Temperature excursions in the pharmaceutical cold chain
A temperature excursion is a deviation outside a product’s specified storage or transport temperature limits. It can involve either excessive heat or excessive cooling. The relevant criteria are the specific product requirements and the recorded temperature history at the relevant measurement location.
What information is needed when an excursion occurs?
- The temperature reached, duration and timing, linked to the affected shipment and batch.
- Measurement information: sensor position, device operation and, where relevant, measurement uncertainty.
- The transport sequence, indications of the cause and suitable product data, including relevant previous exposure.
Must the goods automatically be discarded?
An excursion does not automatically demonstrate product damage. The affected goods are handled under the defined quality procedure and, where appropriate, quarantined pending a decision. The responsible quality assurance team assesses their suitability for use on the basis of the data; a stability budget may support this assessment. An acceptable average temperature alone does not cancel out a critical individual exposure. Causes and necessary actions are documented.
Related terms: Product stability · Temperature monitoring / data loggers