Medical Device Leak Testing Automation and Validation

In respect to medical device leak testing automation and validation, global medical device manufacturers are seeking to eliminate the risk of releasing defective products to market that do not adhere to the device’s leak rate specifications. Uson provides complete leak testing system design though our USON-Innovative Systems (UIS) division.

UIS is a single source turnkey solution for semi-automated and fully automated leak testing applications.

Sophisticated automation systems such as state-of-the-art robotic part handling are tightly integrated with the Uson leak tester best suited for a particular leak testing application challenge by the industry leading engineering talent comprising the UIS service. All UIS production line designs are 21 CFR Part 11-compliant and built with IQ/OQ/PQ factory acceptance tests and FDA validation front-of-mind.

Medical Device Leak Testing Automation with UIS Turnkey Solutions

UIS marries a deep bench of mechanical and control engineering talent from Innovative Products and Equipment with Uson’s unsurpassed leak testing applications engineering team. Our customers seeking to automate or semi-automate their NDT leak testing operations can get a turnkey single source custom clean assembly design that is not only tuned to their leak testing needs but is also the most efficient production line design possible.

This system features six Optima^vT testers performing 48 simultaneous leak tests.

Medical device leak testing automation means lower costs, faster throughputs, simple regulatory validation and compliance and faster time-to-market—the top-level concerns of all medical device manufacturers worldwide.

Tried-&-True Leak Testing Automation Solutions for Medical Device Manufacturers.

Leak testing systems are an extension of Uson’s product line that incorporate best-in-class equipment combined with well thought out, solidly designed, engineering solutions. There is very little in terms of leak testing production lines that we haven’t encountered before. We bring a number of state-of-the-art automated assembly designs to give medical device manufacturers a tried-and-true solution and when they have unique needs, we have the team in place to create new solutions in rapid order. We understand what FDA compliance requires and we make it very straightforward for medical device manufacturers to validate their processes accordingly.

UIS Leak Test Systems at A Glance:

Test:

• Pressure decay
• Differential pressure
• Vacuum
• Functional

Fixtures:

• Manual, pneumatic, hydraulic

Guards:

• Unguarded (<2 bar / 30psi)
• Manual, semi auto, 2 hand start
• HMI as specified by client.
• Light guard

Control:

• PLC or relay

Marking:

• Ink marking, percussion, laser.

Clamping & Sealing:

• Automatic or manual

Sealing method:

• Flat pads or auto couplings.

Let’s Talk About Your Next Project!

In most cases, UIS will provide a detailed application quote within two weeks of request. We make full use of video conferencing to facilitate client meetings for concept and design review, progress meetings, and even factory acceptance testing. Contact us today and let's talk about your next project.