Qualification Services

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Meet industry standards with Vertex Qualification Services

When quality and reliability matter most, even the smallest error can have serious consequences. At Vertex, we ensure your equipment performs with precision and your environments remain fully compliant, helping you consistently deliver safe, high-quality products with confidence.

Services

Qualification Services at Every Step

At Vertex, we ensure that your cleanrooms, operation theaters, and critical equipment meet all required specifications and regulatory standards through comprehensive onsite qualification. Our approach provides clear, documented evidence across every stage from design and installation to operation and performance ensuring full compliance and reliability.

Installation Qualification (IQ)

We verify that equipment, along with all components and documentation, is properly installed and configured in accordance with defined requirements.

Operational Qualification (OQ)

We test all key functions and components to confirm that the system operates as intended under specified conditions.

Performance Qualification (PQ)

We evaluate the system over time to ensure it consistently performs within defined parameters and delivers reliable, repeatable results.

Validation services at every step

Thermal and sterilization equipment from -195°C to 1100°C

  • Climatic Chambers
  • Refrigerators
  • Freezers & Ultra-Low Freezers
  • Refrigeration Chambers
  • Ovens & Incubators
  • Vacuum Ovens
  • Ovens & Furnaces
  • Steam Autoclaves
  • Ethylene Oxide Autoclaves
  • Depyrogenation Tunnels & Ovens
  • Freeze Dryers
  • Washers
  • Disinfectors

Supply chain

  • Transport Qualification
  • Shipping Package Qualification (Isothermal Packaging)
  • Receiving / Preparation / Shipping Times
  • Cold Accumulator / Freezer Witness Use Procedures

Cleanrooms

  • HEPA Filter Integrity & Leakage Testing
  • Particle Counting
  • Decontamination Kinetics
  • Measurement of Air Velocities & Flow Rates
  • Microbiological Readings (Surface & Air)
  • Temperature & Relative Humidity Measurements
  • Noise & Light Measurements
  • Airflow Diagram
  • Microbiological Analysis
  • Tests on Compressed Air Networks (Particulate, Microbiological, Dew Points…)

Equipment qualification

  • Laminar Flow Cabinets
  • Microbiological Safety
  • Fume Extraction Cabinets
  • Suction Cabinets
  • Isolators
  • Sterilizer (Steam & Ethylene Oxide)
  • Freeze Dryer
  • Pasteurizer
  • Cooking Oven
  • Depyrogenation Tunnel
  • Muffle Oven
  • Washer-Disinfector
  • Microbiological Safety Station (MSS)

Our validation accreditations and standards

Client Results

8

of top 10 life science clients served

30

years experience in validation and qualification

600

GxP, FDA, ISO / IEC,Pharmacopeia experts

Services

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