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PyroDisk-XT Calibrator for the Calibration of PCRs & Thermal-Cyclers

Introduction

Temperature is the source of energy in PCR reactions. Suitable temperature specification is the key to reliable results. Meaningful calibration is necessary to ensure that temperature specifications have been met.

The byproduct of inaccurate and/or poorly reproducible temperature cycling can result in low yields, unwanted artifacts, and overall unreliable results. Temperature calibration and calibration verification at suitable intervals of PCRs & thermal-cyclers are necessary.

PyroDisk-XT calibration system utilizes a high performance 24 channel Self-powered temperature data-logger, integrated software, and SOP procedures. Any configuration of PCRs and thermal-cyclers can be calibrated. 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-XT software
  • 21 CFR Part 11 Configuration Management
  • SQL database
  • EQUALTM Decision Support Subsystem with SQC & SPC models, such as:
    • Control Chart for calibration Performance Qualification
    • Pareto Diagram for worst-case-analysis
    • Correlation analysis capability relative to PCR models and serial numbers
    • Ad hoc query capability, and
    • Data mining capability
  • PyroLogger-XT, a high performance 24-channel Self-powered temperature measuring device having the following characteristics:
    • Temperature range -50 °C to 150 °C
    • Temperature resolution 0.001 (internal) / 0.002 (ext)
    • Temperature accuracy < ±0.05 °C
    • Sensor-to-sensor reproducibility < ±0.02 °C
    • Intra (within) sensor reproducibility < ±0.02 °C
    • Sampling rates 100 msec / sensor
    • Li-ion rechargeable battery (life expectancy is about 10 years)
    • 3 years warranty

Using EQUAL Decision Support Sub-system of PyroDisk-XT, Performance Qualification of the calibration can be evaluated and the PCR can be optimized relative to:

  • Product yield and purity
  • PCR temperature map & temperature settings
  • Preventative Maintenance
  • Compliance Management
  • Calibration scheduling relative to Calibration Needs Analysis
  • Highest Return-On-Investment.

Each calibration record contains:

  • Certificate of Calibration ID
  • Calibration Reference ID
  • Dates of calibration with QC/QA approval
  • Calibration SOP
  • Results of calibration relative to specification, including
    • Temperature accuracy & temperature uniformity relative to set temperature protocols
    • Overshoot & undershoot data
    • Ramping rates
    • Steady state analysis
  • Statistical evaluation, including uncertainty of measurement data
  • Next date of scheduled calibration

OPTIONS

  • DQ-IQ-OQ-PQ verification
  • 21 CFR Part 11 verification
Key Benefits to the User
  • 21 CFR Part 11 compliance - the calibrations are performed with a compliant system
  • Product yield and purity can be correlated to temperature accuracy & uniformity
  • PCR temperature map & temperature settings are evaluated between calibrations
  • Reliable Preventative Maintenance Scheduling can be defined
  • Improved Compliance Management
  • Calibration scheduling relative to Calibration Needs Analysis
  • On-line competency training of the calibration
  • OOS, OOT, & CAPA investigations support
  • Highest Return-On-Investment









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