- Have the hermetic seals, required for your medical product to remain aseptic been compromised during the manufacturing process?
- Have manufacturing steps such as welding unwittingly introduced blockages that prevent a device from functioning as designed?
- Are your products sufficiently leak-proof such that contaminants are kept out permanently and that sterilization steps are not undone?
Medical Leak Testing Solution
Knowing what data to collect for documentation of GMPs (good manufacturing practices) and the best test methods to gather, test, and use data it to drive efficiency for test-intensive medical device and medical product manufacture is crucial. This requires a sophisticated understanding of test methods and the latest patented technologies available for test-intensive leak and functional test methods.
Intertech offers a solution for leak testing for medical devices utilizing InterTech M1075 Leak Tester which ensures accurate leak testing for plastic medical bags of various sizes at a pressure of 35 kPa (5 psig) to detect 0.5 sccm leaks that are equivalent to leaks from a 5 micron hole.
A GR&R of less than 10%, is achieved, meeting ISO 13485 requirements.
For more information about leak testing for medical devices and how to drive efficiency in medical product manufacturing, contact us today!