Role of Stability Chamber
Stability chambers offer a controlled temperature and humidity to a particular sample. They are recommended for stability testing in packaging or Pharma. The other uses involve controlled storage and environmental testing.
In the pharmaceutical sector, stability testing offers evidence about how a particular drug’s quality will differ with time under different environmental conditions such as light exposure, humidity as well as temperature. The testing is done before a drug is launched in the market.
In order to test the drug’s quality under particular humidity and temperature, a batch of the drug is placed in the stability chamber which has given humidity and temperature for a particular period of time. Samples are checked from time to time for quality evaluation. The stability test takes place over a period of time varying from a week to half a year or even one year.
Another stability test to notice is photo-stability, or how the drug will function when exposed to light or UV with time. For such kind of test, the chambers meet specific guidelines and emit the light and UV required over time.
Adhere to ICH guidelines
The stability testing guidelines are drafted by the ICH (International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use and are assessed by regulatory bodies globally such as FDA, EC and Health Canada.
The guidelines are precise and need that the temperature of the stability chambers doesn’t fluctuate more than 2 or 3 degrees according to the condition. The stability chambers used for such testing should have low temperature and humidity deviations for assessment over long testing periods.
Effective stability chambers offer performance for long-term testing
You can get the samples tested in these chambers from one week to six months to a year and more depending on the kind of testing being done. If a chamber breaks down in the procedure, then the last loses potentially months of work and will need to re-start with their time line, causing delay for the drug to enter the market. Stability chambers used for stability testing in the medical sector should be long-lasting, reliable and offer long-run performance for rigorous testing.
Some exclusive features can make the labs feel secure while using a stability chamber. For instance, a high and low temperature alarm can warn the observers about the deviation of the temperature. Also, remote monitoring systems permit users to keep a track of the conditions inside the temperature, even when the observer is not present in the lab.
Other prospective uses
Often in rare cases, the pharmaceutical lab may use the stability chamber for other applications. For instance, due to their consistent temperature and humidity, they are a perfect storage for samples which requires to be kept under stable conditions.
The best stability chamber
Stability testing for the medical industry needs a major investment and hence selecting the right instrument is very important. Stability chambers for testing drugs for stability under different temperature, humidity, and light should be stable, performance oriented, reliable and abide by the ICH guidelines. Stability Chambers from OS World India fulfills these requirements and maintains consistent temperature with time all through the chamber. They adhere to the ICH guidelines and render results as per your needs.