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Machine Solutions Inc. acquires Crescent Design Inc.

Crescent Design’s Hydraulic Burst Leak Tester joins a collection of best-in-class testing and manufacturing equipment for medical device manufacturers

FLAGSTAFF, Ariz. – Aug. 25, 2020 – Machine Solutions Inc. has announced that it has acquired the assets and business of Crescent Design Inc. The acquisition brings together two advanced technology providers to the medical device industry. Crescent Design, headquartered in San Diego, designs and manufactures proprietary hydraulic burst leak test equipment, associated accessories and other auxiliary equipment used in the manufacturing of medical devices.

Machine Solutions and its industry-leading brands—MSI, Steeger USA, Vante, PlasticWeld Systems and SEBRA—continue to increase the range of products and services provided for medical device manufacturers. The acquisition of Crescent Design and its Hydraulic Burst Leak Tester adds another ISO 10555 test requirement to the list of catheter testing capabilities within Machine Solutions’ product catalog, and brings a global sales and service team to support and further develop the Crescent Design technology. The acquisition directly aligns with Machine Solutions’ long-term strategy to provide its customers with a single source for diverse equipment and services to meet their development, production and testing validation needs.

Image may be NSFW.
Clik here to view.

Founder Steven Royce and Value Stream Leader Christina King share their thoughts on what the acquisition means to Crescent customers. Click Image to WATCH VIDEO

“Crescent Design’s Hydraulic Burst Leak Tester is the standard for testing in the catheter manufacturing industry,” said Machine Solutions President Brian Strini. “We are excited to add another best-in-class technology to our testing equipment catalog and look forward to the additional capabilities we can bring to our customers.”

“Over the years, I recognized the parallel paths that Machine Solutions and Crescent Design have shared—both are committed to quality, innovation and customer service, and I felt that we would work well together,” said Crescent Design Vice President and Co-Founder Steven Royce. “This partnership will provide additional resources to allow continued technical product improvements and in-person customer support in more locations around the world.”

Crescent Design President and Co-Founder Jay Sarno added: “This partnership provides us with the engineering resources needed to develop the next generation of market-leading burst leak testing equipment that will have improved accuracy, be easier to use and be compatible with emerging 21-CFR part 11 compliant test systems.”

Crescent Design is Machine Solutions’ fifth acquisition since joining the BW Forsyth Partners family of companies in 2012.

 

 ABOUT MACHINE SOLUTIONS INC.

Machine Solutions Inc. is the premier provider of advanced equipment and services to the medical device industry. The unified brands of MSI, Steeger USA, Vante, PlasticWeld Systems and SEBRA provide a breadth of products to support customer needs and growth. Machine Solutions provides superior customer experiences by focusing on delivering quality and value, and by dedicating resources to its aftermarket team for technical service and process support. Machine Solutions has been instrumental in automating manual processes in catheter and stent manufacturing operations and the broader medical device industry. Machine Solutions is privately owned by BW Forsyth Partners, a Barry-Wehmiller company. For more, go to machinesolutions.com.

 

ABOUT BW FORSYTH PARTNERS

BW Forsyth Partners is the investment arm of multibillion-dollar global manufacturing and engineering consulting firm Barry-Wehmiller. Established in 2009, BW Forsyth Partners blends Barry-Wehmiller’s unparalleled legacy of value creation and people-centric culture development with keen investing experience to help companies realize their true potential. With a focus limited to areas known well, BW Forsyth Partners seeks to partner with leadership teams to acquire small- to middle-market companies in the capital and component equipment, and professional services sectors. In each of our operating companies, BW Forsyth Partners deploys operational improvements and strategy development without compromising the autonomy, strategic vision and entrepreneurial spirit of their leadership teams. For more information, visit bwforsyth.com.

The post Machine Solutions Inc. acquires Crescent Design Inc. appeared first on Crescent Design.


HBLT can be used for ISO 594-1 and 2 compliant testing

In the past few years, there have been several inquiries regarding the HBLT’s ability to perform tests that comply with different ISO standards. Crescent Design’s HBLT can perform tests that are ISO 594 compliant. The HBLT can be programmed to perform the test method described in ISO 594-1 and 2, section 5.2 (test method for liquid leakage from fitting assembly under pressure). The HBLT can detect a “leakage sufficient to form a falling drop” as required by ISO 594.

The video shows the HBLT being used in conjunction with Pressure Manager Software so that the ISO 594 compliant test can be visualized.

The post HBLT can be used for ISO 594-1 and 2 compliant testing appeared first on Crescent Design.

HBLT Care & Feeding – Top 10 Tips

Follow these Top 10 tips to ensure optimal performance of your HBLT.

  • Warm up HBLT for 24 hours prior to calibration
  • Always leave your HBLT turned on
  • Purge the HBLT every day using a syringe or the Vacuum Purger
  • Make sure the fluid supply is on the same surface as the HBLT
  • Insure the water reservoir is vented
  • Keep the water reservoir clean
  • Only use fingers to operate the touch screen
  • Document passcode information
  • Fasten all serial port cable connections with the shell screws
  • Do not use, store or ship the HBLT in freezing temperatures

HBLT User Quick Tips PDF

The post HBLT Care & Feeding – Top 10 Tips appeared first on Crescent Design.

Which is best to Connect Parts for Pressure Testing?

When attaching a part under test to the Hydraulic Burst/Leak Tester (HBLT), the ideal method is a direct connection to the HBLT outlet port. However, when parts are in a safety enclosure or water bath, you must extend the hydraulic path from the HBLT outlet to the part. This usually means adding an extension tube to your fixture.

