Eurofins BioPharma Product Testing Kyoto offers state-of-the-art GMP storage services. Our storage conditions meet ICH guidelines and can be customized for any project with the ability to provide the desired temperature and humidity conditions. Stability studies can be performed under various storage conditions, with temperatures ranging from -80°C to 80°C and RH ranging from 20% to 92%.
How can Eurofins BioPharma Product Testing Kyoto provide GMP storage and meet ICH guidelines?
With a variety of set points, each chamber operates independently with separate temperature and humidity controls. In an emergency, the forced ventilation system operates to protect samples from extraordinarily high humidity. Emergency generators are also installed on the roof to respond to power outages in emergency situations.
Our sample storage facility with a space more than 2,400 square feet is maintained in a secured area, which is continuously monitored by a validated monitoring system, 24 hours 365 days. If the deviation (each storage condition ranges out over a stipulated temperature and humidity range) remains for 5 min, the alarm will sound and the person in charge of test sample management will be called up. The data are backed up monthly. Moreover, when the samples are stored in the facilities, the person in charge will input all the detailed information regarding the sample retrieval date and the location of samples into the dedicated software system.