Quality Leak Testing in Medical Manufacturing

Quality Leak Testing in Medical Manufacturing

Quality Leak Testing in Medical Equipment

Leak testing medical devices is crucial to any medical equipment manufacturing operation. Zaxis is here to help. Our experts discuss medical devices that benefit from leak testing, outline our leak testers for medical equipment, and help you deliver the best medical devices to your clients. All our testers are FDA/ASTM compliant and provide high-quality leak testing for medical equipment.

Leak Testing Medical Devices for Critical Applications

Medical devices must meet stringent regulatory guidelines while meeting client demands to do more in less time and at a higher level than previous models. Leak testing can help you meet these demands to create precision medical components for potentially life-saving applications, such as:

  • Aspirators
  • Bags and filters
  • Blood bags
  • Blood dialyzers and devices
  • CPAP tube
  • Bubble points
  • Catheters
  • Centrifuges
  • Chemotherapy pumps
  • And many other essential medical devices!

Leak Testers for Medical Devices

Leak testers for medical equipment must be highly sensitive, accurate, and purpose-built for the medical manufacturing industry. Many feature configurable designs, making them ideal for any medical application, from disposable supplies to diagnostic equipment to large devices and beyond.

To keep your medical equipment delivering quality results, it’s essential to find a leak tester manufacturer you can trust and who offers a broad selection of pressure ranges, flow rates, and the ability to have multiple channels or test types in a single tester. Zaxis is proud to offer a variety of FDA/ASTM-compliant leak testers that can be used to confirm quality medical devices are leaving your facility. We offer:

  • Zaxis PD. A wall-mounted, low-cost, single-channel alternative for manufacturing cell configurations.
  • iKit. Save on space with this tester’s slim, compact design with enhanced automation abilities.
  • Isaac HD. Features a modular design and hardworking capabilities.
  • Zaxis 7i. The large feature capacity includes an easy-to-use color touchscreen.

All our leak testing products for medical devices are configurable, accurate, and repeatable. We are your perfect solution for quality leak testing in medical manufacturing.

Your Top Source for FDA/ASTM-Compliant Leak Testers for Medical Equipment

Zaxis is your top provider of leak testing equipment for medical devices and other industries. We only offer the highest quality products, meaning seals that don’t burst, joints that don’t break, containing what needs to be contained, and protecting what needs to be protected. When your products are used to save lives, nothing less than the best is acceptable. How do you ensure that you only produce the best? You test!

To learn more about how Zaxis can take your medical device manufacturing operation to the next level through our quality leak testing products for medical equipment, contact us or call 801-264-1000 to speak to one of our sales engineers today. We’re ready to show you how we can help ensure your production process only generates the best.

Built for You

Contact us today to find the right solution for your needs.

Leak Testers

The modular design of Zaxis leak testers enables us to meet the demands of a wide variety of applications.

buffers and reagents for covid-19 testing

Medical Manufacturing Solutions

We have leak testing solutions for multi-lumen catheters, IV sets, implantable devices and much more.

Pressure and Vacuum in one iKit Leak Tester

Pressure and Vacuum in one iKit Leak Tester

Pressure and Vacuum in one iKit Leak Tester

iKit

A slim, compact design that saves on valuable manufacturing space. Easy to concatenate together for automation.

Zaxis Leak Tester in Action

Watch Zaxis Leak Tester Now https://vimeo.com/581246944 Zaxis Leak Tester integrated into a customer robotic application See how one customer integrated a Zaxis leak tester into a robotic application? Zaxis leak testers are configurable, accurate and repeatable....

Quality Leak Testing in Medical Manufacturing

Quality Leak Testing in Medical EquipmentLeak testing medical devices is crucial to any medical equipment manufacturing operation. Zaxis is here to help. Our experts discuss medical devices that benefit from leak testing, outline our leak testers for medical...

Covid 19 Response Thank You from Air Logic

In response to Covid 19 many companies had to react and adapt quickly. Air Logic sent our employees this wonderful thank you video.

The Ideal Gas Law & Leak Testing Video

During leak testing, changes in pressure can occur due to changes in temperature, volume, and number of moles of the gas.

Configure a Leak Tester

Contact us today to find the right solution for your needs.
Pressure Decay Leak Testing in Automation

Pressure Decay Leak Testing in Automation

Pressure Decay Leak Testing in Automation

In automated manufacturing many assembled products require leak testing to validate product viability and quality. A leak test is used to determine if an assembled object, product, or system functions within a specified leak limit. Leaks occur when gas or liquid flow through an object via an imperfection or manufacturing defect such as holes, cracks, weak seals, etc.

