Performance Testing - Sterile Barrier

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

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Fill out the form below to enquire about becoming a member or affiliate to the SBA:

Membership is open to Manufacturers of Sterilisation products or related services, with sales in Europe. Affiliation is open to companies/trade associations/healthcare professionals who are Responsible Users of SBS or represent those that are. Potential members or affiliates 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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