The main goal is to select tubing that does not affect the test results. The tubing must have sufficient inner diameter to allow some flow without a pressure drop. The tubing should have no or minimal compliance. In addition, any tubing must be easily purged if it is left in place for extended periods. Finally, keep the tubing length as short as possible. Overall tubing compliance worsens with length.
When using the HBLT with a Smart Manifold in parallel mode, take special precautions to insure the sum of the compliance of all ten extension tubes does not affect your test. Use the least compliant tubing and keep the lengths as short as possible.

The ideal tubing is stainless steel tubing with compression fittings. If the flow demands are low, then smaller diameter tubing is easily bent into shapes and attached at both ends with compression fittings. Crescent Design sells an Outlet Plumbing Kit which provides the HBLT user with a quick and easy means for attaching product to the HBLT for testing. For higher flow rates, larger diameter tubing formed with multiple pieces or bent with tubing bending tools works well.

Image may be NSFW.
Clik here to view.

Plastic tubing that is sufficiently non-compliant also works as well. We have found that Qosina part number 33018 is a good substitute to stainless steel for some applications. It is made of two coextruded plastics that have little compliance but are flexible. This tubing works well with water baths where the parts are attached and then moved into the water bath for testing. The flexibility of the plastic is superior to the fixed shape stainless steel tubing in this application.

Avoid using braided steel high-pressure tubing. This tubing is extremely compliant until the inner rubber or plastic tube contacts the steel braid. This can affect the ramp rates because of the overall changing compliance characteristics.

If you need to evaluate your tubing selection, request the document Tubing Extension Sets Compliance Study from Crescent Design. This document details testing methods to insure a good tubing selection.

The post Which is best to Connect Parts for Pressure Testing? appeared first on Crescent Design.

Burst Testing an Angioplasty Balloon with the Hydraulic Burst Leak Tester

This video demonstrates the Crescent Design Hydraulic Burst Leak Tester and Crescent Design’s Pressure Manager© software being used to burst-test a raw angioplasty balloon.

We see the balloon being filled prior to the actual start of the linear ramp test. When the actual test begins you see that it acquires the ramp rate quickly and maintains 20 psi per second until the balloon bursts.

You can also see that the volume (the lower blue trace) is reported as the balloon expands and stretches. The delivery rate remains fairly constant until the pressure reaches about 50 psi when the balloon begins to expand faster and the volume delivery rate increases. The Hydraulic Burst Leak Tester’s sophisticated control software is automatically increasing the volume delivery to maintain the desired pressure ramp rate.

The Pressure Manager© summary screen displays the pressure and volume values in real time until balloon bursts where it captures the actual burst event pressure of 336.5 psi and the event volume of 1.09cc. The Result Messages shows the test elapsed time of 16.9 seconds.

The post Burst Testing an Angioplasty Balloon with the Hydraulic Burst Leak Tester appeared first on Crescent Design.

HBLT Troubleshooting Guide

Overview:
This document will cover basic issues that may arise with the HBLT and provide a guide on how to troubleshoot and resolve them. HBLT Troubleshooting Guide PDF

Problem Possible Problem Possible Solution

BURPING

The HBLT is experiencing excessive burping (clicking) when trying to run a test.

The 0 pressure point of the HBLT has drifted. If the HBLT is burping (clicking) excessively it is most likely sitting over +/-2PSI when open to atmosphere. Note: Some burping is common and expected especially if you have a high purge rate set on the HBLT. On average 2 to 4 clicks is fine.

Since the HBLT has drifted off its zero point you will need to calibrate the HBLT. Please review the Owners Manual and see our website at www.Crescentdesign.com and go to the “How To” videos section for a demo video on calibrating the HBLT.

PRESSURE OVERSHOOT

HBLT overshooting the programmed pressure target.

This can be caused by one or more of these issues:

  • Air in the system (most common)
  • Incorrect compliance setting
  • Up Ramp Rate setting too high

Make sure to purge the HBLT under vacuum every morning or before the start of each shift. Run a total of 3 purge cycles under vacuum. Note: Always make sure that your parts are prepped and purged of air for best test results.

Lower the compliance setting

Lower the Ramp Rate

MOTOR STALLED ERROR

When purging the HBLT under vacuum and the “Motor Stalled” error message is displayed.

If the HBLT purges into an open container with nothing attached to the outlet, but the motor stalls when purging under vacuum the HBLT needs to be calibrated.

If this error is displayed while running a test please contact Crescent Design.

Calibrate the HBLT. Please review the Owners Manual and go to www.Crescentdesign.com and navigate to “How To” videos section for a demo video on calibrating the HBLT.

MOTOR OVERHEATING ERROR

When running a test and the “Motor Overheating” error is displayed.

It is possible to get the actuator motor hot during tests that maintain high pressures for long periods of time or during fatigue tests with a large number of cycles. The motor needs to be turned off to cool down.

It is possible to get the actuator motor hot during tests that maintain high pressures for long periods of time or during fatigue tests with a large number of cycles. The motor needs to be turned off to cool down.

Turn off the HBLT. Use a rag or towel to put over the luer connection at the outlet and disconnect it to relieve the pressure. Let the HBLT sit while turned off for 30 minutes to let the motor cool.

PRESSURE LIMIT EXCEEDED ERROR

When running a test and the “Pressure Limit Exceeded” message is displayed.

The hydraulic pressure exceeded the operational limits of the HBLT. The main cause of this problem is mis-calibration.

Target pressure is close to the HBLT limit.

Calibrate the HBLT and run the test again. If the issue persists please contact Crescent Design.

Lower the ramp rate.

THE CYLINDER IS OUT OF WATER CHECK FOR LEAKS

When running a test the “Cylinder is out of water check for leaks” is displayed.

This message is displayed when the actuator reaches the exhaust limit switch while running a test. This can occur if the product leaks, is very compliant, or is compliant and large. The cylinder does not have enough volume to reach the target pressure and maintain it.

Internal HBLT leakage.

If not using a FILL: Check the product for leaks.

Pre-fill the product before running the test.

Try constraining the product to limit its compliance.

