Approach 2:
The system changes the approach from waiting for temperature stabilization to actively measuring and compensating for temperature and volume parameters. By determining these parameters before and during the test, the system accounts for thermal expansion and contraction effects, achieving stable results without extending the overall test duration
3Measurement precision
If volume changes of the sample are not compensated for, then the test procedure remains simple, but the accuracy of integrity assessment deteriorates
Solution Approach 1:
The system determines volume parameters before conducting the integrity test to establish a baseline. By knowing the initial volume state and monitoring changes during testing, the system can compensate for volume-related effects on pressure measurements, thereby improving assessment accuracy without significantly complicating the procedure
Solution Approach 2:
The system introduces volume determination as an intermediary measurement that connects temperature/pressure readings to integrity assessment. By using volume parameters as a mediator to account for thermal expansion and material property changes, the system achieves more precise integrity evaluation while maintaining procedural simplicity
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
Enhances the reliability of integrity and leak tests by accurately accounting for volume and temperature changes, reducing the risk of false test results and improving quality assurance.
Implementation Method 1
Volume changes of the sample may result from expansion or contraction of the material with which the sample is made, e.g. plastic such as polypropylene, ethylene vinyl acetate copolymer (EVA), ethyl vinyl alcohol (EVOH) or polyethylene
Data Source
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AI summary
According to an aspect, a computer implemented method, a computer system and a computer program product for improving the reliability of an integrity or a leak test of a sample are provided. The method comprises determining at least one first parameter indicative of at least one of the following: a first volume of the sample, a first temperature of the sample, a first pressure of the sample and a first assessment of the integrity of the sample. The at least one first parameter is determined under specified temperature conditions. The method further comprises determining at least one second parameter indicative of a deviation from the first parameter. The method further comprises determining, after determining the at least one second parameter, at least one third parameter indicative of a second assessment of the integrity of the sample, wherein the second assessment provides an indication of a passed test or a failed test. The method further comprises determining whether the deviation has an impact on the indication of the second assessment. When the deviation is determined to have an impact on the indication of the second assessment, the method further comprises identifying a possibility that the indication of the second assessment is incorrect.