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
Thermal pallet covers are a very effective way of protecting loads from the heating effect of sunlight, as well as other sources of radiant heat. Some covers contain insulation material for added protection.
Gel Ice Packs
As heat finds its way into the pallet, gel ice packs absorb it, using that energy to convert the ice back into gel, instead of it warming the pallet. When combined with a thermal pallet cover, cool temperatures can be maintained for days.
Temperature Data Loggers
When inserted in a load, temperature data loggers record temperatures at a set interval. Cargowise supplies different variants from 30 to 120 day loggers at various temperature levels. They are essential for compliance and maintaining product quality.
