Thermal Cycling gives an indication as to how a product will react to adverse conditions, usually encountered during transportation. 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)
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.
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.
Thermal Cycling Process
An example of a study, would follow the following process:
- The samples in our example have a recommended storage condition of 20°C to 25°C
- Samples are placed on stability storage at -20°C for 48 hours.
- Samples are then transferred to 40°C / 75%rH for 48 hours.
- Procedure is repeated for a total of 3 cycles.
Q1 Scientific can customise Thermal Cycling/Freeze Thaw studies to clients specific requirement.