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Calibrations/Calibrators


PyroDisk-PB Calibrator for the Calibration of Microplate Photometers and Incubators

Introduction

Temperature dependent reactions, such as LAL-endotoxin kinetics require temperature control and compliance to temperature specification. Meaningful calibration verification is necessary at suitable intervals to ensure that temperature accuracy & temperature variability specifications have been met.

PyroDisk-PB calibration system utilizes a high performance Self-powered temperature calibrator and integrated software. Key modules of the calibration system:

  • NIST referenced calibration of each temperature sensor at multiple points
  • Certificate of Calibration with uncertainty of measurement data
  • 21 CFR Part 11 compliant PyroDisk-PB software
  • 21 CFR Part 11 Configuration Management
  • SQL database
  • EQUALTM Decision Support Subsystem with SQC capability
  • PyroLogger-PB, a high performance 5-channel Self-powered temperature measuring device having the following characteristics:
    • Temperature range 0°C to 85°C (optionally: 0 - 125°C)
    • Temperature resolution 0.0625°C
    • Temperature accuracy < 0.1°C
    • Sensor-to-sensor reproducibility < 0.1°C
    • Intra (within) sensor reproducibility < 0.1°C
    • Sampling rates 10 sec to several hours
    • Life expectancy of the internal battery is up to 10 years
    • No separate charger is required (power is drawn from the PC during connection)
    • USB, serial, or parallel interface
  • 3 years warranty

OPTIONS

  • DQ-IQ-OQ-PQ verification
  • 21 CFR Part 11 verification
  • Heat capacity correction module
Key Benefits to the User
  • 21 CFR Part 11 compliant system
  • Both temperature accuracy & variability of the incubator can be determined
  • No separate charger is required
  • USB, serial, and parallel interfaces are available
  • Simple to learn graphical user interface
  • Calibration scheduling can be determined relative to Calibration Needs Analysis
  • On-line competency training of the calibration
  • OOS, OOT, & CAPA investigations support
  • Optional heat capacity correction
  • SQC of the calibrations
  • Highest Return-On-Investment









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