Lean HBLT on side and see if any water comes out of enclosure.

A FILL (or PURGE) TIMEOUT HAS OCCURED. PLEASE CALL FOR SERVICE.

During the fill sequence the “Fill Timeout” message is displayed.

The HBLT displays this alert message when the fill operation times out without encountering a limit switch. The timeout value varies depending on the cylinder volume.

Wrong power module inlet power selection.

Install power module voltage selector for 110-120V

FALSE BURST REPORTED

When running a test and the HBLT declares a burst but the product is intact with no failure or leak.

Tubing loose in Tuohy-Borst which allows the tubing to slip in the fitting causing a sudden drop in pressure.

CAUTION: Over tightening the Touhy-Borst fitting can collapse the tubing restricting fluid flow and pressurization of the product under test.

An internal HBLT leak.

Change the compression fitting rubber O-ring often. A damaged O-ring will cause connection issues. Use a quality connector such as the Plasti-Mate Tuohy-Borst made by S4J manufacturing PN# A7530. Mark the balloon stem with a black sharpie right at the connection so you can see if it slips.

It may be necessary to use a hypo tube inside the I.D. of the product tube to allow sufficient compression of the fitting without collapsing the fluid path. This will also ensure repeatable product-to-product test results.

To check the HBLT for leaks, install a metal cap or ball valve directly to the outlet and run a simple ramp test to the maximum pressure of the HBLT and let it dwell for 60 seconds. If it leaks down more than 10% in 60 seconds please contact Crescent Design.

FALSE BURST AT START OF DOWN RAMP

The up burst or down burst setting is too close to the down ramp rate setting.

Increase the down burst rate or decrease the down ramp rate.

Ensure that the compliance settings are correct (not too high).

FALSE BURST AT THE BEGINNING OF A TEST

The initial (starting) pressure is negative (below zero) causing the HBLT to detect a downward pressure decay.

Check HBLT calibration and adjust if necessary. Ensure that zero is adjusted close to zero.

INTAKE LIMIT ERROR

If this error is displayed when running a test it may be caused by the HBLT zero calibration point not being at zero (or close to zero). If zero is off more than 3 PSI the intake limit switch could be reached before reaching zero PSI.

Calibrate the HBLT. Review the Owners Manual and go to www.Crescentdesign.com and navigate to “How To” videos section for a demo video on calibrating the HBLT.

EXHAUST LIMIT ERROR

If this error is displayed it could be one of the following issues:

An HBLT or product leak prevents reaching the target pressure. This allows the HBLT to activate the exhaust limit switch.

The product is too compliant or large for the HBLT to reach the set pressure.

To check the HBLT for leaks, install a metal cap or ball valve directly to the outlet and run a simple ramp test to the maximum pressure of the HBLT and let it dwell for 60 seconds. If it leaks down more than 10% in 60 seconds please contact Crescent Design. Inspect the product for pinhole leaks.

Check maximum volume output of your model HBLT and verify how much volume is needed to test each different product.

The post HBLT Troubleshooting Guide appeared first on Crescent Design.

How does Pressure Manager© work with micrometers?

Pressure Manager© is software that coordinates the HBLT (Hydraulic Burst Leak Tester) pressure profiles and micrometer readings. The common method is to command the HBLT to perform a staircase test using either a test or a sequence of commands called a script. At each step in the test, Pressure Manager© requests a micrometer reading after maintaining the pressure. If using a script, Pressure Manager© records pressures and diameter each for each execution of the READ MICROMETER command. During the test or script, Pressure Manager© keeps a table consisting of the desired pressure, the actual pressure and the micrometer reading. Optionally, Pressure Manager© saves the table data in a comma-delimited file for documentation or further analysis.

Pressure Manager© uses two types of micrometers. The first is the Mitutoyo contact micrometer using the PC serial interface. The second is the Keyence optical micrometer using the PC serial interface to the Keyence 7601 micrometer controller. There are several micrometer heads available for measuring different ranges.

Learn more about the Pressure Manager© Software and learn more about the HBLT.

The post How does Pressure Manager© work with micrometers? appeared first on Crescent Design.

Machine Solutions Inc. acquires Crescent Design Inc.

Crescent Design’s Hydraulic Burst Leak Tester joins a collection of best-in-class testing and manufacturing equipment for medical device manufacturers

FLAGSTAFF, Ariz. – Aug. 25, 2020 – Machine Solutions Inc. has announced that it has acquired the assets and business of Crescent Design Inc. The acquisition brings together two advanced technology providers to the medical device industry. Crescent Design, headquartered in San Diego, designs and manufactures proprietary hydraulic burst leak test equipment, associated accessories and other auxiliary equipment used in the manufacturing of medical devices.

Machine Solutions and its industry-leading brands—MSI, Steeger USA, Vante, PlasticWeld Systems and SEBRA—continue to increase the range of products and services provided for medical device manufacturers. The acquisition of Crescent Design and its Hydraulic Burst Leak Tester adds another ISO 10555 test requirement to the list of catheter testing capabilities within Machine Solutions’ product catalog, and brings a global sales and service team to support and further develop the Crescent Design technology. The acquisition directly aligns with Machine Solutions’ long-term strategy to provide its customers with a single source for diverse equipment and services to meet their development, production and testing validation needs.

Image may be NSFW.
Clik here to view.

Founder Steven Royce and Value Stream Leader Christina King share their thoughts on what the acquisition means to Crescent customers. Click Image to WATCH VIDEO

“Crescent Design’s Hydraulic Burst Leak Tester is the standard for testing in the catheter manufacturing industry,” said Machine Solutions President Brian Strini. “We are excited to add another best-in-class technology to our testing equipment catalog and look forward to the additional capabilities we can bring to our customers.”

