Cold Chain Testing Services

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. Thermal mapping is an extension of the Good Manufacturing Practice (GMP) environment that many products are required to adhere to. 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, in order to maintain the stability of medical or pharmaceutical products.

We are an ISO 17025-accredited laboratory and offer a wide range of cold chain and distribution simulation tests based on internationally recognized standards.

Cold chain tests include:

  • 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 D4169 (Standard practice for performance testing of shipping containers and systems)
  • ASTM D4332 (Climatic conditioning)

Technical Support

Our technical support team also offers guidance toward:

  • Packaging evaluations and concept reviews
  • Risk assessment
  • Identification of applicable standards
  • Test planning and protocol development
  • Evaluating prior validations and gap analysis
Contact our team of experts to find out more about our Global Contract Sterilization Services