How can soft super-flexible medical products be leak tested accurately and quickly?

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It’s a given that manufacturers of medical devices and products are more than ever called upon to find new ways to help support homecare ; advanced wound care products that create negative pressure environments to accelerate healing are good examples.

These innovative specialty dressings deliver a vacuum at the wound site that helps draw wound edges together and in doing so removing infectious materials, reducing edema and promoting the type of tissue growth that closes the wound.

M1075 Leak Test Instrumentation

To function properly, these dressings need to conform to the wound bed and maintain negative (vacuum) pressures.
How to test these products is a big ask in a manufacturing environment given the production and quality requirements required.

High Speed Leak Testing

InterTech’s family of Med75 instruments are uniquely suited to meet the demanding requirements of the medical products industry.

Some key means to demanding Medical Device Industry requirements are provided and more by this Instrument and Fixturing that delivers:

• Proprietary leak test circuit designs incorporating patented mass flow solid state sensors at their core
• An automated R&R Mode facilitates machine qualification and audit traceability
• Instruments that are Ethernet IP capable and incorporate latest Industry Standards
• On-board data logging & analysis helps meet current risk management requirements
• Barcode scanner interface capabilities assures product traceability

And application knowledge….

InterTech is attending MDM West – leading medical design and manufacturing event

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InterTech is attending MDM West (Anaheim Convention Centre, Anaheim, CA) February 11-13, 2020 – the world’s leading medical design and manufacturing event.

Our booth is Booth 2386 – InterTech Development Company returns to the world’s largest medical technology show to share news of patented technologies available to speed medical device testing as never before, including:

• Patented sensor technology in MED75 test instruments
• LeanTest ®
• Unsurpassed accuracy
• Touch panel controls with real time test graphics
• Seamless handling of test data, storage of up to 40 million
test results
• Multiple configurations of leak and flow test
• EtherNet IP /  USB interface
• Gauge R & R mode
• And more patented technology for highest ROI test solutions

Register for this event at https://mdmwest.mddionline.com/ 

The Challenge of Leak Testing AV & EV Technology in the Automotive Industry

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The Challenge

As AV & EV technology rapidly advances, automotive design engineers are having to re-think automotive design. “Out of the box” thinking – literally and figuratively – is the order of the day if automotive vehicles – trucks, passenger vehicles, buses , taxis and more – no longer have to think first and foremost of enabling a human driver to see and navigate the road.

The challenge is more for manufacturing engineers – How can the components used for AV components & EV vehicle designs be brought to market quickly and inexpensively?

Test Process and Solution

Leak testing EV & AV components quickly and accurately is enabled by using InterTech M1075 leak test technology, long perfected for assuring integrity of sealed packages. These superior instruments have unsurpassed test accuracies with optimal GR&R.

InterTech M1075 Leak Testers have proprietary leak test circuit designs incorporating patented mass flow solid state sensors at their core.

These sensors are tuned for the demanding requirements of IP67 rated products.

• Instruments are Ethernet IP capable
• On-board data logging & analysis helps meet current risk management requirements
• Barcode scanner interface capabilities assures product traceability
• An automated R&R Mode facilitates machine qualification and audit traceability

M-1075 leak detectors optimize leak and functional testing processes

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The Challenge

Manufacturers want instrumentation designed to manage all their functional testing requirements. For high volume leak and functional testing they want instrumentation that simplifies integration with in-house networks. This includes integration to Manufacturing Execution Systems (MES) and Enterprise Resource Planning Systems (ERP). Instrumentation must transfer data bi-directionally, quickly change parameters and offer full traceability.

The InterTech Approach

Instrumentation on the InterTech M-1075 line of leak detectors is fully Ethernet IP compatible for control of test cycles and transmission of test results to a PLC or a central server.

Providing seamless communication between test devices, InterTech instrumentation enables adjustment of test parameters that might rely on a prior test. Additionally, corporate data networks can be linked for real time analysis of test results and corrective action of a process without production downtime.

Software enables the end user Lean Manufacturing, Process Performance Improvement, and Cost Improvement business transformation initiatives.

Oil and Air Testing Know-how by InterTech Dev Co.