“Over the years, I recognized the parallel paths that Machine Solutions and Crescent Design have shared—both are committed to quality, innovation and customer service, and I felt that we would work well together,” said Crescent Design Vice President and Co-Founder Steven Royce. “This partnership will provide additional resources to allow continued technical product improvements and in-person customer support in more locations around the world.”

Crescent Design President and Co-Founder Jay Sarno added: “This partnership provides us with the engineering resources needed to develop the next generation of market-leading burst leak testing equipment that will have improved accuracy, be easier to use and be compatible with emerging 21-CFR part 11 compliant test systems.”

Crescent Design is Machine Solutions’ fifth acquisition since joining the BW Forsyth Partners family of companies in 2012.

 

 ABOUT MACHINE SOLUTIONS INC.

Machine Solutions Inc. is the premier provider of advanced equipment and services to the medical device industry. The unified brands of MSI, Steeger USA, Vante, PlasticWeld Systems and SEBRA provide a breadth of products to support customer needs and growth. Machine Solutions provides superior customer experiences by focusing on delivering quality and value, and by dedicating resources to its aftermarket team for technical service and process support. Machine Solutions has been instrumental in automating manual processes in catheter and stent manufacturing operations and the broader medical device industry. Machine Solutions is privately owned by BW Forsyth Partners, a Barry-Wehmiller company. For more, go to machinesolutions.com.

 

ABOUT BW FORSYTH PARTNERS

BW Forsyth Partners is the investment arm of multibillion-dollar global manufacturing and engineering consulting firm Barry-Wehmiller. Established in 2009, BW Forsyth Partners blends Barry-Wehmiller’s unparalleled legacy of value creation and people-centric culture development with keen investing experience to help companies realize their true potential. With a focus limited to areas known well, BW Forsyth Partners seeks to partner with leadership teams to acquire small- to middle-market companies in the capital and component equipment, and professional services sectors. In each of our operating companies, BW Forsyth Partners deploys operational improvements and strategy development without compromising the autonomy, strategic vision and entrepreneurial spirit of their leadership teams. For more information, visit bwforsyth.com.

The post Machine Solutions Inc. acquires Crescent Design Inc. appeared first on Crescent Design.


HBLT can be used for ISO 594-1 and 2 compliant testing

In the past few years, there have been several inquiries regarding the HBLT’s ability to perform tests that comply with different ISO standards. Crescent Design’s HBLT can perform tests that are ISO 594 compliant. The HBLT can be programmed to perform the test method described in ISO 594-1 and 2, section 5.2 (test method for liquid leakage from fitting assembly under pressure). The HBLT can detect a “leakage sufficient to form a falling drop” as required by ISO 594.

The video shows the HBLT being used in conjunction with Pressure Manager Software so that the ISO 594 compliant test can be visualized.

The post HBLT can be used for ISO 594-1 and 2 compliant testing first appeared on Crescent Design.

The post HBLT can be used for ISO 594-1 and 2 compliant testing appeared first on Crescent Design.

HBLT Care & Feeding – Top 10 Tips

Follow these Top 10 tips to ensure optimal performance of your HBLT.

  • Warm up HBLT for 24 hours prior to calibration
  • Always leave your HBLT turned on
  • Purge the HBLT every day using a syringe or the Vacuum Purger
  • Make sure the fluid supply is on the same surface as the HBLT
  • Insure the water reservoir is vented
  • Keep the water reservoir clean
  • Only use fingers to operate the touch screen
  • Document passcode information
  • Fasten all serial port cable connections with the shell screws
  • Do not use, store or ship the HBLT in freezing temperatures

HBLT User Quick Tips PDF

The post HBLT Care & Feeding – Top 10 Tips first appeared on Crescent Design.

The post HBLT Care & Feeding – Top 10 Tips appeared first on Crescent Design.

Which is best to Connect Parts for Pressure Testing?

When attaching a part under test to the Hydraulic Burst/Leak Tester (HBLT), the ideal method is a direct connection to the HBLT outlet port. However, when parts are in a safety enclosure or water bath, you must extend the hydraulic path from the HBLT outlet to the part. This usually means adding an extension tube to your fixture.

The main goal is to select tubing that does not affect the test results. The tubing must have sufficient inner diameter to allow some flow without a pressure drop. The tubing should have no or minimal compliance. In addition, any tubing must be easily purged if it is left in place for extended periods. Finally, keep the tubing length as short as possible. Overall tubing compliance worsens with length.
When using the HBLT with a Smart Manifold in parallel mode, take special precautions to insure the sum of the compliance of all ten extension tubes does not affect your test. Use the least compliant tubing and keep the lengths as short as possible.

The ideal tubing is stainless steel tubing with compression fittings. If the flow demands are low, then smaller diameter tubing is easily bent into shapes and attached at both ends with compression fittings. Crescent Design sells an Outlet Plumbing Kit which provides the HBLT user with a quick and easy means for attaching product to the HBLT for testing. For higher flow rates, larger diameter tubing formed with multiple pieces or bent with tubing bending tools works well.

Image may be NSFW.
Clik here to view.

Plastic tubing that is sufficiently non-compliant also works as well. We have found that Qosina part number 33018 is a good substitute to stainless steel for some applications. It is made of two coextruded plastics that have little compliance but are flexible. This tubing works well with water baths where the parts are attached and then moved into the water bath for testing. The flexibility of the plastic is superior to the fixed shape stainless steel tubing in this application.

Avoid using braided steel high-pressure tubing. This tubing is extremely compliant until the inner rubber or plastic tube contacts the steel braid. This can affect the ramp rates because of the overall changing compliance characteristics.

If you need to evaluate your tubing selection, request the document Tubing Extension Sets Compliance Study from Crescent Design. This document details testing methods to insure a good tubing selection.

The post Which is best to Connect Parts for Pressure Testing? first appeared on Crescent Design.

The post Which is best to Connect Parts for Pressure Testing? appeared first on Crescent Design.

