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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