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The Challenge

ISO 16949 quality assurance requirements, for a wide range of automotive parts such as solenoid valves, involve rigorous functional tests for engineering development, audit testing and production line testing. These automotive parts do not require just one test to assure proper function, but several. For example, many oil control valves usually include more than a dozen tests such as coil resistance, flow vs current, hysteresis, and leakage.

In some cases, hydraulic testing, usually with oil, is the best-match method to handle the wide range of functional test specifications that must be measured to acceptable Gauge R&R. In others, simpler air test methods are preferable.

Knowing which test mode to choose – air or hydraulic – requires a deep understanding of test methods, production line realities, and other application requirements.

The InterTech Solution – Some Test Process Features

Hydraulic Testing:

• Temperature controls for consistent viscosity.
• Audit testing to 150 DegC practical
• Circuit designs eliminate aeration problems.
• In-line filtration prevents test circuit contamination.

Air Testing:

• Parts remain clean and dry
• Fast and accurate testing
• Lower capital investment and tooling cost
• All results in a more competitive ROI

Unique Features

• InterTech M1075 Functional Test Instrument provides real-time test graph results of functional tests and test results with accept or reject status.
• Modular design simplifies removal, replacement or addition of standard stations for maximum flexibility
• Testing software enables remote monitoring of all assembly and test operations in real time over a factory intranet or the Internet, with advanced process control systems.
• Modular design simplifies removal, replacement or addition of standard stations for maximum flexibility.

 

Are Your Leak Tests Being Slowed by Long Stabilization Phases in Test Cycles?

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The InterTech Solution

InterTech’s patented mass flow sensor technology used in leak test systems combined with Ex-Heat® and FastFill® significantly reduces stabilization time and overall test cycle time for these large volume (4.5 Litre) parts to 22 seconds.

Depending on part configuration, stabilization times can be reduced up to 50%.

Showcasing leading Edge Leak Test Equipment

Superior Mass Flow Sensor Technology

Unlike generic test instruments, InterTech’s mass flow leak testers use patented sensors that are tuned to perform optimally and most sensitively within the test parameters required for testing these large volume windshield reservoirs.

InterTech’s Ex-Heat®

InterTech’s proprietary Ex-Heat® technology is used to reduce stabilization times during mass flow leak testing of these large volume parts. InterTech’s Ex-Heat® eliminates the need for cumbersome filler blocks and simplifies test system design.

InterTech FastFill®

Test times are further minimized by use of InterTech’s FastFill® test circuit designs. FastFill® is proprietary technology to introduce air quickly into the part being leak tested without creating harmful turbulence

Are your Medical Device Manufacturing Methods Liability-Proof?

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The Challenge

  • 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?

The InterTech Solution

Knowing what data to collect to document GMPs and the best test methods to use, to both gather this test data and use it to drive efficiency in test-intensive medical device and medical product manufacture, requires a sophisticated understanding of test methods and the latest patented technologies available for test-intensive leak and functional test methods.

An InterTech M1075 Leak Tester tests 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.

IP67 Protection Requirements for Autonomous and Electric Vehicle Components

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IP67 protection requirements for AV & EV components are mastered using InterTech’s long proven and technically superior leak test instrumentation. InterTech’s leak test instrumentation not only utilizes advanced mass flow sensor technology tuned for sealed package leak testing requirements, but also superior test circuit designs with optional patented add-ons such as Ex-Heat™ for large part testing or test-circuit built-ins for high-precision temperature compensation.

Users of InterTech test instrumentation also get the competitive advantages of streamlined leak testing with quickest response times, fast recovery from gross leaks (transducer saturation), testing that is independent of variations in supply pressure, and constant cycling from ambient pressure to test pressure, among other benefits.

Big Data Analytics and Leading Edge Leak Testing Instrumentation

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Many Manufacturing Industries including Automotive and Medical Device face a growing number of challenges and pressures. Cost pressure, competition, globalization, market shifts, and volatility are all increasing.

At the same time, big data and analytics today offer many possibilities for tackling these and many other challenges they face.

Efforts to streamline processes and optimize supply chains can be supported by examining every process component and supply chain link in detail. Big Data analytics give manufacturers this capability.

IDC offers know-how in seamless integration and innovation within the manufacturing environment in Leak Detection with its range of products, supplier management capability, and data transparency and reliability. 

IDC offers industry-leading quality management solutions that enables Big Data analysis and a path to better quality management.

 

 

 

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