Simulated Distribution Testing

Simulated Distribution Testing is performed on sterilized packaging to validate a packaging system, usually in the Operational Qualification (OQ). Samples are normally produced at the extremes of the process window and packaged into the intended final format. They are then sterilized and conditioned; one third in cold, one third in ambient and one third in hot conditions. Samples from low, nominal and high parameters are conditioned at all three levels. Samples are then dropped. The drop height is determined from the assurance level (which is related to the intensity of testing required) and the shipping case weight.

Random vibration testing is performed according to the prescribed assurance level using a vibration table capable of delivering the required power spectral density levels. A second series drop test is performed then the samples are subjected to package integrity testing. Other tests may be included according to the distribution system the test packages will see in practice. For example, a vacuum test to simulate travel at high altitude in a transport plane; a crush test to simulate stacking in a warehouse, truck or sterilizer; or a concentrated impact test to simulate handling in a parcel sorting operation.

ASTM D642 Test Method for Determining Compressive Resistance of Shipping Containers, Components, and Unit Loads

ASTM D4169 Standard Practice for Performance Testing of Shipping Containers and Systems

ASTM D4332 Practice for Conditioning Containers, Packages, or Packaging Components for Testing

ASTM D5276 Test Method for Drop Test of Loaded Containers by Free Fall

ASTM D6344 Test Method for Concentrated Impacts to Transport Packages

ASTM D6653 Test Methods for Determining the Effects of High Altitude on Packaging Systems by Vacuum Method

ASTM D7386 Practice for Performance Testing of Packages for Single Parcel Delivery Systems

ISTA Procedure 3A Packaged-Products for Parcel Delivery System Shipment 70 kg (150 lb) or Less

Drop Tester

Vibration Table