It is the responsibility of the manufacturer to evaluate the package's ability to protect the product throughout handling, distribution, and within the storage environment. The package must be able to withstand the typical events associated with distribution of the product without defect or loss of sterility. The testing services that DDL uses for simulating the typical events associated with the distribution environment include published ASTM standards and other industry test methods.???

ASTM D 4169 Standard Practice for Performance Testing of Shipping Containers and Systems

This test method is performed by subjecting shipping units to a test plan consisting of a sequence of hazard elements (eg. shock, drop, vibration, compression) which are encountered in various distribution environments. The test plan provides a uniform basis of evaluating, in a controlled and repeatable laboratory environment, the ability of the shipping units and contents to withstand the distribution environment. The test

plan uses established testing services methods at levels representative of those encountered in actual distribution. The Distribution Cycle (DC) most commonly used for medical device packages is DC 13 which is designed for the small parcel and overnight shipping mode. Customized distribution cycles can be designed when the anticipated distribution.