Stability Budget
Based on product-specific stability data, a stability budget describes the time and temperature exposure a product can tolerate outside its normal storage conditions. It is not a universal time allowance: temperature level, duration and previous exposure must be assessed together.
What information is needed?
- Product data: demonstrated limits for the specific product and its intended state, for example unopened or already prepared.
- Temperature history: the magnitude and duration of the excursion. Brief, severe warming is not automatically equivalent to longer, milder warming.
- Exposure history: previous exposure must be included according to the product-specific assessment method. Cooling the product again does not automatically reset the budget.
Is this the duration of the thermal packaging?
No. The demonstrated packaging duration describes how long a particular packout maintains the required temperature range under defined test conditions. The stability budget concerns the product’s tolerance of exposure.
Following a temperature excursion, stability data provide the basis for assessment by the responsible quality assurance team. An available budget does not permit blanket release and replaces neither suitable transport protection nor documentation of the excursion.
Related terms: Product Stability · Temperature Excursion