Product Description

CDR E. CHRYSSAGIS provides pharmaceutical stability chambers and rooms that have been designed and validated for pharmaceutical stability storage tests and BioTech stability tests according to Q1A ICH guidelines. The assessment of drug substance stability is a vital and essential component of the development of pharmaceutical products. Stability testing is capable of providing information on how environmental factors such as temperature, humidity and light affect the quality of a drug substance or drug product over a period of time. To meet the quality criteria of the stability tests, the physical, chemical and microbiological characteristics of pharmaceutical substances are tested after exposure to specific conditions over a defined period. To that end, the following climate conditions were established for long-term testing, accelerated testing, and testing at intermediate conditions according to the ICH Guideline Q1A.