Temperature Standards for Cold Chain Logistics

Written by Michael Steedman | Aug 10, 2022 3:19:01 PM

This information has been collated from various online sources which have been acknowledged at the end of the short article.

Hopefully it will be useful as a reference resource.

Temperature-controlled transport is generally categorized into the following temperature ranges:

(-28 °C to -30 °C) Deep freeze — seafood, meat exports.
(-16 °C to -20 °C) Frozen — meat, certain types of produce.
(2 °C to 4 °C) Chill — fruit & vegetables, fresh meat, certain dairy products.
(2 °C to 8 °C) Pharma — medicines, vaccines.
(12 °C to 14 °C) Cool-chain — fresh produce, processed food, over-the-counter drugs.

CRT: Controlled Room Temperature

What are the regulatory Definitions for "Ambient", "Room Temperature" and "Cold Chain"?

Varying definitions are as follows:

The European Pharmacopoeia (Pharm.Eur.)

Deep-freeze: below -15°C;
Refrigerator: 2°C to 8°C;
Cold or cool: 8°C to 15°C;
Room temperature: 15°C to 25°C.

There are also some definitions in the WHO Guidance:

Store frozen: transported within a cold chain and stored at -20°C (4°F).
Store at 2°-8°C (36°-46°F): for heat sensitive products that must not be frozen.
Cool: Store between 8°-15°C (45°-59°F).
Room temperature: Store at 15°-25°C (59°-77°F).
Ambient temperature: Store at the surrounding temperature. This term is not widely used due to significant variation in ambient temperatures. It means "room temperature" or normal storage conditions, which means storage in a dry, clean, well ventilated area at room temperatures between 15° to 25°C (59°-77°F) or up to 30°C, depending on climatic conditions.

The table below shows the variation between different organisations.

	European Pharmacopoeia	WHO	US Pharmacopoeia	Japan Pharmacopoeia
Frozen/Deep freeze	›-15°C	-20°C	-	-
Refrigerator	2°C - 8°C	-	-	-
Cold	8°C - 15°C	2°C - 8°C	›-8°C	1°C - 15°C
Cool	8°C - 15°C	8°C - 15°C	8°C - 15°C	-
Room temperature	15°C - 25°C	15°C - 25°C	Temperature prevailing in a work area	1°C - 30°C
Controlled room temperature	-	-	20°C - 25°C. Excursions between 15°C and 30°C are allowed	-
Ambient temperature	-	15°C - 25°C or 30°C depending on climatic conditions	-	-

The term “cold chain” for uninterrupted refrigeration has given way to “temperature-controlled.” The spectrum ranges from ambient, or controlled room temperature (20°C to 25°C), to refrigerated (2°C to 8°C), to cryogenic (below 0°C to as low as −150°C). Pharmaceutical & Medical Packaging News surveyed supply chain experts in 2015 and arrived at these findings: Of temperature-sensitive products shipped, 51% were ambient, 31% were refrigerated, 17% were frozen, and 32% should not be allowed to freeze.

Sources:

https://www.gmp-compliance.org/gmp-news/what-are-the-regulatory-definitions-for-ambient-room-temperature-and-cold-chain

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5821242/

https://transportgeography.org/contents/applications/cold-chain-logistics/temperature-standards-cold-chain/

Stabilising temperatures in transit

Here are some products that will help maintain stable temperatures while goods are travelling.

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