ASTM D4169 & ISTA Series Distribution Simulation Testing
Packages must be able to withstand the typical events associated with distribution of the product without defect or loss of sterility. Manufacturers are responsible for evaluating and documenting the package’s ability to protect the product throughout handling, distribution as well as within the storage environment. ASTM and ISTA provide a majority of the industry guidance on distribution simulation testing. ASTM D4169, ISTA 2 Series and ISTA 3 Series are the primary test standards that are used for distribution simulation. As members of ASTM and ISTA, DDL’s engineers are well versed in these sometimes difficult to understand test standards. DDL consults with customers during the quotation process so that test sequencing and methods are understood and the proper testing is selected as dictated by the package design and intended distribution environment.
Distribution Simulation Testing Standards
This test method is performed by subjecting shipping units to a test plan consisting of a sequence of hazard elements which would be encountered in various distribution environments. A simple example would be shock testing followed by drop testing, then vibration and finally compression testing. 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 of the product is well understood and defined.
Through the utilization of tests simulating the shocks and stresses normally encountered during handling and transportation, these tests provide a means for a manufacturer to assign the probability of safe arrival for their packaged products.
Sample Size – The optimum sample size is ten (10) shipping units with the primary packages assembled as intended for shipment.