Leak Testing Case Studies: Small Medical Device Leak Test Machine

Client: Multi-National Medical Device Manufacturer

Part: Sealed Medical Device

Machine supplied: Automatic leak test system for swallowable devices

Overview: This system was designed and manufactured in order to give the customer the ability to 100% leak test sealed medical devices within their production environment. TQC developed this system alongside the client to allow them to increase throughput and leak test to a smaller leak limit

This is a medical device leak testing facility, designed to leak test a sealed medical device in a pressurised chamber. Leak testing is key to the manufacture of quality medical devices and since this product is a device that can be swallowed, health and safety considerations dictate that accurate test and inspection is critical to high quality production of the end product.

Smaller devices require a higher degree of accuracy and this test is to a limit which is intended to ensure that no inward leakage will occur at pressures up to 0.5 bar differential. An air leakage limit of the order of 20 mm3/sec is considered to meet this requirement and the actual equipment is set to operate below this value.

The medical devices are sealed with an enclosed internal volume, therefore the test method is to enclose the capsule in a pressurised chamber and measure any pressure decay due to leakage in the capsule. this is done using the standard air decay sequence of a leak test instrument. However, in order to check for gross leaks (which would equalise pressure internally and therefore invalidate the test) a dosing system is added to the basic instrument.

The test fixture is a simple bench mounting unit with a slide in drawer containing the lower half of the test chamber. The upper half is clamped by a pneumatic cylinder which can only operate when the drawer is fully closed. Once the drawer is closed, an interlock valve is operated which allows a pneumatic signal from the instruments auto connector output to operate the cylinder via a pilot operated valve.

TQC welcomes the opportunity to design and manufacture complete medical leak test systems to client specifications, whether you have a simple bench top application or a more complex automated leak test requirement. Contact our engineers to advise you on your automation project.

To find out more about how we can help you with your leak testing requirements:

We build all machines in-house, applying our 25+ years experience in specialised test and automated handling machines experience to the engineering projects we undertake. We offer customer support, backup and service call-out for all projects, whatever the size.

Get in touch with us to discuss your requirements and we will be happy to offer our professional advice and visit you at your site.

TQC Ltd, Hooton Street, Carlton Road, Nottingham, NG3 2NJ, United Kingdom
Tel: +44 (0)115 9503561   |   Fax: +44 (0)115 9484642   |   E-mail: sales@tqc.co.uk