Medical Device Leak Testing

Clients: Leading global medical and pharmaceutical companies

Parts: Medical devices and other medical / pharma products

Machines supplied: Leak testing solutions

Overview: These systems were designed and manufactured to provide the customer the ability to leak test their product. This page covers a variety of products and leak test methods to provide an overview of equipment supplied by TQC.

Summarising the leak testing solutions provided over the years by medical device types that we have tested the following –

• Swallowable medical devices
• Wound dressings
• Tracheal tubes
• Surgical devices
• Medical devices
• Medical implants
• Medical filters
• Medical showerheads
• Clinical test devices

Along with these, there are further medical and pharmaceutical based projects handling flexible products, liquid and solid-filled products, and medical devices we cannot disclose. The leak test, automation, and handling equipment provided for these confidential projects is in line with our other solutions and adds to our experience to enable us to help you leak test your product.

The techniques used range from positive air decay, vacuum air decay and dosing leak test systems, and high vacuum evaporation, to the use of hydrogen and helium for tracer gas leak testing. TQC has provided systems for use in clean room applications; tailoring the system, fixture, and any control equipment to suit.

The standard Series 20 drawer solutions have provided the backbone for a number of medical device leak testing systems. The series 20 allows parts to be manually loaded and unloaded, then automatically tested; this is ideal for flexible, fragile, and delicate parts that need to be tested at typically 1 every minute. This cost-effective setup allows for multiple test units to be operated by a single operator.

For high-speed applications, TQC has supplied leak test machines that test multiple parts at once using multiple leak test instruments. We have automatically fed plastic vials from bulk, testing that the vials are watertight. For high-production volume tracheal tubes we have provided a system that allows manual loading of parts onto fixtures which are then transferred through various automatic stations including gross leak testing using air decay and fine helium leak testing using helium test gas within a chamber and a mass spectrometer. Tested parts were automatically unloaded with failed parts segregated as required to ensure only good products were sent to the end user.

Other niche solutions we have provided that include leak testing of medical devices are –

• Interchangeable system for leak testing of various sizes of medical filter
• Showerhead leak test system to check ultrasonic weld process
• Medical implant sealed part leak testing
• Pre-packed contact lens integrity testing

For more examples of leak test solutions visit our other pages, all our air decay systems can be configured for either over-pressure, vacuum, or dosing applications depending on your leak testing requirements. Alternatively, we can offer tracer gas-based equipment using helium or hydrogen as the test gas.