Cold Chain Testing

Cold Chain Testing Services

What is cold chain testing?

Cold chain testing is the process of evaluating and ensuring the integrity of temperature sensitive products, including medical devices or pharmaceuticals, throughout their distribution and storage in a controlled cold chain environment. This temperature-controlled supply chain includes steps such as transportation and handling to ensure quality and effectiveness of products that are perishable or sensitive to temperature variations.

What is cold chain logistics?

Cold chain logistics is the process of managing the transportation of temperature sensitive products throughout the supply chain, from manufacturing to end-user/patient. Cold chain logistics includes storage, packaging, transportation, and monitoring to ensure the quality and effectiveness of temperature sensitive products.

Validation of temperature-controlled shipping systems

STERIS provides cold chain testing services for packaging designed to transport products that can be affected by normal environmental conditions. Many products are required to adhere to thermal mapping as an extension of the Good Manufacturing Practice (GMP) environment. These services test the packaging solution to show how long it keeps the products in the required conditions, typically between 2°C and 8°C, or in dry ice, to maintain the stability of medical or pharmaceutical products.

Cold chain tests include, but are not limited to:

ISTA 7D (Temperature test for transport packaging)
ISTA 7E (Thermal transport packaging used in parcel delivery system shipment)
ASTM D3103 Thermal insulation performance of distribution packages
ASTM D4332 (Climatic conditioning)
Customer defined conditions can also be accommodated

Technical Support

Our technical professionals also offers cold chain guidance toward:

Packaging evaluations and concept reviews
Risk assessment
Identification of applicable standards
Test planning and protocol development
Evaluating prior validations and gap analysis