Cold-chain break: how long is too long, and what to do

How long: what the texts say, and what decides

Regulation (EC) No 852/2004, Annex II, Chapter IX, says the cold chain is not to be interrupted, then admits limited periods outside temperature control for the practicalities of handling, provided that no risk to health results. It does not say how long: the operator has to justify it, product by product, in the food safety plan. For quick-frozen food in transport and storage, Regulation (EC) No 37/2005 requires air-temperature recording, precisely so that this justification rests on a measurement.

Two facts decide, then, and neither can be guessed: how far the temperature rose, and for how long. A full cabinet whose door stayed shut and an empty one whose door stayed open did not have the same night. Without a record, the duration is counted from the last compliant reading, often the previous evening, and the cautious decision is to discard. With one, it is counted from the minute the curve left the range.

Fridge or cold room down: the five moves of the first hour

1. 1

   Keep the door shut

   A full, closed enclosure warms slowly; every opening to check speeds up what you fear. A thermometer inside, or the logger, tells you what is happening without opening.

2. 2

   Establish the start time

   The time of discovery is not the time of the failure. Without a record, the duration is counted cautiously from the last compliant reading; with one, the curve gives the minute the drift began, often much later.

3. 3

   Move the goods, most sensitive first

   To an enclosure that holds their range: minced meat and preparations before the foods that tolerate +8 °C; frozen goods to a freezer, never to a fridge. What cannot be moved stays behind a closed door.

4. 4

   Call the technician, curve in hand

   An outright failure, a door left open, a defrost that never recovered and a fouled condenser are not repaired the same way. The temperature history steers the diagnosis before the visit.

5. 5

   Decide batch by batch, and write it down

   Temperature reached, duration, nature of the product: three facts, one decision per batch, noted with the time on the corrective-action sheet. That document, not the absence of incidents, is what an inspection reads.

A vaccine out of the fridge: what the pharmacy can decide, and what it must record

Vaccines and temperature-sensitive medicines are kept between +2 and +8 °C, a narrower range than food refrigeration and without its tolerance. How long a vaccine can stand being out of it depends on the vaccine: each manufacturer publishes the out-of-range stability data of its product, carried in its notice, and that source, with the national medicines agency, answers, not this page. What the pharmacy must do, however, does not depend on the product: quarantine the doses without discarding them, record the maximum temperature reached and the exact duration of the exposure, then ask the manufacturer or the wholesaler with those two figures. A logger in the pharmacy fridge supplies them to the minute; a morning and evening reading gives neither, and the manufacturer will answer cautiously.

Before the breakdown: four signals the curve shows and the thermometer misses

Most refrigeration failures start with a slow drift, not a sudden stop. Each component of a refrigeration unit ages in its own way and leaves a signature in the temperature over the days. A morning and evening reading sees a value; a continuous curve sees a trend. The monitoring reveals symptoms and steers the technician; it does not replace the diagnosis, and a sudden mechanical failure remains possible.