The automation of leak testing generates several key challenges, such as real estate on a production line, strict quality standards, efficient productivity, as well as communication and data sharing with the rest of the automation equipment.

Configure a Leak Tester

Contact us today to find the right solution for your needs.

Proximity is Key

Square footage on a production line is valuable and costly. Leak testers are often integrated into assembly lines however they best fit. Many standard pressure decay leak testers measure over 12” wide. A common solution for integration is to extend the connection hoses between the part under test and the leak tester which can be several feet away. The longer the connection tubing, the more volume is used in a leak test, which can have a devastating effect on productivity as well as the accuracy of leak tests.

The volume of air used in a leak test includes the internal volume of the tester, the volume contained in all of the connection tubing, as well as the volume of the product under test. The farther a leak tester is from the part under test the larger the test volume. The larger the volume the longer the volume takes to pressurize which negatively effects productivity and throughput.

A higher test volume can also impede the leak testers ability to detect a leak. Think of this in terms of tires. You have a car tire which holds a large volume and a bike tire which holds a small volume. If both tires run over the same nail, what happens? The bike tire flattens almost immediately while the car tire slowly loses air over time. The smaller the test volume the faster and easier it is to detect a leak. The larger the test volume the longer it takes to identify if there is a leak, meaning extended test times with a lower accuracy of detection.

In terms of instrumentation, when running a pressure decay test, the value attributed to the pressure decay is the digital signal from the pressure sensor. When testing objects with the same size hole, such as a bike and car tire, the object with the larger test volume (car tire) will translate into a smaller signal than an object with a smaller test volume (bike tire). The pressure decay value is directly proportional to volume. Smaller signals require more time to detect a leak. Electrical, pneumatic, thermal or atmospheric effects, or noise, can mask small signals as well as influence the pressure decay value which has a negative impact on repeatability. A smaller total test volume yields a larger relative pressure decay value/signal and requires less test time. The greater the magnitude of the signal above zero, the better signal to noise ratio, which directly results in higher test accuracy and repeatability.

Moving the leak tester closer to the part under test will decrease test time and increase accuracy which raises both quality and throughput. The challenge is how to narrow that proximity when space is so limited? The answer is the iKit by Zaxis. At 1/4th the size of most pressure decay leak testers the iKit was designed specifically to fit within close proximity to the product under test on an assembly line. At only 3” wide the iKit can be mounted right on tooling saving valuable space and reducing excess test volume that is created by the use of extended hoses.

[et_pb_image_n10s _builder_version=”3.18.8″ src=”https://zaxisinc.com/wp-content/uploads/thumbnail_image002.jpg” n10s_type=”cali” title1_overlay=”Standard” title2_overlay=”Leak Testers” caption_overlay=”require a lot of real estate” image_as_url=”off” overlay_orientation=”to right” overlay_orientation_hover=”to right” image_alpha=”0.95″ image_alpha_hover=”0.65″ background_color=”#000000″ show_in_lightbox=”on” /]
[et_pb_image_n10s _builder_version=”3.18.8″ src=”https://zaxisinc.com/wp-content/uploads/thumbnail_image001.jpg” n10s_type=”cali” title1_overlay=”iKit” title2_overlay=”Automated Leak Testers” caption_overlay=”saves space and lowers test volume” image_as_url=”off” overlay_orientation=”to right” overlay_orientation_hover=”to right” image_alpha=”0.95″ image_alpha_hover=”0.65″ background_color=”#000000″ show_in_lightbox=”on” /]

Communication

Effective automation relies on effective communication. There are many components that go into an automated production line, all of which need to be able to talk to each other. Once a leak tester runs its test it needs the ability to communicate results or trigger events such as Pass=Next, Fail=Eject or Fail=Halt Production.

There are many forms of communication commonly used in factory automation including Modbus, Ethernet TCP/IP, and EtherNet/IPTM. The most dynamic of these communication systems is EtherNet/IPTM as it combines traditional Ethernet infrastructure and hardware with both of the most commonly used collections of Ethernet standards, the Internet Protocol suite and IEEE 802.3, and integrating the Common Industrial Protocol. EtherNet/IPTM is the preferred communication system for Allen-Bradley automation equipment.

With factory automation in mind, the purpose-built design of the iKit has the option to include EtherNet/IPTM. Other communication systems such as discrete I/O, RS232 and Ethernet TCP/IP are also available.

EtherNet/IP in Factory Automation

iKit Automation Solution

Zaxis has designed the iKit to be the ideal leak tester for factory automation settings. With the smallest footprint of any pressure decay leak tester on the market combined with integrated Allen-Bradley connectivity, the iKit by Zaxis is an excellent leak test solution for factory automation.

iKit by Zaxis