ESD Cleanroom & Test
The drug stability test chamber 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℃, 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 25℃/60%RH humidity long-term stability test conditions. In the accelerated test, the humidity of 40℃/75%RH is tested for 6 months. It is the field of stability test system in the pharmaceutical industry.
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: 40℃±2℃/75%RH±5%RH
2. Intermediate conditions: 30℃±2℃/65%RH±5%RH
3. Long-term test: 25℃±2℃/60%RH±5%RH or 30℃±2℃/65%RH±5%RH
Add: No.151 Houjie Road, Houjie
Town, Dongguan, Guangdong, China
Tel: +86 18666881028 WhatsApp：+86 18666881028
Inquiry Mail: wangdep@esd-conductive.com
or sales01@esd-conductive.com
Technical
Support:tech@esd-conductive.com