We use scientific methods to create a simulated environment to scientifically study the impact of external climate change on products. And then to get scientific opinions on product transportation, storage, use, etc., this is the product of environmental monitoring system. Now the authoritative expert of the environmental monitoring system we recommend is the drug test chamber stability test chamber.

　　Drug Test Chamber Stability Test Chamber

　　The drug test box stability test box simulates a relatively stable temperature, temperature and illuminance and other comprehensive natural environments according to the simulation, and completes the stability and invalidity judgment tests of drugs in a natural environment.

　　Applicable scope of drug test box stability test box

　　It is used by pharmaceutical companies for accelerated testing, long-term testing, high and low temperature testing and direct sunlight testing of raw materials, drugs and medicines. It is also used as a stability test for skin care products.

　　Key application fields of drug test chamber stability test chamber

　　Applicable to pharmaceutical companies or pharmaceutical scientific research institutions, chemical intermediates, and raw material drug manufacturers. Product quality inspection and quality control departments of cosmetics companies.

　　Implementation and Compliance

　　Implementation of the 2020 edition of the Chinese Pharmacopoeia drug stability test guidelines and relevant provisions of GB/T10586-2006 production and manufacturing

　　Accelerated test: 40℃±2.0℃/75%RH±5%RH, or 30℃±1.0℃/60%RH±5%RH for 180 days

　　Long-term test: 25℃±2.0℃/60%RH±5%RH, or/30℃±2.0℃/60%RH±5%RH for 365 days

　　Accelerated tests for pharmaceutical preparations packaged in semi-permeable containers, such as infusion bags made of high-density polystyrene, plastic ampoules, ophthalmic traditional Chinese medicine preparation containers, etc., must be tested at a temperature of 40°C±2°C/25%± 5%RH conditions to carry out the test

　　For professional continuous tests on pharmaceutical preparations packaged in semi-permeable containers, the test must be carried out at a temperature of 25°C±2°C/40%±5%RH or 30°C±2°C/35%±5%RH

　　Strong light direct exposure test: 4500±500LX10 days

　　Stability test conditions

　　In the ICH guidelines, GMP and FDA define regulations in terms of multi-functionality and performance documentation . Europe, Japan and the United States allow the development of a common stability test. The purpose of this test is to combine information content as a recommendation for the stability of raw materials or drugs. The ultimate goal is to confirm drug exposure within a specified period. Effectiveness under temperature, ambient humidity, sunlight exposure or comprehensive environment.

　　Storage conditions for long-term standby stability tests

　　Temperature: +25℃±2℃ Ambient humidity: 60±5%RH Duration: December

　　Storage Conditions for Accelerated Stability Testing

　　Temperature: +40℃±2℃ Ambient humidity: 75±5%RH Duration: June

　　Strong sunlight and direct sunlight conditions Light intensity: 4500±500LX