Validator ® 2000
Benchmark Thermal Validation System

Thermal validation verifies that a specified piece of equipment or storage facility does indeed create and maintain the temperatures for which it was designed, through a process called temperature mapping.

The Kaye Validator 2000 is the most widely-used instrument in such high-accuracy temperature analysis, and measures the temperature distribution of an entire critical environment within 0.3°C accuracy using customizable thermocouple temperature sensors. These thermocouple sensors are ideal for extreme temperature measurements from oven profiling to cryogenic freezing because of their wide range and quick response to temperature variations.

The Kaye Validator 2000 system can measure a number of different systems with a high level of accuracy, collecting data at rates varying from two seconds to twelve hours for an indefinite length of time. The Validator 2000 can also perform any necessary statistical calculations, recording and exporting data for further analysis and graphing. Each unit is calibrated using a high accuracy (< ± 0.025°C) temperature standard before and after each verification run, assuring high levels of precision in each study with confidence.

This process, referred to as temperature mapping or validation or performance qualification, is in most cases the final step in a three part qualification process. Installation, Operation and Performance qualification protocols are developed for controlled environments to establish proper operation of the controlled environment and supporting equipment.

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.

Raw data is never modified Protects data with internal memory if floppy disk fills up or printer runs out of paper Saves data with battery back-up for up to 30 minutes if system loses power Plug-in Sensor Modules minimize sensor handling and save calibration time Eliminates the need for quick disconnects on each input Stores calibration offsets, allowing the software to link module with a specific instrument. From storage to instrument, sensors are ready for immediate use.

Most importantly, the Validator 2000 features a report generator that enables the grouping of calculations into customized, easy-to-read reports. The system organizes the test data in a spreadsheet format, saving analysis time and speeding access to critical process data.

Flexibility to operate standalone or with PC during testing

• Calibrates sensors and runs qualification studies with or without a PC
• Provides easy-to-read data for up to 12 sensors per screen with menu-prompted displays
• Enhances viewing on PC screens such as trending of live data

More flexibility to setup your test

• Separates sensors in up to four groups, e.g., independent reports for distribution and
  penetration or for qualifying multiple chambers
• Headers and comments are unique for each group
• Sets conditions for automatic starting and stopping of exposure and qualification
• Calculates lethality using base temperature, Z and D values
• Provides condition of lethality calculation based on chamber pressure
• Includes interval min., max., avg., and standard deviation calculations

Save time analyzing data

• Generates new spreadsheet formatted reports for each group: easy to read
• Creates Summary report to view test results at a glance
• Simplifies tracking of validation data since all results of Setup, Calibration and
  Qualification are kept in a single protected file
• Prints reports individually or all at once
• Locates files quickly because they are saved by descriptive name, author and date
• Monitors critical events and generates messages
• Trends inputs and calculations on-line

No more hassles to document exceptions

• Eliminates need to circle exceptions, write comments by hand, or use spreadsheet
  software to recalculate data
• Documents a failed sensor, but user can exclude bad data from calculations
• Captures user comments as part of standard report