Thermal Validation


Thermal Validation

Micron is a leading validation service and testing provider to the pharmaceutical, healthcare industries, Hospitals and Automobiles industry.

We specialise in the validation of internal standard as per-

  • WHO TRS 961
  • WHO TRS 937
  • ISO/IEC: 60068

To validate something is to prove its accuracy, and temperature validation is no different. When monitoring the temperature of an environment, the proof is just as important as the result. From food and beverages to pharmaceutical applications, making sure the results gained from temperature mapping equipment are valid and precise is vital.

Thermal validation is the process of testing and proving that temperature-sensitive products or environments are being monitored and recorded correctly.

How does it work?

Our Thermal validation system uses high-quality temperature mapping equipment such as data loggers. These tools are placed in environments of extreme temperatures and pressure and are able to feedback valuable data.

The collected data is then processed and analysed using comprehensive data-logging software. Industry-standard time temperature reports are then arranged and

We are expert in the Qualification of the following equipment and systems.

  • Autoclave / Sterilizer Qualification
  • Cold Rooms, Warehouse and Room Mapping
  • Dehydrogenation Ovens Qualification
  • Lyophilizes Qualification
  • dehydrogenation Tunnels
  • BOD, Deep Freezers / Walk in Freezers
  • Photo stability Chamber Qualification
  • Steam-in-Place Qualification
  • Incubators
  • Stability Cabinets
  • Washer Disinfectors
  • CIP Systems
  • Dry Heat Ovens
  • Furnace

Our priority is to serve quality service is fulfilling validation, regulatory and compliance serve from standalone automated equipment to start up, commissioning and validation of new services.

Result you can count & report you can trust

Micron will provide a clear, comprehensive validation report, confirming that your systems are compliant with your standard operating procedures. Our validation reports contain all the data necessary for you to have confidence in the operation of your equipment; each one is written to comply with your quality assurances practices, as well as cGMP and FDA requirements.

Micron can perform accurate qualifications that meet or beat your targeted time frame. Our wide variety of data logging system options helps us choose a custom solution to meet your unique protocol requirements.

Wireless High-Performance Data Loggers

  • Real-time environmental chamber monitoring facility with high accuracy
  • Range from -20°C to 70°C & 0 to 100% RH
  • Easily fits in all chambers, vessels, containers, and appliances
  • 21CFR Part 11 compliant software for reporting and analysis
  • NABL- traceable calibrations certificate to meet regulatory requirements

Wired High-Performance Data Loggers

  • Ultra-premium Type T PTFP coated wires for projects ranging from -200°C
  • to 200°C
  • Ultra-premium Type T Kapton coated wires for dry projects up to 350°C
  • Specialty thermocouples for high temperature projects
  • Custom thermocouple feed- through optimize mapping results
  • NIST - traceable calibrations certificate to meet regulatory requirements

Protocol Development and Consultation

Micron can prepare Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) protocols for you or we can execute your own protocols. We apply our experience with instrumentation and controls recommending and implementing essential modifications to bring your equipment into compliance.