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Temperature Standards for Cold Chain Logistics

Posted by Michael Steedman on Aug 10, 2022 4:19:01 PM
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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.

AdobeStock_30535486 cold chain logistics

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.

RxCC_Inline2_0116

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.

Thermal pallet covers

Thermal pallet cover to keep product chilled or frozen

Gel ice packs

Gel Ice packs for keeping palletised loads chilled

Temperature data loggers

Temperature data loggers for monitoring temperatures in transit or during storage

 

Topics: temperature control, transporting chilled products, cold chain logistics, temperature control standards

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