Have confidence in your equipment performance and compliance

Qualification

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OverviewWhat we doOur ServicesAccreditationsClient resultsrelated services
Overview

When people’s lives are on the line, even the slightest error can prove catastrophic. You need to be able to rely on the precision of your equipment and the safety of your environments to ensure that you consistently produce high-quality products.

What we do

  • Climatic chambers
  • Refrigerators
  • Freezers and Ultra freezers
  • Refrigeration chambers
  • Ovens and incubators
  • Vacuum ovens
  • Ovens and furnaces
  • Steam autoclaves
  • Ethylene oxide autoclaves
  • Depyrogenation tunnels and ovens
  • Freeze dryers
  • Washers
  • Disinfectors
  • Transport qualification
  • Shipping package qualification (isothermal packaging)
  • Receiving/Preparation/Shipping times
  • Cold accumulator / freezer witness use procedures
  • HEPA filter integrity and leakage testing
  • Particle counting
  • Decontamination kinetics
  • Measurement of air velocities and flow rates
  • Microbiological readings (surface and air)
  • Temperature and relative humidity measurements
  • Noise and light measurements
  • Airflow diagram
  • Microbiological analysis
  • Tests on compressed air networks (particulate, microbiological, dew points…)
  • Laminar flow cabinets
  • Microbiological safety
  • Fume extraction cabinets
  • Suction cabinets
  • Isolators
  • Sterilizer (steam and ethylene oxide)
  • Freeze dryer
  • Pasteurizer
  • Cooking oven
  • Depyrogenation tunnel
  • Muffle oven
  • Washer-disinfector
  • Microbiological Safety Station (MSS)

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

Supply chain

Cleanrooms

Equipment qualification

Our Services

At Trescal, we verify that all of your cleanrooms, operation theaters and equipment meet specifications and regulatory standards onsite. We provide documented evidence across all qualification steps from design to installation to operations to performance:

Installation Qualification (IQ)

The instrument, with all its components and documentation, is placed correctly and checked for performance according to the requirements.

Operational Qualification (OQ)

All the major parts of the instrument are tested to ensure they all perform correctly and are in sync with the entire system.

Performance Qualification (PQ)

The instrument is monitored over a period of time to check if it consistently delivers results within the required parameters.

Accreditations and Standards

Client results

8 of top 10 life science clients served
30 years of experience in validation and qualification
600 GxP, FDA, ISO / IEC, Pharmacopeia experts

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