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.ncbi.nlm.nih.gov/pmc/articles/PMC5821242/
Stabilising temperatures in transit
Here are some products that will help maintain stable temperatures while goods are travelling.
Thermal pallet covers
Gel ice packs
Temperature data loggers