Burst Testing an Angioplasty Balloon with the Hydraulic Burst Leak Tester

This video demonstrates the Crescent Design Hydraulic Burst Leak Tester and Crescent Design’s Pressure Manager© software being used to burst-test a raw angioplasty balloon.

We see the balloon being filled prior to the actual start of the linear ramp test. When the actual test begins you see that it acquires the ramp rate quickly and maintains 20 psi per second until the balloon bursts.

You can also see that the volume (the lower blue trace) is reported as the balloon expands and stretches. The delivery rate remains fairly constant until the pressure reaches about 50 psi when the balloon begins to expand faster and the volume delivery rate increases. The Hydraulic Burst Leak Tester’s sophisticated control software is automatically increasing the volume delivery to maintain the desired pressure ramp rate.

The Pressure Manager© summary screen displays the pressure and volume values in real time until balloon bursts where it captures the actual burst event pressure of 336.5 psi and the event volume of 1.09cc. The Result Messages shows the test elapsed time of 16.9 seconds.

The post Burst Testing an Angioplasty Balloon with the Hydraulic Burst Leak Tester first appeared on Crescent Design.

The post Burst Testing an Angioplasty Balloon with the Hydraulic Burst Leak Tester appeared first on Crescent Design.

HBLT Troubleshooting Guide

Overview:
This document will cover basic issues that may arise with the HBLT and provide a guide on how to troubleshoot and resolve them. HBLT Troubleshooting Guide PDF

Problem Possible Problem Possible Solution

BURPING

The HBLT is experiencing excessive burping (clicking) when trying to run a test.

The 0 pressure point of the HBLT has drifted. If the HBLT is burping (clicking) excessively it is most likely sitting over +/-2PSI when open to atmosphere. Note: Some burping is common and expected especially if you have a high purge rate set on the HBLT. On average 2 to 4 clicks is fine.

Since the HBLT has drifted off its zero point you will need to calibrate the HBLT. Please review the Owners Manual and see our website at www.Crescentdesign.com and go to the “How To” videos section for a demo video on calibrating the HBLT.

PRESSURE OVERSHOOT

HBLT overshooting the programmed pressure target.

This can be caused by one or more of these issues:

  • Air in the system (most common)
  • Incorrect compliance setting
  • Up Ramp Rate setting too high

Make sure to purge the HBLT under vacuum every morning or before the start of each shift. Run a total of 3 purge cycles under vacuum. Note: Always make sure that your parts are prepped and purged of air for best test results.

Lower the compliance setting

Lower the Ramp Rate

MOTOR STALLED ERROR

When purging the HBLT under vacuum and the “Motor Stalled” error message is displayed.

If the HBLT purges into an open container with nothing attached to the outlet, but the motor stalls when purging under vacuum the HBLT needs to be calibrated.

If this error is displayed while running a test please contact Crescent Design.

Calibrate the HBLT. Please review the Owners Manual and go to www.Crescentdesign.com and navigate to “How To” videos section for a demo video on calibrating the HBLT.

MOTOR OVERHEATING ERROR

When running a test and the “Motor Overheating” error is displayed.

It is possible to get the actuator motor hot during tests that maintain high pressures for long periods of time or during fatigue tests with a large number of cycles. The motor needs to be turned off to cool down.

It is possible to get the actuator motor hot during tests that maintain high pressures for long periods of time or during fatigue tests with a large number of cycles. The motor needs to be turned off to cool down.

Turn off the HBLT. Use a rag or towel to put over the luer connection at the outlet and disconnect it to relieve the pressure. Let the HBLT sit while turned off for 30 minutes to let the motor cool.

PRESSURE LIMIT EXCEEDED ERROR

When running a test and the “Pressure Limit Exceeded” message is displayed.

The hydraulic pressure exceeded the operational limits of the HBLT. The main cause of this problem is mis-calibration.

Target pressure is close to the HBLT limit.

Calibrate the HBLT and run the test again. If the issue persists please contact Crescent Design.

Lower the ramp rate.

THE CYLINDER IS OUT OF WATER CHECK FOR LEAKS

When running a test the “Cylinder is out of water check for leaks” is displayed.

This message is displayed when the actuator reaches the exhaust limit switch while running a test. This can occur if the product leaks, is very compliant, or is compliant and large. The cylinder does not have enough volume to reach the target pressure and maintain it.

Internal HBLT leakage.

If not using a FILL: Check the product for leaks.

Pre-fill the product before running the test.

Try constraining the product to limit its compliance.

Lean HBLT on side and see if any water comes out of enclosure.

A FILL (or PURGE) TIMEOUT HAS OCCURED. PLEASE CALL FOR SERVICE.

During the fill sequence the “Fill Timeout” message is displayed.

The HBLT displays this alert message when the fill operation times out without encountering a limit switch. The timeout value varies depending on the cylinder volume.

Wrong power module inlet power selection.

Install power module voltage selector for 110-120V

FALSE BURST REPORTED

When running a test and the HBLT declares a burst but the product is intact with no failure or leak.

Tubing loose in Tuohy-Borst which allows the tubing to slip in the fitting causing a sudden drop in pressure.

CAUTION: Over tightening the Touhy-Borst fitting can collapse the tubing restricting fluid flow and pressurization of the product under test.

An internal HBLT leak.

Change the compression fitting rubber O-ring often. A damaged O-ring will cause connection issues. Use a quality connector such as the Plasti-Mate Tuohy-Borst made by S4J manufacturing PN# A7530. Mark the balloon stem with a black sharpie right at the connection so you can see if it slips.

It may be necessary to use a hypo tube inside the I.D. of the product tube to allow sufficient compression of the fitting without collapsing the fluid path. This will also ensure repeatable product-to-product test results.

