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Temperature Mapping & Thermal Validation

At CALITECH, we specialize in comprehensive Temperature and Relative Humidity Mapping services, performed under our NABL accreditation. Our detailed reports provide critical insights into the thermal environment, featuring diagrams that illustrate sensor locations and capturing both minimum and maximum temperatures across various points. The graphical representation of temperature versus time, along with analyses of hot and cold spots, standard deviation, and Mean Kinetic Temperature (MKT), ensures a thorough understanding of temperature variations and their impact on your storage conditions.

For warehouse and cold room environments, we conduct rigorous temperature and humidity assessments. This includes validating the effectiveness of storage conditions and ensuring compliance with industry standards. Our meticulous approach guarantees that your storage areas meet the required specifications, maintaining optimal conditions for sensitive materials.

In addition to temperature mapping, CALITECH offers advanced equipment validation services in line with the latest 21 CFR Part 11 requirements. We use state-of-the-art data loggers and software for FO value calculations, adhering to EN 285/HTM 2010 guidelines. Our validation processes encompass a range of equipment, including autoclaves, dry heat sterilizers, ETO sterilizers, and more. Our reports provide detailed analysis of empty chamber performance, heat distribution, and penetration studies, complete with graphical representations and time-lag assessments to ensure precise and reliable validation.

Temperature Mapping

  • Temperature & Relative Humidity Mapping under NABL Scope
  • Report includes diagrams indicating sensor locations
  • Minimum & Maximum Temperature recorded at all locations
  • Graphical Representation of Temperature vs. Time
  • Analysis of Hot & Cold Spots
  • Calculation of Standard Deviation and Mean Kinetic Temperature (MKT)

Thermal Validation

  • Validation with Latest 21 CFR Part 11 Complying Data Logger
  • Validation performed as per EN 285/HTM 2010 Guidelines
  • Reports include Empty Chamber and Heat Distribution studies
  • Assessment of Penetration Study with and without Load
  • Reporting formats include FO, Fd, Fh, Minimum & Maximum Temperature
  • Graphical Representation of Temperature vs. Time
  • Analysis of Hot & Cold Spots and Lag Time