Thermal Cycling gives an indication as to how a product will react to adverse conditions, usually encountered during transportation.
Adverse Conditions
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. 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)
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 requirements.
Can we help you?
Contact us to find out more about how we can help you with your Thermal Cycling/Freeze Thaw studies or call +353 51 355 977.
Join our live webinars
If you are reading this article, then you may also be interested in our new webinar series. Following feedback from clients, we have recently curated a series of webinars designed for those working in the pharmaceutical, medical device and life sciences sectors with responsibility for designing and managing stability studies. If would like to gain some key insights into stability study design see our upcoming webinar series.
Temperature Excursion and Cycling Studies webinar
Join us on Wednesday 21st October 2020 at 2pm for our webinar on Temperature Excursion and Cycling Studies.
Temperature excursions during shipment can cause the recall of drug product lots, leading to delays in supply and loss of revenue. Data from a well-conducted temperature excursion and/or cycling study can be used to justify such excursions. There is currently no harmonised guidance dealing with the impact of temperature excursions during distribution or the effect of freeze/thaw cycles on liquids and semi-solids. This webinar reviews best practice in these areas.
This webinar will cover:
- Overview of regulatory guidance
- Temperature excursion risks to physical and chemical product stability
- Evaluating possible excursions using supply chain knowledge
- Temperature excursion studies
- Thermal cycling studies
- Transportation control strategy
