Products

Field validation measurement service

Sterilization validation such as autoclaving and tunnel drying
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. For example, we measure F0 with a high degree of accuracy and provide support from the actual operation to the preparation of a report based on a sentence stating that it was a sterilization method capable of estimating SAL≦10-6.

Overview

In each validation of the development, verification, and operation of product manufacturing, we support the actual work of measuring the temperatures and pressures that accompany the actual operation. The measurement data is a text that verifies that the plant’s structure and equipment as well as the procedures, processes and other methods of manufacturing control and quality control give the expected results. The conformity judgement of the structure and equipment is carried out according to the predetermined tolerance.

Doctor Barrier, a thermal validation system that we sell, is used for measurement.
Mapping of frozen storage containers, freezers, etc. is also performed.

List of Validation

Knowledge of Validation

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