The objective of performance testing is to demonstrate that the packaging system provides adequate protection to maintain a sterile barrier throughout the distribution and handling of the product. This is normally done by challenging the system through simulated distribution testing based on either ASTM or ISTA test methods listed here below:

ASTM

  • ASTM  D4169            Standard Practice for performance testing of shipping containers and standard (Vehicle stacking / compression test)
  • ASTM 4332                Standard Practice Conditioning Container, Packages or Packaging components for testing
  • ASTM D4728             Standard Test method for Random Vibration testing of shipping Containers
  • ASTM D999               Vibration testing of Shipping Containers: Method A, B or C
  • ASTM D5276             Standard test Method for Drop Test of Loaded Containers by Free Fall.
  • ASTM D642               Standard Test Method for Determining Compressive Resistance of Shipping Containers, Components, and Unit Loads
  • ASTM D6653             Standard Test Method for Determining the effects of High Altitude on Packaging systems by Vacuum Method

ISTA

  • ISTA 1A         Non-Simulation Integrity Performance Test-Fixed Vibration
  • ISTA 1G         Non-Simulation Integrity Performance Test- Random Vibration
  • ISTA 2A         Partial Simulation Performance Tests
  • ISTA 3A         General Simulation Performance Tests

Membership is open to Manufacturers of Sterilisation products or related services, with sales in Europe. Potential members also need to have implemented a quality management system certified by an accredited certification body.

For more details see Why become a member?

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