Medical Device Leak Testing

 
 

Testing medical devices such as catheters, tubing sets and fluid bags for leaks and/or blockages is critical for patient safety. CTS offers instruments to address a range of test methods and requirements, such as enabling compliance with 21 CFR Part 11 EU Annex 11, providing systems for benchtop or automated assembly operation, while meeting the specific testing requirements for your medical device.

Leak Testing of Disposable Medical Devices

Medical devices come in different sizes and often feature complex geometries such as tubes, valves and other components that can make testing more challenging. The flexibility and elasticity of silicone and other common polymer-based medical device materials can also impact test pressure. To address the complexities, medical device leak testers must provide effective sealing and the correct amount of pressure and sensitivity to produce accurate test results. Choosing the optimum medical leak testing method and equipment is also important.

VIDEO: Sentinel Blackbelt Pro leak test instrument for pressure testing medical bags
 

Pressure Decay and Mass Flow Testing for Detecting Leaks and Blockages in Medical Devices

Products from CTS include a variety of medical device testing equipment solutions that provide reliable results in fast cycle times. The two most common methods of medical leak testing include pressure decay and mass flow techniques. Both can be conducted using our medical device leak testers, such as the single-channel Blackbelt or multi-channel Blackbelt Pro that supports 21 CFR Part 11 and EU Annex 11.


What Is the Difference Between Pressure Decay and Mass Flow Medical Leak Testing?

Pressure decay testing involves pressurizing the component and then isolating it from the pressure source. If a leak is present, the air will move from a high-pressure area to a low-pressure area, resulting in a decrease in overall pressure that is then measured by the equipment.
 
Mass flow leak testing involves pressurizing the component and then monitoring the amount of air flowing into the part. The medical device leak tester then detects the presence of a leak by measuring how much air is required to maintain the internal pressure. The higher the volume of air required, the larger the leak. 

We will help you choose the right test method for your test.


Inspecting Medical Devices for Blockages

For parts that need to be tested for partial or complete blockages, CTS provides options using backpressure occlusion, pressure decay or mass flow. A single Blackbelt or Blackbelt Pro instrument can be used to conduct both leak test and blockage tests. Browse our application stories for examples such as blockage testing multilumen catheters, cannula/needles and vascular access sheaths.
 

Reliable Leak Testing Solutions for the Medical Industry

What sets CTS apart is our extensive knowledge of medical device testing applications, process validation, data collection and storage, calibration, and test specifications. We understand the stringent equipment testing guidelines and provide reliable medical device leak testers that can be configured based on your exact needs.
 
We work confidentially with partners ranging from global corporations to small, specialized startup ventures. Our team has extensive experience in testing equipment and will work with you to develop a medical leak testing solution that is specifically tailored to your unique needs.
 
Contact us to learn more about our medical leak testing equipment and solutions or to discuss your unique disposable device testing requirements. 

Leak Test Equipment Options for Respiratory, Cardiovascular, Diagnostic and Other Medical Devices

We will work with you to determine which equipment and testing method is right for your unique medical device leak testing needs. Contact us to discuss your medical equipment testing requirements. 
  • Catheter Testing Solutions: Cincinnati Test Systems offers many catheter testing options, including leak test devices for balloon catheters and multi-lumen catheters. 
    • Non-Compliant Balloon Catheters: Used in stent delivery, PTA/PTCA, dilation, and more. Test methods vary slightly for stented vs non-stented versions but both can be managed by the same instrument. Most require pressure decay with nitrogen or compressed air.
    • Multi-Lumen Catheters: Used in hemodialysis, diagnostics, pacing, drug delivery, CVC, PICC, and various other applications. These catheters are often tested using both pressure decay for leak testing and mass flow using multi-port instruments for blockage testing on each individual lumen.
  • Respiratory Breathing Tubes/Circuits: Often manufactured from corrugated polymer tubing, common variants include single limb, dual limb, coaxial in both heated and non-heated variants. Tubes typically require positive pressure mass flow leak testing.
  • Medical Solution, Fluid or Blood Bags: Used for IV/saline, hemodialysis, blood transfer, urinary/waste collection, and more. Bag testing is often performed using pressure decay with restraining plates.
  • Medical One-Way Check Valves: Used in drug/fluid delivery, hemodialysis, blood transfer, and more. Different tests can be performed, including anti-reflux valve leak, body weld leak, below cracking pressure valve leak, above cracking pressure valve opening verification, and actual cracking pressure test.
  • Vascular Access SheathsUsed for guidewire and catheter entry into blood vessels, these devices require leak and blockage testing. Testing is done using pressure or vacuum.
  • Microfluidic ChipsAlso known as lab-on-a-chip or microfluidic cartridges, they are used in a multitude of biological diagnostic applications, including analytical separation, detection, fluid control (sampling/mixing) and more. They commonly require a two-step process to detect leaks and potential blockages on each unique microfluidic pathway within each tip.
  • Cannula/Needles and Flow Selection/Regulation Devices: These devices primarily provide a pathway for the administration or collection of solutions, blood and fluids. Typical manufacturing issues are related to the adhesive bonding, extrusion, and cut length processes.
  • Tubing Sets: Used in drug and solution delivery, blood transfer, and more. Set testing is often performed using pressure and/or vacuum decay testing and occlusion testing.
 

Request a quote for medical device leak testers or contact us today to discuss our medical device testing equipment and solutions.