About validation

Validation is defined in the Ministry’s Ordinance on Pharmaceutical and Medical Equipment GMP(Good Manufacturing Practice as “Validation is to verify and document the expected results of the manufacturing facilities and procedures, processes, and other manufacturing control and quality-control methods at the manufacturing site.” It is necessary to clarify the connection with the standard instrument information in this documented content, and one of the methods is pre-calibration and post-calibration.

The temperature validation work is as follows.

１．Heat distribution test
Calibrate the working sensor with a reference standard and use this sensor to measure the heat distribution of the actual work condition to evaluate the thermal stability condition. For example, EN554 specifies that a number of 12 sensors per ｍ３ is required.
However, there is no detailed specification for the work procedure, and (1) it is necessary to measure again each time the condition of temperature load changes. (2)Repeated tests are conducted to confirm the repeatability of the measurement results. This is the specified level.
After understanding these requirements, determine the work procedure and execute the test. Determine the judgment criteria such as that the measurement accuracy is ± ** °C and the measurement is continuously over ** minutes, and that the overshoot is ℃ or less.

２．Heat penetration study
Imagine a beaker containing liquid that has been inserted into a temperature chamber. The temperature of the temperature chamber reaches the specified temperature. After a certain period of time, the temperature of the entire area of the chamber will have reached the expected temperature. However, the liquid temperature of the built-in beaker and the deepest part of it do not reach the expected temperature immediately. The heat permeation test is a test to confirm that the expected temperature is reached even in places where such temperature is difficult to penetrate.

These temperature measurements are performed using a working sensor traced to the national standard “JCSS logo-bearing sensor.”