Thermal Cycling gives an indication as to how a product will react to adverse conditions, usually encountered during transportation
Temperature sensitive medicinal products should be transported in a manner which ensures product quality is not adversely affected. Transportation of product typically takes place within a commercial environment. Factors such as traffic events and unforeseen weather conditions can delay shipments and have a deleterious effect on the product.
Thermal Cycling involves rotating samples between sub zero and ambient conditions
The range encountered during transportation may differ from that which is specified for long term storage, ascertained from stability studies. To understand the effect these excursions may have on a product, Thermal Cycling studies are completed. Also known as freeze thaw studies, they are used to evaluate the potential effects of temperature deviations that may occur during the transport process. The storage conditions and the lengths of studies chosen should be sufficient to cover storage, shipment and subsequent use (ICH Q1 A 2.1.7)
An example of a study, would follow the following process:
Q1 Scientific can customise Thermal Cycling/Freeze Thaw studies to clients specific requirement.