Automatic leak detection is now a common occurrence and part of the quality control process for many companies. There is a wide choice of equipment available and techniques from which to choose.
USON leak testing equipment is used around the world by manufacturers of all kinds of medical devices, medical equipment and medical supplies that have specifications for leak rates – catheters, drug-eluting stents, laparoscopic surgical instruments, medical check valves, ocular surgical kits, wound care supplies, sealed device packaging and more.
Leak testing of medical devices and medical device components
When quality and patient safety require reliable leak testing of medical device components, sub-assemblies and/or fully assembled medical devices, equipment and technology, leading medical device manufacturers look to USON and its deep bench of leak testing applications engineering expertise.
USON leak testing equipment has cradle-to-grave support, from validation to re-configuration for testing new device designs. Always ‘on-call’, USON has designed more medical device leak test solutions than any other company in the world.
A detailed no-cost evaluation of best-match leak testing equipment for your medical device requirements will typically be returned to you within 48 hours by USON’s leak testing applications engineers. Similarly, a detailed proposal for semi- or fully-automated leak test assemblies will typically be returned to you within two weeks, or sooner. At your request, and also at no charge, video conference consultations are also available to discuss your leak test challenges.
Leak and flow tester for medical devices
The unique Optima vT multi-sensor design can leak test two parts with four chambers needing different leak test or other test specifications or simultaneously test one medical device with eight compartments that need to function differently. If you want to do sequential multiple leak or other tests on each part with a throughput of more than a million parts per year this is the world’s best-match leak detector.
Optima vT was designed to not only handle leak and flow testing of the medical device designs you have today; it can be easily re-configured for medical device designs of the future.
Features that make Optima vT so versatile include: a highly intuitive and large easy-to-read operating display built both for operators and engineers programming leak test and other test sequences; ability to do any combination of flow tests, pressure decay leak tests, differential pressure decay, vacuum leak tests, occlusion or burst and cracking pressure tests, force decay leak tests and more (combining for over a half billion possible permutations on test sequences); totally customizable pneumatic configurations; built-in automated calculators; and multiple options for data handing and data storage.
Leak detector for small-volume medical device production
Sprint IQ is the leak detector used and validated for FDA compliance by the greatest number of medical device manufacturers in the world. Sprint IQ is the ideal leak tester for small-volume medical device component leak testing at the fastest throughputs. It has up to 13 different leak test modes – pressure decay, mass flow, vacuum, occlusion / burst, etc. – with the capability to run up to four tests concurrently.
Leak tester for high-volume medical device production lines
The Vector leak tester has up to ten independent leak test channels (up to two sensors, i.e. 20 independent leak tests) making it the best-in-class leak detector for high-volume medical device production lines. Any medical device that requires multiple types tests performed asynchronously – up to 20 leak and flow test types in any combination – can harness Vector, the world’s leak testing equipment ‘powerhouse’. Windows®-based, extensive I/O programming, easy integration into automated assemblies and more – Vector is designed for leak testing any size part, or for medical devices in high volumes.
Leak testing equipment for medium-volume leak testing
Qualitek MR leak testing equipment features USON’s proprietary and most sensitive differential pressure decay sensor and a wide array of other leak tests to select from, up to 32 I/O step programming, easy integration into automated assemblies, ready-to-use pneumatics and electronics. This is the best match leak detector for medium volume (up to 4l) single channel leak testing.
Non-destructive leak testing
Flexible packaging of medical devices can be non-destructively tested under vacuum for leaks with real-time monitoring during production with Qualipak, unique leak testing equipment that totally eliminates human error or requirements for highly trained operators needed for other types of package leak testers.
Semi-automated and fully automated medical device leak testing
USON Innovative Systems (UIS) provides world-class turnkey solutions for semi-automated and fully automated medical device leak testing.