To check the HBLT for leaks, install a metal cap or ball valve directly to the outlet and run a simple ramp test to the maximum pressure of the HBLT and let it dwell for 60 seconds. If it leaks down more than 10% in 60 seconds please contact Crescent Design.

FALSE BURST AT START OF DOWN RAMP

The up burst or down burst setting is too close to the down ramp rate setting.

Increase the down burst rate or decrease the down ramp rate.

Ensure that the compliance settings are correct (not too high).

FALSE BURST AT THE BEGINNING OF A TEST

The initial (starting) pressure is negative (below zero) causing the HBLT to detect a downward pressure decay.

Check HBLT calibration and adjust if necessary. Ensure that zero is adjusted close to zero.

INTAKE LIMIT ERROR

If this error is displayed when running a test it may be caused by the HBLT zero calibration point not being at zero (or close to zero). If zero is off more than 3 PSI the intake limit switch could be reached before reaching zero PSI.

Calibrate the HBLT. Review the Owners Manual and go to www.Crescentdesign.com and navigate to “How To” videos section for a demo video on calibrating the HBLT.

EXHAUST LIMIT ERROR

If this error is displayed it could be one of the following issues:

An HBLT or product leak prevents reaching the target pressure. This allows the HBLT to activate the exhaust limit switch.

The product is too compliant or large for the HBLT to reach the set pressure.

To check the HBLT for leaks, install a metal cap or ball valve directly to the outlet and run a simple ramp test to the maximum pressure of the HBLT and let it dwell for 60 seconds. If it leaks down more than 10% in 60 seconds please contact Crescent Design. Inspect the product for pinhole leaks.

Check maximum volume output of your model HBLT and verify how much volume is needed to test each different product.

The post HBLT Troubleshooting Guide first appeared on Crescent Design.

The post HBLT Troubleshooting Guide appeared first on Crescent Design.

How does Pressure Manager© work with micrometers?

Pressure Manager© is software that coordinates the HBLT (Hydraulic Burst Leak Tester) pressure profiles and micrometer readings. The common method is to command the HBLT to perform a staircase test using either a test or a sequence of commands called a script. At each step in the test, Pressure Manager© requests a micrometer reading after maintaining the pressure. If using a script, Pressure Manager© records pressures and diameter each for each execution of the READ MICROMETER command. During the test or script, Pressure Manager© keeps a table consisting of the desired pressure, the actual pressure and the micrometer reading. Optionally, Pressure Manager© saves the table data in a comma-delimited file for documentation or further analysis.

Pressure Manager© uses two types of micrometers. The first is the Mitutoyo contact micrometer using the PC serial interface. The second is the Keyence optical micrometer using the PC serial interface to the Keyence 7601 micrometer controller. There are several micrometer heads available for measuring different ranges.

Learn more about the Pressure Manager© Software and learn more about the HBLT.

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The post How does Pressure Manager© work with micrometers? appeared first on Crescent Design.

Machine Solutions Inc. acquires Crescent Design Inc.

Crescent Design’s Hydraulic Burst Leak Tester joins a collection of best-in-class testing and manufacturing equipment for medical device manufacturers

FLAGSTAFF, Ariz. – Aug. 25, 2020 – Machine Solutions Inc. has announced that it has acquired the assets and business of Crescent Design Inc. The acquisition brings together two advanced technology providers to the medical device industry. Crescent Design, headquartered in San Diego, designs and manufactures proprietary hydraulic burst leak test equipment, associated accessories and other auxiliary equipment used in the manufacturing of medical devices.

Machine Solutions and its industry-leading brands—MSI, Steeger USA, Vante, PlasticWeld Systems and SEBRA—continue to increase the range of products and services provided for medical device manufacturers. The acquisition of Crescent Design and its Hydraulic Burst Leak Tester adds another ISO 10555 test requirement to the list of catheter testing capabilities within Machine Solutions’ product catalog, and brings a global sales and service team to support and further develop the Crescent Design technology. The acquisition directly aligns with Machine Solutions’ long-term strategy to provide its customers with a single source for diverse equipment and services to meet their development, production and testing validation needs.

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Founder Steven Royce and Value Stream Leader Christina King share their thoughts on what the acquisition means to Crescent customers. Click Image to WATCH VIDEO

“Crescent Design’s Hydraulic Burst Leak Tester is the standard for testing in the catheter manufacturing industry,” said Machine Solutions President Brian Strini. “We are excited to add another best-in-class technology to our testing equipment catalog and look forward to the additional capabilities we can bring to our customers.”

“Over the years, I recognized the parallel paths that Machine Solutions and Crescent Design have shared—both are committed to quality, innovation and customer service, and I felt that we would work well together,” said Crescent Design Vice President and Co-Founder Steven Royce. “This partnership will provide additional resources to allow continued technical product improvements and in-person customer support in more locations around the world.”

Crescent Design President and Co-Founder Jay Sarno added: “This partnership provides us with the engineering resources needed to develop the next generation of market-leading burst leak testing equipment that will have improved accuracy, be easier to use and be compatible with emerging 21-CFR part 11 compliant test systems.”

Crescent Design is Machine Solutions’ fifth acquisition since joining the BW Forsyth Partners family of companies in 2012.

 

 ABOUT MACHINE SOLUTIONS INC.

Machine Solutions Inc. is the premier provider of advanced equipment and services to the medical device industry. The unified brands of MSI, Steeger USA, Vante, PlasticWeld Systems and SEBRA provide a breadth of products to support customer needs and growth. Machine Solutions provides superior customer experiences by focusing on delivering quality and value, and by dedicating resources to its aftermarket team for technical service and process support. Machine Solutions has been instrumental in automating manual processes in catheter and stent manufacturing operations and the broader medical device industry. Machine Solutions is privately owned by BW Forsyth Partners, a Barry-Wehmiller company. For more, go to machinesolutions.com.

