Medical devices and packaging must perform reliably under the conditions of their intended use – and failure in the field is not an option. Whether testing the integrity of a sterile fluid path, verifying the seal on a drug delivery device, or confirming the flow performance of a respiratory component, manufacturers require instrumentation that delivers consistent, traceable results across every unit on the production line.
Furness Controls has supplied precision leak testing and flow measurement instruments to medical device manufacturers for decades. Our instruments are designed for demanding production environments, with the resolution and repeatability needed to detect the small leakage rates that define the difference between a conforming and non-conforming device.
Standards and Accreditation
Our instruments and calibration services are designed to support the quality and compliance requirements of medical device manufacturers.
Furness Controls holds UKAS accreditation and operates in accordance with ISO/IEC 17025:2017 across our calibration laboratories in the UK, France, Germany, and the US. All calibrations are fully traceable to national standards.
Component |
Test Parameters |
Recommended Products |
|---|---|---|
Check valve for medical tubing |
Pressure decay leak test 2 bar, 2 cc/min |
|
Cleanroom pressure monitoring |
Monitoring and control of room pressure Typical positive pressure of up to 50 Pa (0.2 inH₂O) |
|
Culture growth flasks (e.g. Fernbach Flasks) |
Pressure decay leak test through Gore-Tex membranes Typical allowed air leak of 1.5 cc/min at 2 psi (140 mbar) |
|
DNA test plate |
Pressure decay leak test Multi-cavity plastic moulding Tested at 150 mbar 30 cc/hr leak limit |
|
Respirators |
Pressure decay leak test (tested at vacuum) Flow-checking of inhale and exhale ports |
|
Hospital water supply filtration |
Pressure decay leak test of filter housing at 5 bar, 3 cc/min fail limit. |
|
Respirator filter medium for breathing apparatus |
Back-pressure flow test for filter medium integrity and performance assessment. Low-pressure, high flow. Typical pressures @ 50 mBar and 100-200 l/min flow rates. |
|
Oxygen bottle valves and arrestors |
240 bar indirect testing using air piloted valves and control from leak tester. 15 cc/hr fail limit. |
|
Fume cupboard and medical assembly station differential pressure monitoring |
DP ranges of 0 – 150 Pa, Ranges of 0 – 1000 Pa. |
|
Ophthalmic needles diameters check |
50 mbar 0.5 to 2 l/min |
|
Drug delivery pump assemblies (e.g. insulin delivery). |
Pressure decay leak detection. Typical pressure 250 mBar. Leak fail limits < 0.5 cc./min on very low-test volumes (high DP capability required) |
|
Dialysis cartridge assemblies. Ported chamber leak test and ultrasonic welded membrane leak testing |
Test pressures for manufacturing QA <150mBar, 2 cc/min fail limit. Burst pressure testing for qualification @ higher pressures. |
|
Blood or haematology bags |
Multi-channel sequence testing for throughput improvement. Typical test pressures @ 150 mBar to 500 mBar. Leak rates < 2 cc/min |
|
Urine catheter bags |
Multi-channel sequence testing for throughput improvement. Typical test pressures @ 50 mBar to 200 mBar. Leak rates < 2 cc/min |
|
Negative pressure wound therapy (NPWT) device |
100 to 300 mbar 1 to 4 cc/min |
|
Laryngoscopes |
Contact Us |
|
Arterial balloon catheter |
Up to 28 bar, leak rates variable |
|
Medical endoscope |
Contact Us |
|
hypodermic needles and syringes |
Contact Us |
Looking for a more specialised solution?
We design, manufacture, and calibrate all instruments in-house, with our headquarters in East Sussex and dedicated calibration laboratories in France, Germany and the US. If your application falls outside standard parameters, our engineers can develop a bespoke instrument tailored to your exact test requirements - delivering a complete turnkey solution from specification through to calibration and commissioning.
Have a question, want to find out more, or ready to speak to an engineer?
Have a question, want to find out more, or ready to speak to an engineer about your medical testing requirements?
Get in touch below