UIS delivers accelerated time-to-market with a validation-centered approach, industry-leading engineering talent with a concentration on solving leak testing challenges, efficient automated systems with high reliability USON leak testers, and elimination of risks inherent with less sophisticated systems or lower quality leak testing equipment.
Most pressure decay panels measure pressure changes in mbar, Pascal, mbar/sec or Pascal/sec. This presents a challenge because leak specifications are usually specified in volumetric units such as cc/sec or cc/min.
Employing an automatic leak test station is one of the fundamental steps in advanced manufacturing system not only for assuring product quality, but also monitoring process stability.
The laws of physics that determine the best match leak test methods have not changed. What has changed is the technology available that makes one or another leak tester the best match technology.
Eight Great Things Manufacturing Engineers Must Know About Leak Testing Equipment to Maintain Quality Control Without Sacrificing Production Speeds
Must quality engineers and production managers always be at odds? The former seeks perfection while the latter pushes for greater throughput.
Uson, global leader in leak testers and systems, is celebrating 50 years of innovative thinking and leadership by proclaiming the dawn of "The Usonian Age."
USON has released a selection of free white papers on Medical Device Network, providing advice on leak testing methods, product choices and considerations.
Uson's Optima vT Leak and Flow Tester provides manufacturing, design and quality engineers, automation specialists and machine builders an affordable leak tester that is fully customizable to their specific leak testing applications and requirements.
How can you test for leaks if the component is completely sealed, and has no ports or openings?
Global medical device manufacturers seeking the highest standards of lean manufacturing for leak-proof medical devices by using RFID tags for parts identification and information tracking can now use a unique electronic label system built by Uson with both standard and custom components tailored to application requirements. The custom elements of Uson RFID tags streamline parts processing and help manage test data while cutting overall production cost.
Global medical device manufacturers seeking to eliminate the risk of releasing defective products to market that do not adhere to the device's leak rate specifications can now rely on Uson-Innovative Systems (UIS), a newly created joint venture between Uson's best-in-class leak testers and Innovative Products and Equipment's automation systems expertise.
Medical device design and manufacturing engineers seeking leak detection equipment that can be custom configured to their unique test application requirements without added costs can now obtain a competitively priced and first-of-a-kind leak and flow tester from Uson.
Medical device manufacturers seeking increased production efficiencies and lower costs, now possible with use of state-of-the-art leak detectors for leak-sensitive medical device assembly, can select between two new leak detection equipment matching services from Uson.
Manufacturers of medical devices requiring leak testing, who are seeking continuous quality improvements and/or faster leak test cycle times while maintaining Gage R and R, can now schedule customised videoconference demonstrations of the of mathematical functions built into USON's recently-unveiled Optima vT leak and flow tester. These one-on-one no-cost video consultations will include application-specific demonstration of how Optima's built-in mathematical tools could improve yields and quality.
Medical device manufacturers that use leak test instrumentation on production lines for inspecting components and products for leaks and/or flow rates and similar leak detection applications can now achieve both higher quality and efficiency operations through improved training offered at no charge by Uson.
Uson, pioneer of automated leak detection equipment for the automotive, industrial, medical device and packaging industries, announces the appointment of an award-winning veteran of the automated instrumentation industry, Charles D Foran Jr (Dave), as USON President.
Medical device and biotechnology product manufacturers can now obtain the USON Pressure Decay Leak Test Calculator-- the first in a family of automated Uson NDT test calculators - to generate nearly instantaneous answers to 'What If' modeling of pressure decay leak testing variables and exact returns-on-investment from new eight-sensor concurrent leak testing technology
Dave Foran, president of Uson, is pleased to announce the appointment of Gene Grilli to be Uson global sales director.
Medical device design, manufacturing and quality engineers seeking best match leak test solutions can now rely on Uson's no-cost videoconferencing consultations to facilitate discussions and visual inspection of leak-proof medical device components and products for which the appropriate leak detection equipment, fixturing and all other leak test specifications are required.
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