Medical Device Leak & Flow Testing Solutions
Medical Devices
Precision Leak & Flow Testing for Catheters, Drug Packaging & Surgical Instruments
Medical device sealing failures are not quality events — they are patient safety events. Figurtech's differential pressure and mass flow instruments are used by medical device manufacturers to validate catheter integrity, drug vial seals, surgical instrument sealing, and infusion tubing flow rates to ISO 11608 and ISO 11135 process requirements.
The Manufacturing Challenge
Medical components test at low pressures (10–200 kPa), with sub-SCCM leak specifications and volume tolerances that defeat direct pressure methods. Environmental noise — temperature drift, supply pressure variation — can mask or mimic leakage signals. Every test record must be traceable, and validation documentation must satisfy 21 CFR Part 11 or equivalent quality requirements.
- Soft-wall tubing and catheters: thin-wall, small volume, micro-leak detection
- Drug vials and packaging seals: sub-SCCM leak limits, high-volume in-process testing
- Surgical clamps and disposable instruments: low-pressure cavity validation
- IV infusion sets and delivery micro-channels: both leak and flow rate specification
Recommended Instruments
| Series | Best for | Key capability |
|---|---|---|
| LD Series | Catheters, vial seals, surgical instruments | 10× sensitivity vs direct pressure, common-mode noise rejection, 0.01 kPa resolution |
| LF Series | IV tubing, micro-channels, breathable membranes | Direct flow measurement 0–50 L/min, 0.01 sccm resolution, dual OK/NG window |
| LY Series | Rigid housings, sealed instruments at higher pressures | 0–1200 kPa, 0.1 Pa resolution, temperature compensation |
Typical Applications
- Catheter airtightness (ISO 11608): LD differential pressure test, sub-SCCM detection at 20–50 kPa, validated against calibrated standard leak
- Drug vial seal validation: LD inline test, 100% coverage, per-unit data log with batch and serial number
- IV tubing flow characterization: LF mass flow test, 0–5 L/min range, upper and lower flow limits define pass/fail window
- Surgical clamp head sealing: LD low-pressure (15 kPa) differential test, noise rejection confirms small-cavity integrity
- Breathable membrane validation: LF direct flow measurement, PTFE membrane flow resistance characterization at controlled backpressure
Why Figurtech for Medical?
- Validated against ISO standards: Test parameter documentation and standard leak calibration support process validation requirements
- Sub-SCCM sensitivity: LD and LF instruments detect leaks and flow deviations well below typical medical device acceptance criteria
- Noise rejection architecture: LD's bridge compensation removes ambient interference without software filtering — a hardware guarantee
- Complete data traceability: Per-unit serial logging, SPC export, USB/RS-485/Ethernet output for LIMS or MES connection
- Custom fixture tooling: Soft-jaw catheter fixtures, vial nest tooling, and tubing clamp fixtures designed and validated with standard leaks before delivery
Working to a specific ISO standard or leak rate spec? Share your test requirement and we will confirm the correct instrument and fixture configuration.
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