Temperature out of range: what to do

An alarm at night, “plus ten” in the refrigerator in the morning or a triggered indicator at receipt — at such a moment it is important not to miss a step. The wizard takes you through it in order: what to do immediately, how to quarantine, how to assess the goods, whom to notify — and builds the text of the excursion record.

The essentials in three lines

The order of actions is the same as on the temperature monitoring page, section “What to do in case of a deviation”.
Step	Why it matters
Save the logger or monitoring system data	without values and duration the excursion cannot be assessed or the record supported
Do not release the goods until decided	quarantine separates the affected batches from the rest of the stock
Assess using manufacturer data	only the manufacturer knows whether short excursions are acceptable — stability data

To stop it happening again you need the cause: an open door, a unit failure, a poorly placed sensor. If the cause is not found or excursions recur at the same point, that is a reason for re-mapping. A monitoring system with alarms tells you within minutes rather than in the morning.

Frequently asked questions

Can a medicine be sold after a temperature excursion?

Only after assessment by the authorised person based on the manufacturer's stability data. Until then the goods are quarantined and not released.

What if the excursion is found at receipt?

Do not take the goods into stock: note the transport excursion in the receiving documents, quarantine the shipment and notify the supplier in writing with the logger or indicator data.

What if vaccines may have frozen?

For adsorbed vaccines with an aluminium adjuvant SanPiN 3.3686-21 describes the shake test; a damaged vaccine must be written off. See the vaccine cold chain page.