Description
Main functions
The drug stability test walk-in room is specially used in the pharmaceutical industry to conduct drug stability investigation tests to determine the validity period of drugs. It meets the long-term, accelerated and intermediate tests in the National Pharmacopoeia, FDA, ICH and other relevant standards, and also meets the 40°C, 20%RH low-humidity test for special drugs such as large infusions. Drug stability test chambers are used for intensive research in the pharmaceutical industry, medicine, biotechnology industry and all related industries including life sciences. Requirements of GMP principle 25C/60%RH humidity long-term stability test conditions. In the accelerated test, the humidity of 40C/75%RH is tested for 6 months. It is the field of stability test system in the pharmaceutical industry. It mainly simulates the temperature, humidity and light test in the environmental climate.
1) Manufacturing execution standard (technical conditions): refer to GB/T 10586-2006 Technical Conditions of Damp Heat Test Chamber
2) Guiding principle: IEC 60068-3-5 Environmental test of electrical and electronic products - performance confirmation of temperature test chamber
3) GB 5226.1-2002/IEC 60204-1:2000 Safety of Machinery - Electrical and Mechanical Equipment - Part 1: General Specifications
4) Meet the ICH2003Q1A (2) guidelines and the GMP 2010 version of the Chinese Pharmacopoeia stability test conditions:
1. Accelerated test: 40C±2C/75%RH±5%RH2. Intermediate conditions: 30C±2C/65%RH±5%RH3. Long-term test: 25C±2C/60%RH±5%RH or 30C±2C/65%RH±5%RH
Complaint
