A stability chamber works on the rule to maintain temperature and relative humidity of the chamber with the help of water stored and thermostat in the chamber. According to the law of Physics, the air in the chamber will maintain higher humidity because of the high temperatures in the chamber. The reason behind it is that high temperatures enhance the air capacity to maintain high humidity with specific conditions. This is how the stability chamber works.
Stability chambers are manufactured to create artificially environmental conditions for the medicines which need to be exposed to different environmental conditions. Sometimes they are used to increase the exposure effects to atmospheric conditions which may be adverse in any area where pharmaceutical companies are storing the medicine.
For instance, the medicines or products produced in the United States may not be suitable for Indian environmental conditions. Hence it is very important to check the stability of the product by testing it in the stability chamber according to the Indian environmental conditions created in the chamber in a United States laboratory. It permits the pharmaceutical company to evaluate the effects of the different environmental conditions on the product in a particular time period.
In the food industry or pharmaceutical sector, stability testing allows you to get evidence of how the quality of a drug will differ with time under different environmental conditions which comprises of temperature, humidity and exposure to light. The testing is done before a product enters the market.
In order to test the efficacy, quality and maintenance of the drug under particular temperatures and humidities, a group of drugs is placed in the chamber with controlled temperature and humidity for a specific time period. Samples are periodically analyzed for quality studying. As stability testing takes place over different time spans rangingfrom some days to weeks to months or a year, the chamber should be reliable and effective.
Compliance to the ICH guidelines for uniform performance
The rules for stability testing have been already mention by the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) and are followed by the companies globally including FDA, EC and Health Canada.
The rules are pretty specific and need that the temperature in the chamber doesn’t fluctuate more than 2 or 3 degree as per the condition and the humidity doesn’t deviate by anything more than 5%. Hence, the stability chamber used for such testing should have low temperature and humidity variations over long testing periods.
An all-round performing stability chamber
Stability testing for the medical industry needs a lot of time and money investment. Hence it is very important to choose the right device. Stability chambers used to test drugs should have temperature variation, humidity range and light exposure to get reliable and effective results. Moreover, they should adhere to ICH guidelines. Stability Chambers from OS World India fulfill all your requirements and help you get consistent temperature and humidity over time as per your needs.