Quality

Quality Assurance

— Quality ASSURANCE —

Umech operate an extensive Quality Management System based on ISO:9001 with a focus on;
Continuous improvement - Customer satisfaction - Operational consistency

We work with customers to develop and approve customised Quality & Project Plans (QPP’s) or Inspection and tests plans (ITP’s) appropriate for your project. Our capabilities range from Pharmaceutical industry level cGMP/GDP validation programs including IQ/OQ/PQ right down to basic system walkdown punch lists. Applications include:
Healthcare & Pharmaceutical Industries
High-Purity Gases & Systems
Ultra-high purity semiconductor fabs

Pressure Testing

Standard purity and Ultra High Purity (UHP) pressure testing.
Gas system stress testing for high pressure filling and mixing applications.
Line tracing using fluid continuity checks.
Leak testing using high accuracy digital pressure monitoring instruments.

Helium Leak Detection

Utilising mobile, state of the art equipment to achieve leak rates of up to1x10-11mbar/l/s for standard stainless steel and UHP gas systems. Weld integrity testing for hazardous, high purity gas delivery systems. Highest accuracy leak detection available on the market, quickly find the smallest leaks while maintaining system purity. Outboard (sniffer) helium leak testing is also available.

Moisture Testing

Oxygenated contaminants such as water vapor in materials used and in the wafer environment are primary causes of defects and process variations that compromise yield.

Cavity Ring-Down Spectrometer (CRDS) can perform H2O analysis over a vast range: 12 ppb to 2000 ppm in N2!

Calibration/Verification of Dew Point sensors
Confirmation of line moisture contribution
Verification of recovery of system purity after air ingress or planned line break operations.

Particle Count Testing

Umech can test your gas system for particle contamination in the range of 0.3 - 10 𝜇um, including isokinetic sampling capability. Our test unit is designed to be integrated into your environmental monitoring program. Rooms and custom sample recipes can help to automate and simplify your monitoring routine.

0.3um to 10um particle size range - 6 particle size channels (standard)
Built-in ultra quiet long-life vacuum pump, with HEPA filtered exhaust
A totally sealed pharmaceutical grade Polycarbonate blend enclosure which is easy to wipe down and is fully VHP compatible
Fully 21CFR part 11 compliant
Built-in cleanroom certification reports
NATA certified calibration

Passivation

Umech can perform passivation on your systems to help remove surface contamination, reduce downtime and extend maintenance intervals.

Nitric or Citric acid process
Purpose-built skids available
Safe, efficient and controlled passivation and flushing process for your facility
Passivation for pharmaceutical plants, vaccine manufacturing facilities, Hydrogen generation facilities and purified water systems.
Less risk of contamination-related production losses and unplanned system shutdowns

Validation

Our validation methodology is based around the Validation V-model and can be customised to suit various industries.