 

ABOUT BW FORSYTH PARTNERS

BW Forsyth Partners is the investment arm of multibillion-dollar global manufacturing and engineering consulting firm Barry-Wehmiller. Established in 2009, BW Forsyth Partners blends Barry-Wehmiller’s unparalleled legacy of value creation and people-centric culture development with keen investing experience to help companies realize their true potential. With a focus limited to areas known well, BW Forsyth Partners seeks to partner with leadership teams to acquire small- to middle-market companies in the capital and component equipment, and professional services sectors. In each of our operating companies, BW Forsyth Partners deploys operational improvements and strategy development without compromising the autonomy, strategic vision and entrepreneurial spirit of their leadership teams. For more information, visit bwforsyth.com.

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The post Machine Solutions Inc. acquires Crescent Design Inc. appeared first on Crescent Design.


HBLT can be used for ISO 594-1 and 2 compliant testing

In the past few years, there have been several inquiries regarding the HBLT’s ability to perform tests that comply with different ISO standards. Crescent Design’s HBLT can perform tests that are ISO 594 compliant. The HBLT can be programmed to perform the test method described in ISO 594-1 and 2, section 5.2 (test method for liquid leakage from fitting assembly under pressure). The HBLT can detect a “leakage sufficient to form a falling drop” as required by ISO 594.

The video shows the HBLT being used in conjunction with Pressure Manager Software so that the ISO 594 compliant test can be visualized.

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HBLT Care & Feeding – Top 10 Tips

Follow these Top 10 tips to ensure optimal performance of your HBLT.

  • Warm up HBLT for 24 hours prior to calibration
  • Always leave your HBLT turned on
  • Purge the HBLT every day using a syringe or the Vacuum Purger
  • Make sure the fluid supply is on the same surface as the HBLT
  • Insure the water reservoir is vented
  • Keep the water reservoir clean
  • Only use fingers to operate the touch screen
  • Document passcode information
  • Fasten all serial port cable connections with the shell screws
  • Do not use, store or ship the HBLT in freezing temperatures

HBLT User Quick Tips PDF

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The post HBLT Care & Feeding – Top 10 Tips appeared first on Crescent Design.

Which is best to Connect Parts for Pressure Testing?

When attaching a part under test to the Hydraulic Burst/Leak Tester (HBLT), the ideal method is a direct connection to the HBLT outlet port. However, when parts are in a safety enclosure or water bath, you must extend the hydraulic path from the HBLT outlet to the part. This usually means adding an extension tube to your fixture.

The main goal is to select tubing that does not affect the test results. The tubing must have sufficient inner diameter to allow some flow without a pressure drop. The tubing should have no or minimal compliance. In addition, any tubing must be easily purged if it is left in place for extended periods. Finally, keep the tubing length as short as possible. Overall tubing compliance worsens with length.
When using the HBLT with a Smart Manifold in parallel mode, take special precautions to insure the sum of the compliance of all ten extension tubes does not affect your test. Use the least compliant tubing and keep the lengths as short as possible.

The ideal tubing is stainless steel tubing with compression fittings. If the flow demands are low, then smaller diameter tubing is easily bent into shapes and attached at both ends with compression fittings. Crescent Design sells an Outlet Plumbing Kit which provides the HBLT user with a quick and easy means for attaching product to the HBLT for testing. For higher flow rates, larger diameter tubing formed with multiple pieces or bent with tubing bending tools works well.

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Plastic tubing that is sufficiently non-compliant also works as well. We have found that Qosina part number 33018 is a good substitute to stainless steel for some applications. It is made of two coextruded plastics that have little compliance but are flexible. This tubing works well with water baths where the parts are attached and then moved into the water bath for testing. The flexibility of the plastic is superior to the fixed shape stainless steel tubing in this application.

Avoid using braided steel high-pressure tubing. This tubing is extremely compliant until the inner rubber or plastic tube contacts the steel braid. This can affect the ramp rates because of the overall changing compliance characteristics.

If you need to evaluate your tubing selection, request the document Tubing Extension Sets Compliance Study from Crescent Design. This document details testing methods to insure a good tubing selection.

The post Which is best to Connect Parts for Pressure Testing? first appeared on Crescent Design.

The post Which is best to Connect Parts for Pressure Testing? appeared first on Crescent Design.

Burst Testing an Angioplasty Balloon with the Hydraulic Burst Leak Tester

This video demonstrates the Crescent Design Hydraulic Burst Leak Tester and Crescent Design’s Pressure Manager© software being used to burst-test a raw angioplasty balloon.

We see the balloon being filled prior to the actual start of the linear ramp test. When the actual test begins you see that it acquires the ramp rate quickly and maintains 20 psi per second until the balloon bursts.

You can also see that the volume (the lower blue trace) is reported as the balloon expands and stretches. The delivery rate remains fairly constant until the pressure reaches about 50 psi when the balloon begins to expand faster and the volume delivery rate increases. The Hydraulic Burst Leak Tester’s sophisticated control software is automatically increasing the volume delivery to maintain the desired pressure ramp rate.

The Pressure Manager© summary screen displays the pressure and volume values in real time until balloon bursts where it captures the actual burst event pressure of 336.5 psi and the event volume of 1.09cc. The Result Messages shows the test elapsed time of 16.9 seconds.

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The post Burst Testing an Angioplasty Balloon with the Hydraulic Burst Leak Tester appeared first on Crescent Design.

HBLT Troubleshooting Guide

Overview:
This document will cover basic issues that may arise with the HBLT and provide a guide on how to troubleshoot and resolve them. HBLT Troubleshooting Guide PDF

Problem Possible Problem Possible Solution

BURPING

The HBLT is experiencing excessive burping (clicking) when trying to run a test.

The 0 pressure point of the HBLT has drifted. If the HBLT is burping (clicking) excessively it is most likely sitting over +/-2PSI when open to atmosphere. Note: Some burping is common and expected especially if you have a high purge rate set on the HBLT. On average 2 to 4 clicks is fine.

