In the event of an inadvertent temperature excursion the following data may be used:

The product is stable when exposed to 25°C for 15 days. The product can be returned to fridge with no change required to its shelf life.

Temperature cycling data shows the product is stable when exposed to three cycles of -20°C for 2 days and 25°C for 2 days then stored at refrigerated/ambient conditions throughout the end of the shelf life.

Lastly, the product is stable when exposed to -20°C for 2 days followed by 40°C for 2 days and then stored at refrigerated/ambient conditions throughout the end of the shelf life.