Automated Leak Testing: Accuracy, Repeatability and Total Control in a Critical Medical Process

Industry: Medical

Summary

The traditional leak detection method—submerging the product in water, injecting air, and visually assessing for bubbles—limited accuracy, relied on operator judgment, and did not generate quantitative data for analysis or traceability.
CIP developed a high-precision automated leak testing system, incorporating specialized sensors and a series of interchangeable fixtures that allow for the accurate validation of multiple part numbers.
The equipment also integrates an intelligent servomotor that automatically adjusts the fixture positions according to the product’s length or variant, ensuring repeatability and eliminating manual adjustments.

The result is a more reliable, quantifiable, and fully traceable process that now provides accurate test values and ensures consistent validation in accordance with medical industry standards.

Initial Situation

The customer performed leak tests by manually submerging the product in water, injecting air, and visually searching for bubbles.
The method depended entirely on the operator’s judgment, which generated variable results and no quantitative measurements.
There was no accurate record of leakage values nor any way to guarantee uniformity between batches.
The variety of part numbers required constant and imprecise manual adjustments.

Challenge

Lack of precision in validation: visual inspection was not sufficient to guarantee quality in a medical device.
Lack of quantitative and traceable data for audits or process analysis.
High variability due to differences in technique and judgment between operators. Slow operations, with risk of errors and false positives or negatives.
Difficulty in accommodating different lengths and variations of the product without losing repeatability.

Solution

Implementation of an automated leak testing system with high-precision measuring equipment to obtain accurate and repeatable values.
Design of interchangeable fixtures adapted to the different customer part numbers.
Integration of an intelligent servomotor that automatically adjusts the position of the fixtures according to the length or variant of the product.
Complete automation of the testing cycle, eliminating subjective inspections and reducing human intervention.
Recording and traceability system to capture quantitative results in each test.

Results

Much more precise and quantitative results, completely replacing the visual method of leak detection.
Guaranteed repeatability, thanks to automated control of pressure, times and positioning.
Full traceability, ensuring that each piece is recorded with its corresponding measurement.
Reduction of human errors by eliminating the operator’s visual interpretation.
Greater efficiency in testing times, with a continuous and standardized flow.
Adaptability to multiple part numbers, thanks to the self-adjusting servo and custom-designed fixtures.

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