Products

Thermal validation system

Doctor barrier
The sterilization procedure is carried out in final containers or packages, and the sterilization of microorganisms after sterilization is quantitatively measured to reduce the number of microorganisms to 1/1 million or less of the sterility assurance level. Our “Doctor Barrier” system is a system that provides support from actual operations to the preparation of a report by textualizing the fact that it was a sterilization that could determine F0 by measuring the temprature with high accuracy and inferring SAL≦10-6.

Overview

The following measurements are performed fully automatically.
・PC automatically calculates the compensation factor of the temperature sensor using the calibration device and the standard temperature indicating system, and stores the result in PC.
Install the temperature sensor in the sterilization unit.
・PC collects the thermometer readings in the sterilization unit.
・PC automatically compensates for each Thermometer and records it as true temperature.
・Displays the true temperature-change measured by PC as a trend chart.
・Calculates and displays the sterilization constant F0FH from the true temperature-data measured by PC. (It is easier to grasp the progress of the sterilization process.)
Remove the temperature sensor from the sterilization unit.
・PC automatically performs a post-calibration of the temp. sensor.

Main specifications of the software

・Complies with FDA/21CFRPart11 of electronic records and certification
・Recorded data cannot be tampered with.
・Security Management
・F-value calculation function
・Audit trail management
・Trend display during measurement
・Fully automatic measurement

System Assembly Example

Please click here for inquiry about thermal validation system.

List of Validation

Field validation measurement service

Knowledge of Validation

About validation