Stability Chamber

Stability chambers are ideal for testing storage, shelf life, packaging and stability. Stability chambers are available in temperature only or with temperature and humidity. Sizes range from reach-in to walk-in and most chambers feature a temperature range of -20° C to 60° C and an optional humidity range from 10% to 95% RH.

Stress testing is likely to be carried out on a single batch of the drug substance. It should include the effect of temperatures in 10° C increments (50° C, 60° C, etc.). Increments may be greater for accelerated testing. Stress testing for humidity typically is performed at 75% RH or greater (where appropriate).

Other tests can include effects of oxidation and photolysis. Stress testing of the drug substance can help identify the likely degradation products, which can in turn help establish the degradation pathways and the intrinsic stability of the molecule. It can also validate the stability indicating power of the analytical procedures used. The nature of the stress testing will depend on the individual drug substance and the type of drug product involved.