Since the HBLT has drifted off its zero point you will need to calibrate the HBLT. Please review the Owners Manual and see our website at www.Crescentdesign.com and go to the “How To” videos section for a demo video on calibrating the HBLT.

PRESSURE OVERSHOOT

HBLT overshooting the programmed pressure target.

This can be caused by one or more of these issues:

  • Air in the system (most common)
  • Incorrect compliance setting
  • Up Ramp Rate setting too high

Make sure to purge the HBLT under vacuum every morning or before the start of each shift. Run a total of 3 purge cycles under vacuum. Note: Always make sure that your parts are prepped and purged of air for best test results.

Lower the compliance setting

Lower the Ramp Rate

MOTOR STALLED ERROR

When purging the HBLT under vacuum and the “Motor Stalled” error message is displayed.

If the HBLT purges into an open container with nothing attached to the outlet, but the motor stalls when purging under vacuum the HBLT needs to be calibrated.

If this error is displayed while running a test please contact Crescent Design.

Calibrate the HBLT. Please review the Owners Manual and go to www.Crescentdesign.com and navigate to “How To” videos section for a demo video on calibrating the HBLT.

MOTOR OVERHEATING ERROR

When running a test and the “Motor Overheating” error is displayed.

It is possible to get the actuator motor hot during tests that maintain high pressures for long periods of time or during fatigue tests with a large number of cycles. The motor needs to be turned off to cool down.

It is possible to get the actuator motor hot during tests that maintain high pressures for long periods of time or during fatigue tests with a large number of cycles. The motor needs to be turned off to cool down.

Turn off the HBLT. Use a rag or towel to put over the luer connection at the outlet and disconnect it to relieve the pressure. Let the HBLT sit while turned off for 30 minutes to let the motor cool.

PRESSURE LIMIT EXCEEDED ERROR

When running a test and the “Pressure Limit Exceeded” message is displayed.

The hydraulic pressure exceeded the operational limits of the HBLT. The main cause of this problem is mis-calibration.

Target pressure is close to the HBLT limit.

Calibrate the HBLT and run the test again. If the issue persists please contact Crescent Design.

Lower the ramp rate.

THE CYLINDER IS OUT OF WATER CHECK FOR LEAKS

When running a test the “Cylinder is out of water check for leaks” is displayed.

This message is displayed when the actuator reaches the exhaust limit switch while running a test. This can occur if the product leaks, is very compliant, or is compliant and large. The cylinder does not have enough volume to reach the target pressure and maintain it.

Internal HBLT leakage.

If not using a FILL: Check the product for leaks.

Pre-fill the product before running the test.

Try constraining the product to limit its compliance.

Lean HBLT on side and see if any water comes out of enclosure.

A FILL (or PURGE) TIMEOUT HAS OCCURED. PLEASE CALL FOR SERVICE.

During the fill sequence the “Fill Timeout” message is displayed.

The HBLT displays this alert message when the fill operation times out without encountering a limit switch. The timeout value varies depending on the cylinder volume.

Wrong power module inlet power selection.

Install power module voltage selector for 110-120V

FALSE BURST REPORTED

When running a test and the HBLT declares a burst but the product is intact with no failure or leak.

Tubing loose in Tuohy-Borst which allows the tubing to slip in the fitting causing a sudden drop in pressure.

CAUTION: Over tightening the Touhy-Borst fitting can collapse the tubing restricting fluid flow and pressurization of the product under test.

An internal HBLT leak.

Change the compression fitting rubber O-ring often. A damaged O-ring will cause connection issues. Use a quality connector such as the Plasti-Mate Tuohy-Borst made by S4J manufacturing PN# A7530. Mark the balloon stem with a black sharpie right at the connection so you can see if it slips.

It may be necessary to use a hypo tube inside the I.D. of the product tube to allow sufficient compression of the fitting without collapsing the fluid path. This will also ensure repeatable product-to-product test results.

To check the HBLT for leaks, install a metal cap or ball valve directly to the outlet and run a simple ramp test to the maximum pressure of the HBLT and let it dwell for 60 seconds. If it leaks down more than 10% in 60 seconds please contact Crescent Design.

FALSE BURST AT START OF DOWN RAMP

The up burst or down burst setting is too close to the down ramp rate setting.

Increase the down burst rate or decrease the down ramp rate.

Ensure that the compliance settings are correct (not too high).

FALSE BURST AT THE BEGINNING OF A TEST

The initial (starting) pressure is negative (below zero) causing the HBLT to detect a downward pressure decay.

Check HBLT calibration and adjust if necessary. Ensure that zero is adjusted close to zero.

INTAKE LIMIT ERROR

If this error is displayed when running a test it may be caused by the HBLT zero calibration point not being at zero (or close to zero). If zero is off more than 3 PSI the intake limit switch could be reached before reaching zero PSI.

Calibrate the HBLT. Review the Owners Manual and go to www.Crescentdesign.com and navigate to “How To” videos section for a demo video on calibrating the HBLT.

EXHAUST LIMIT ERROR

If this error is displayed it could be one of the following issues:

An HBLT or product leak prevents reaching the target pressure. This allows the HBLT to activate the exhaust limit switch.

The product is too compliant or large for the HBLT to reach the set pressure.

To check the HBLT for leaks, install a metal cap or ball valve directly to the outlet and run a simple ramp test to the maximum pressure of the HBLT and let it dwell for 60 seconds. If it leaks down more than 10% in 60 seconds please contact Crescent Design. Inspect the product for pinhole leaks.

Check maximum volume output of your model HBLT and verify how much volume is needed to test each different product.

The post HBLT Troubleshooting Guide first appeared on Crescent Design.

The post HBLT Troubleshooting Guide appeared first on Crescent Design.

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