Temperature & Pharma

Cold Chain

Definition

Cold chain refers to a temperature-controlled supply chain system that maintains specific temperature ranges for temperature-sensitive pharmaceutical products, vaccines, and biologics during storage and transportation. In air cargo operations, the cold chain ensures these products maintain their potency and effectiveness through continuous temperature control from origin to destination. The standard temperature range for most pharmaceutical cold chain shipments is 2°C to 8°C (35°F to 46°F), as required by FDA guidelines and IATA Temperature Control Regulations. Since July 2013, IATA requires a Time and Temperature Sensitive label and Standard Acceptance Checklist for all cold chain pharmaceutical shipments.

Examples

A Lufthansa Cargo shipment moves COVID-19 vaccines from Frankfurt (FRA) to Miami (MIA) under AWB number 020-45876543, where the shipment must maintain 2°C to 8°C throughout the 10-hour flight using active temperature-controlled containers and continuous monitoring. A FedEx Express cold chain shipment transports insulin from Memphis (MEM) to Tokyo Narita (NRT) on AWB 023-67891245, requiring specialized packaging with dry ice and temperature data loggers to document compliance with the required -20°C frozen storage conditions during the 14-hour transit.

Also known as

  • cold chain logistics
  • cold chain cargo
  • temperature controlled cargo
  • refrigerated cargo
  • chilled cargo
  • temperature-sensitive cargo
  • cold chain pharma
  • temp controlled
  • cold chain freight
  • cool chain

Frequently asked questions

What specific temperature range must cold chain pharmaceutical shipments maintain during air transport?
Most pharmaceutical cold chain products must be maintained between 2°C to 8°C (35°F to 46°F), though some vaccines require frozen storage at -20°C, and ultra-cold products like certain COVID vaccines require -75°C storage. Temperature requirements are product-specific based on approved storage conditions defined in each product's labeling.
What IATA documentation is required for cold chain shipments?
Since July 2013, IATA requires a Time and Temperature Sensitive label and Standard Acceptance Checklist for all temperature-controlled healthcare shipments. Shippers must also comply with IATA Temperature Control Regulations (TCR), which contain packaging, documentation, and handling requirements. If dry ice is used for cooling, packages must display "Dry Ice," UN 1845 code, and net weight, with maximum limits of 2.5 kg per package on passenger flights or 200 kg on cargo flights.