Temperature Excursions: Records, Limits and Decisions
A temperature excursion is an exposure outside the documented conditions for the material. If a parcel feels warm or a storage alarm sounds, first establish which condition applied and what was actually measured. The answer determines which lot, containers and time interval need assessment.
Capture the event before interpreting it
| Field | What to record |
|---|---|
| Material | Product, form, lot and affected containers |
| Required condition | Instruction and document version |
| Event interval | Known start/end times, or the limits of what is known |
| Temperature evidence | Logger file, measurement location and device reference if available |
| Other observations | Packaging condition, damage or delay |
| Information gaps | Missing interval, absent logger or uncertain location |
| Immediate status | How affected stock is identified pending assessment |
Keep the original logger file and the storage instruction in force at the time. Record the device location, units, time zone and any gap in readings. If someone later corrects a timestamp, retain both the original entry and the reason for the correction.
For a delivery, link the event to the receiving and inspection record. Check the UK delivery arrangements for the particular order to identify any agreed monitoring or transport conditions.
A logger alarm and a warm parcel need different records
In a fictional shipment, the box logger first read above the specified upper limit at 10:15 and was still above it at 10:45. Those readings are 30 minutes apart. Record the sampling interval and adjacent readings before estimating when the limit was crossed or when the excursion ended. The device measured conditions at its location in the box.
In a second example, a parcel arrives warm to the touch and has no logger. Record the arrival time, the condition of the packaging and the affected container IDs. The peak temperature and the exposure duration remain unknown.
Neither record sets an allowable time outside storage. To make that decision, compare the evidence with the actual material, presentation, storage instruction and stability information.
Request a decision tied to the material
Identify the affected material under your laboratory’s hold procedure. Send delivery support the product, lot, affected containers and observations. Ask which evidence covers this excursion and who will assess it.
The storage and stability guide explains how to read a supported period. A pre-shipment purity result may describe the sampled material before dispatch. It cannot answer what happened to a container during a later exposure.
Close the record transparently
Record the decision, date, responsible person, evidence and any unresolved interval. Keep the entry with the lot even if the material is released. Use the research guides for related records on storage, preparation and sample history.
Other records for this assessment
| Resource | Why open it |
|---|---|
| Storage Conditions for Lyophilised Research Materials | Record storage history for the dry presentation. |
| Storage, Packaging and UK Fulfilment | Separate stockholding, dispatch arrangements and transit evidence. |
| Batch Release, Quarantine and Rejection | Separate test results from a documented batch-release decision. |
| Storage & Stability | Find the storage, stability or excursion record you need. |