The Pioneer of Modern Leak Testing

Medical Device Production Line Layouts – The Good, the Bad and the Ugly

Uson’s medical device leak testing experts regularly visit medical device manufacturing plants around the world. One of the things we notice immediately is the wide diversity in production line layout and design.

USON Innovative Systems (UIS).Some of the production line designs are over-engineered and give rise to the related problem of excess in-process inventories. To help our customers avoid some of these pitfalls, Uson has developed a solution that combines our 50 years of leak testing knowledge with the capabilities of a long-time partner of 25 years. We call it USON Innovative Systems (UIS).

Instead of focusing on the “bad” and the “ugly” inefficient production lines, I would like to share some tips on what makes the “good” ones really good.

Continue reading

Gauge Capability Studies in Leak Testing Processes

Employing an automatic leak test station is one of the fundamental steps in advanced manufacturing system. This is done not only for assuring product quality, but also for monitoring process stability.

However, it is necessary to provide a practical way to evaluate the monitoring capability of an automatic leak test station for its application. The monitoring capability usually referred to as a Gauge Capability, or a GR&R (or simply R&R). A GR&R study should be done before incorporating the test station into a production process.

What is Gauge Repeatability and Reproducibility, or GR&R?

Continue reading

Medical Device Leak Testing Technology Innovations Continue

Ever since Uson first developed the leak testing technology for the US space agency NASA (National Aeronautics and Space Administration) in 1963, the medical device industry has been using the same dry air leak testing technology. As the European Sales Manager of the company, I regularly run into manufacturing engineers and other support staff throughout Europe who do not clearly understand the basic principles of leak testing for the medical device industry. As a result, they continue to run compromised assembly lines.

I recently saw a test station using a leak tester that was ideal for leak testing a single lumen catheter but was very inefficient when it came to testing multi-lumen catheters. What was really needed for this 4-lumen application was a 4-channel concurrent tester that is capable of switching between occlusion and leak testing on all four channels at once. Such a test process is much safer as each assembly is tested to the same pre-programmed rigorous test regime without the risk of a channel being missed, and you get the benefit of a much faster test.

Continue reading

Contact Us

Certifications


Uson L.P. - Corporate

8640 N. Eldridge Parkway
Houston, TX 77041 USA

Tel: +1-281-671-2000
Fax: +1-281-671-2001

Email: info@uson.com

Uson UK – Europe

Western Way
Bury St. Edmunds
Suffolk, IP33 3SP United Kingdom

Tel: +44-1284-760606
Fax: +44-1284-763049

Email: salesuk@uson.com

Uson – China

Room 601, 567 Lan Gao Road
Shanghai, 200333, China

Main: 021-583 65859, 021-583 59187
Fax: 021-583 59185, 021-337 73559

Email: sales@uson.com.cn