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

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Manufacturers of medical devices and products are being called upon to find new  ways to help support homecare—proven to have better clinical  outcomes for many treatments and almost always preferred by patients. Today’s 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—simultaneously removing infectious materials, reducing edema and promoting the type of tissue growth that closes the wound.  

To function properly, these dressings need to conform to the wound bed and maintain negative (vacuum) pressures.  They must be soft and flexible to allow for easy application, yet at the same time maintain tight seals to preserve aseptic conditions.

This is one of those situations where the adage “easier said then done” comes into play—until now……IDC technology know how

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Can We Speed Up Large Volume Part Leak Testing by Eliminating Filler Blocks?

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Oil pans require leak testing—a production step historically slowed by the relative large volume of each part.   Traditionally, filler blocks are incorporated into the test process in order to reduce the test volume making the leak test cycle both more accurate and relatively faster.  Loading and unloading filler blocks do add time to the production process.  But without filler blocks, the stabilization phase of testing proceeds too slowly and with too much error.

The InterTech Solution:

  • InterTech Development Company engineers a leak test system where oil pans are tested to a 10 sccm limit, at a pressure of 100kPa (14.5psig) within 19 seconds.
  • This fast production rate is achieved without filler blocks. InterTech’s fast oil pan leak test system includes:
  • Superior test accuracy and at faster speeds using the InterTech M1075 Mass Flow Leak Detector to control the test cycle 
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 oil pans.
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When a 5 Micron hole is a HUGE problem – a White Paper from IDC

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This white paper, “Mass Flow Leak Testing Technology Update”, is geared for engineering teams that are seeking proven methods to cut production costs without compromising product quality.  After reviewing the pros and cons of prior leak testing methodologies, we will drill into some detail re: the benefits of latest generation mass flow sensor systems that can be tuned to the specific pressure, temperature, part geometry and other application specifications. 

 Such systems can provide best gauge R&R leak testing in ranges as low as 0.01 sccm even for with parts with high internal volume high volume, and in the widest possible range of production line pressure or vacuum test scenarios.

 Key areas covered in White Paper include:

  • Historic Leak Testing Methods
  • Accuracy Considerations
  • Test Cycle Times
  • Summary – Updated Mass Flow Sensors and Application Matching
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On Going Design Reports Updates from IDC on Key Technologies- 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 manufacture? 

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 such that sterilization steps are not undone? 

These questions and more must be answered and documented with a very high degree of certitude, not only to establish GMPs for regulators but also to ensure that your manufacturing operation is protected in the litigious medical industry.  

And, for manufacturers of relatively low margin medical products such as check valves or plastic medical bags, the same attentions to production rates and bottom lines typical in other test-intensive manufacturing lines such as those making automotive products can’t be ignored.  

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Leak Testing medical tubing for both small leaks and unimpeded flow

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Is it possible to test medical tubing for both small leaks and unimpeded flow at a rate of 3.75 seconds per part while also meeting ISO 13485 requirements?

 The Challenge:

 A family of plastic medical tube sets require both leak and flow testing at 62kPa (9 psig) to determine that they function as designed—without significant leaks (detecting leaks as small as 0.1 sccm) and with unimpeded flow rates (user selected 0.4 – 20.0 sccm).  Four different tube configurations are to be tested.

While quality cannot in any way be compromised, competitive pressures for these relatively low-cost medical products is such that a relatively fast production rate of 16 fully tested parts per minute (3.75 seconds/part) must be achieved.

The InterTech Solution:

EtherNet/IP enabled InterTech Med75 dual function leak and flow test instruments fully test 16 parts per minute with GR&R of less than 20% in accordance with ISO 13485 Requirements for Maintaining Consistent Quality Systems.

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Updates on Testing Options- – Tackling Costs!! LeanPass

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Some other Updates on Testing Options- – Tackling Costs!!

Isn’t Pressure Decay Leak Testing Always the Lowest-Cost Method???

Answer: No! Pressure Decay Test Methods Can Raise Costs Up to 50%!

Many make the mistake of equating the upfront costs of a leak tester instrument with the costs of the leak testing in total. Over the economic life of a leak tester, the upfront costs of the test instrument are a mere fraction, often trivial, of the overall testing costs.

 Pressure-decay leak testing is difficult because measurements are highly vulnerable to changes in testing conditions such as drafts or temperature and there are often difficulties in determining the volume of test parts and test circuits, which must be known in order to calculate results. Also, pressure decay methods, including differential pressure decay methods, have hidden costs that derive from the need to make two measurements and then correlate results to determine a leak rate. Two measurements mean double the chances for measurement error. In addition, the longer the interval between the two measurements the higher the probability for measurement error – especially for leak testing large volume parts.

The problems inherent in pressure decay can be avoided by using an InterTech M1075 with LeanPass™ to achieve a cycle time reduction of up to 50%.

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US Patent – New Technology Insights

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USPatent#10,107,711

 

United States Patent

  • IDC has been awarded a new Technology Patent based on new technology insights by key company experts in understanding thermal effects during leak detection.
  • IDC has utilised the technology in a number of applications and is utilising it in the evaluation of sample parts for new / current clients.
  • There are many key varied areas this technology can be utilised in a range of applications e.g. Intake Manifolds, Rocker Covers and Oil Pans to state a few….more to follow……
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Assembly Show Chicago October 2018

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  • The recent ASSEMBLY Show Oct 2018 provided an Assembly and Testing driven content as suppliers’ buyers and users explored new Assembly / Test techniques, products and services and in doing so helping suppliers, buyers and users of assembly equipment in manufacturing plants connect, learn share and explore all things Assembly and Testing including leading edge technology regarding Leak Detection methodologies.
  • The IDC Crew manning the booth received many interesting visits with Prospects as well as existing Customers turning up with Sample Parts / Applications and engaging in informative dialogue on their Leak Testing requirements and possible solutions utilizing IDC test technology and know-how.
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