PHA and FMEA Evaluation Program


Members of our pharmaceutical team have provided risk management tools, such as Process Hazard Analysis (PHA) and Failure Mode Effect Analysis (FMEA), for manufacturing and facility equipment at a Fortune 100 Pharmaceutical Company. Our systems, N2Plant supply monitoring and relieving systems, confirmation of production equipment operating limits, and product Lower Explosive Levels.

This FDA approved 40,000 sq-ft. pharmaceutical manufacturing facility dispenses, sizes, mixes blends dries compresses, and coats pharmaceutical tablets and capsules, which supplies multiple countries.

Equipment Included in the Analysis:

  • Micro Motion FMS
  • Contrec Controller
  • Glatt Particle Coater
  • Zenith Pump, etc.

Valdes Employees Are Familiar with the Following:

  • International Standard IEC 60812 Techniques for FMEA
  • International organization for Standardization (ISO)
  • International Society for Pharmaceutical Engineers (ISPE)
  • Independent Project Analysis (IPA)