Temperature Excursion

A temperature excursion is an event in which a time and temperature-sensitive pharmaceutical product is exposed to temperatures outside the range(s) prescribed for storage and/or transport. Temperature excursions can occur at any point in the air cargo cold chain, from origin handling through final delivery, and require immediate investigation and risk assessment. Tarmac exposure during loading and unloading accounts for majority of excursions, with extended time in uncontrolled outdoor conditions during hot or cold weather causing most documented deviations. The IATA Temperature Control Regulations (TCR) addresses temperature management issues identified by the industry, requiring carriers and handlers to implement corrective and preventive actions when excursions occur.

A Lufthansa Cargo shipment with AWB number 020-87654321 carrying insulin from Frankfurt (FRA) to Miami (MIA) experiences a temperature excursion when tarmac delays expose the cargo to 35°C ambient temperature for 3 hours, exceeding the required 2-8°C range. An Emirates SkyCargo pharmaceutical shipment AWB 176-55443322 from Dubai (DXB) to London Heathrow (LHR) triggers an excursion alert when customs clearance delays extend ground time to 18 hours, causing internal container temperatures to drift outside the validated 15-25°C controlled room temperature range despite proper passive packaging.

• temp excursion
• cold chain break
• temperature deviation
• temperature breach
• excursion event

What temperature ranges trigger a temperature excursion for pharmaceutical air cargo?

Vaccines that require temperature-controlled shipping must be kept between 2℃–8℃ or -20°C in order to maintain the effectiveness of their active ingredients. Air cargo supports 2–8°C (refrigerated), 15–25°C (controlled room temperature), 2–25°C extended range, and frozen ≤-18°C. Any exposure outside these manufacturer-specified ranges constitutes an excursion requiring documentation and risk assessment per IATA TCR requirements.

How long do pharmaceutical products need to be quarantined after a temperature excursion?

Companies should immediately quarantine the product, notify QA, document the event, perform a stability assessment, and decide whether to release or reject the batch. A decision needs to be made to release or quarantine the product based on complete measurement record from a calibrated sensor and stability budget assessment criteria with clear conditions of temperature zones/limits and allowed times. Quarantine duration depends on stability data analysis and may include additional criteria like number of allowed excursions or freeze-thaw cycles.