Quality ASSURANCE

Pharmaceutical Industries - High-Purity Gases & Systems - Ultra-high purity semiconductor fabs

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

Let us develop customised Quality & Project Plans (QPP’s) or Inspection and tests plans (ITP’s) appropriate for your project. Our capabilities include Pharmaceutical industry level cGMP/GDP validation programs including IQ/OQ/PQ .

Pressure Testing

Umech pressure testing verifies the integrity of both standard purity and ultra-high purity (UHP) gas systems — so you can trust performance under the toughest conditions.

• Stress testing: High-pressure fills

• Leak detection: High-accuracy digital monitoring to capture even the smallest pressure loss

• Line tracing: Fluid continuity checks to confirm gases flow exactly as designed

Whether commissioning a new system or validating existing infrastructure, Umech delivers pressure testing you can rely on — with the same precision and assurance trusted by Australia’s leading labs and fabs.

Helium Leak Detection

Umech provides the highest-accuracy leak detection available, giving you confidence that your system is sealed tight before it goes live. Our mobile helium mass spectrometers test to 1×10⁻¹¹ mbar∙L/s. Capable of detecting leaks a billion times smaller than a pinhole. This level of precision ensures:

• Weld integrity in hazardous ultra-high purity gas systems

• Zero contamination risk for semiconductor, pharma, and research applications

• System reliability without costly downtime or rework

Both vacuum (inboard) and sniffer (outboard) helium leak testing are available, depending on your project requirements.

When system integrity is mission-critical, “good enough” isn’t good enough. Umech delivers assurance at the tightest leak detection thresholds in the industry.

Moisture Testing

Even trace levels of water vapour can compromise high-purity processes — causing corrosion, product contamination, and yield loss. Umech’s moisture testing services give you confidence that your systems meet the strictest specifications before start-up:

• High-sensitivity detection: Cavity Ring-Down Spectroscopy (CRDS) H₂O analysis down to 12 ppb

• Verification and calibration: Confirm dew point sensor accuracy and system response

• Line contribution assessment: Identify and eliminate hidden sources of moisture within piping and fittings

• System recovery checks: Verify that purging and conditioning restore required purity levels

From semiconductors to pharma, when dryness defines success, Umech delivers ppb-level assurance.

Particle Count Testing

Our team are experts in testing particle contamination to 0.3 - 10 𝜇um. Our test unit is designed to be integrated into your environmental monitoring program.

• A totally sealed pharmaceutical grade Polycarbonate blend enclosure and is fully VHP compatible

• Fully compliant to 21CFR part 11

• Built-in cleanroom certification reports

• NATA certified calibration

Derouging & Passivation

Umech’s custom built passivation skid can remove internal surface contamination from your piping system.

• Nitric or Citric acid process

• Safe, efficient and controlled passivation and flushing process for your facility

• Pharmaceutical plants, vaccine manufacturing WFI and purified water systems.

• Less risk of contamination-related production losses and unplanned system shutdowns

Commissioning & Validation

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

• User Requirements Specification

• Functional Specification

• Technical specification

• Design Qualification

• Installation Qualification

• Operation Qualification

• Performance Qualification