Distribution Simulation Services

Transportation test methods based on ASTM and ISTA standards

Distribution simulation is a means of applying the same forces and conditions on a packaging system commonly seen in real-world transit. It is a key validation requirement for sterile medical devices, defined within ISO 11607. Transportation testing is also performed for other medical devices and packaged products in various industries. Our test laboratory is ISO 17025 accredited and ISTA certified, with capability for single shipping units and pallets.

Transportation test sequences

STERIS AST offers testing in accordance with the following standards:

  • ASTM D4169 (Standard practice for performance testing of shipping containers and systems)
  • ASTM D7386 (Standard practice for performance testing of packages for single parcel delivery systems)
  • ISTA 1A, 1B, 1C, 1D, 1E, 1G, 1H (Non-simulation integrity performance tests)
  • ISTA 2A, 2B, 2C (Partial simulation performance tests)
  • ISTA 3A, 3B, 3E, 3F, 3K (General simulation performance tests)
  • ISTA 6-AMAZON.COM, ISTA 6-SAMSCLUB, ISTA 6-FEDEX (Member performance tests)
  • ISTA 7D (Temperature tests for transport packaging)
  • ISTA 7E (Testing standard for thermal transport packaging used in parcel delivery system shipment)

Individual test methods include:

  • Climatic conditioning (ASTM D4332, ASTM F2825)
  • Manual handling / drop test and mechanical impact (ASTM D5276)
  • Mechanical handling (ASTM D6055, ASTM D6179)
  • Handling, bridge impact (ASTM D5265)
  • Vehicle stacking / compressive resistance (ASTM D642)
  • Vibration (ASTM D4728, ASTM D999)
  • Low pressure / high altitude (ASTM D6653)
  • Concentrated impact (ASTM D6344)

Packaging material test methods include:

  • Sutherland rub test / label test (ASTM D5264)

Technical Support

Our technical support team also offers guidance toward:

  • Packaging evaluations and concept reviews
  • Risk assessment
  • Identifying suitable 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, Testing and Validation Services.