The Ministry of Health, Labor and Welfare has issued a regulation for manufacturing control and quality control of pharmaceuticals: “Verify that the structure, equipment, procedures, processes, and other manufacturing control and quality control methods of the manufacturing site will give the expected results, and document this.” has been established as a requirement for such permission.
Solution
Sterilizer Temperature Distribution Measurement System
- Thermocouple
- RTD
- JCSS thermal calibration service
- Validation
- Medical & Pharmaceutical
Features
We can provide high-precision systems for temperature validation measurements in autoclave and tunnel-drying sterilization processes, as well as on-site measurements.
Our validation system guarantees measurement accuracy of ±0.5°C or less, which is in compliance with FDA-cGMP, the quality control standard followed by European and US pharmaceutical companies, and is ahead of the global standard for validation work.