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.
Testing at intermediate conditions is carried out in the event there are deviations between the first two forms of testing.
• Long-term testing at +25?C / 60% RH or +30?C / 65% RH
• Accelerated testing at +40?C / 75% RH
• Intermediate testing at +30?C / 65% RH
Semi permeable packaging or stipulated substances are tested in the following conditions:
• Long-term testing at +25?C / 40% RH
• Accelerated testing at +40?C / <25% RH
The working range of CDR ENVIMED Series not only meets
the requirements of the Q1A & Q1B ICH Guideline but their performance allows the testing of additional conditions outside
Control of temperature within +/- 0,5-0,7?C and humidity within +/-3% is achieved by the use of high precision sensors in conjunction with a specially designed control unit.