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The Validator 2000 is a standalone thermal validation solution specifically designed to conform with new FDA data protection guidelines (21 CFR Part 11) and meet international and European cGMP requirements for inspection of pharmaceutical, biotechnology and medical device (EN285, EN554) manufacturing. The Validator 2000 simplifies the entire validation process by reducing setup time and minimizing sensor handling, automating sensor calibration, neatly organizing study data and generating regulatory required reports.
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Meets FDA guidelines for protecting electronic data (21 CFR Part 11)
- Prevents unauthorized access via user ID and password for critical operations
- Creates secure results using files that cannot be used if tampered with
- Creates printed or spreadsheet reports from a single protected file.
- Creates comprehensive audit trail of all actions affecting user data.
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- Accepts up to 36 inputs in any combination of thermocouple, voltage or current inputs
- Provides total system accuracy of
0.28°C with improved noise immunity
- Meets European requirements for fast data storage of one sample per second
- Supported by fully validated hardware, software and firmware documentation
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The LTR Series temperature references are dry wells specifically designed to fully automate sensor calibration when used with GE Kaye validation software and traceable temperature standards.
GE Kaye dry wells employ unique inserts which minimize cooling of the thermocouple tips due to heat conduction providing an uncertainty of merely 0.1°C. Without proper inserts, for example, transfer uncertainty in excess of 0.5°C can occur with 22 gage, type T thermocouples.
The LTR series features fast heat up and cool down, a capacity to hold from 18 to 24 thermocouples and require no messy oils.
Calibrating sensors in the environment where they will be used provide the highest degree of accuracy as system temperature coefficient errors are eliminated. The references are lightweight and rugged so you can calibrate sensors almost anywhere. |
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These transmitters are microprocessor based instruments for the
measurement of relative humidity and temperature; from these variables they can calculate dew point temperature, absolute humidity, mixing ratio, wet bulb temperature and enthalpy. The transmitters have two analogue outputs and they can be connected to the GE KayeValidator 2000 for data logging.
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