STM 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. Test sequencing and methods are apprehended and the proper testing is selected as dictated by the package design and intended distribution environment.
Distribution Simulation Testing Standards
ASTM D 4169 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. 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.
ISTA Pre-Shipment Test Procedure for Packages involves 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.
Optimum sample size is ten shipping units with the primary packages assembled as intended for shipment.
Many medical device manufacturers struggle with what they need to do in order to comply with ISO 11607 and which procedure to utilize for performance testing, ASTM or ISTA. Distribution simulation testing is a uniform and repeatable way to evaluate packaging systems by utilizing laboratory equipment, subjecting the system to specific hazards that may occur in the anticipated distribution environment. The primary goal is to have an effective shipping configuration that protects the product during transit and complies with ISO 11607-1. Distribution simulation testing can be thought of as a conditioning element for the test specimens. It is the tests that are carried out after distribution testing that determine whether the specimens pass or fail as there is no variable or attribute data associated with simulation testing. The post-distribution tests can include evaluation of product/package interaction (sterility maintenance), evaluation of product functionality, regulatory compliance. Distribution simulation testing can be performed by following either ASTM International (American Society of Testing Materials) or ISTA (International Safe Transit Association) ASTM International (American Society of Testing Materials) distribution simulation testing incluce D4169, “Standard Practice for Performance Testing of Shipping Containers and Systems” and D7386, “Standard Practice for Performance Testing of Packages for Single Parcel Delivery Systems”. ISTA (International Safe Transit Association) distribution simulation testing incluce 2 Series, “Partial Simulation Performance Tests” and 3 Series, “General Simulation Performance Tests”
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