• ICH Testing 
• Refrigerated Testing
• Photobiology
• Photostability
• Humidity Testing
• Single Setpoint Testing
• Validation
• Transformation

ICH Testing Chambers and Rooms

Stability Environments ICH testing rooms and Reach-in Chambers are built to meet the stringent conditions recommended by ICH for the pharmaceutical Industry to test the stability of the drugs and drug products that are produced. Long term, accelerated and intermediate testing, as well as photostability studies, Q1A, Q1B option 1 and option 2 can be carried out in a single enclosure at different times by selecting the parameters on the plc controller.

ICH Harmonised Tripartite Guideline - Stability Testing

 

Below are charts showing the range of conditions which are attainable using Stability Environments typical Environmetal Room and Reach-in Chamber designs. All conditions selected are controlled within the ICH guideline limits of ±2°C and ±5%RH. In reality, the control is much better than that.

Typical Performance Envelope for a walk-in Room :

Typical Performance Envelope for a reach-in Chamber:

                                             With Refrigeration                           No Refrigeration