Medical Device Link.

Originally Published PMPN July 2004

Regulatory Focus

A new testing protocol that provides an enhanced approach to laboratory simulations of distribution environments will be released by the end of this year.

ISTA Project 4AB, currently in alpha testing, was developed by the International Safe Transit Association (ISTA). It enables users to bring data from the field into the lab and is designed to help medical device packagers ensure their packages hold up during shipping. 

In its current form, the Web-based application covers all typical hazards and incorporates the latest available field data. Once an item to be shipped and the distribution system, means, and configurations are defined, a test plan is generated without any further input. When finished, it will closely tie the tests and sequence to a user-defined pattern of distribution and will not require the user to make any quantitative field measurements. 

“This is designed to be the premier enhanced-simulation performance test in the industry,” says Bill Kipp, ISTA education director and consultant for W.I. Kipp Co. (Monterey, CA). “We should have the beta release out by this fall, ready for actual use and verification. Our intent is to have a full release by the end of the year.” He calls the current alpha version a “very rudimentary version that has only been released to top-level sponsors.”

During the recent Dimensions.04 conference in Orlando, FL, Kipp presented a paper titled, “ISTA Project 4AB: Behind the Scenes of Alpha Release.” In that presentation, he described the program as incorporating “a breadth of complexity that would be impractical or impossible in a printed test procedure.” While the program does require detailed knowledge of the target distribution environment, it does not demand quantitative user measurement of the distribution environment and translation into test definitions, he says. 

ISTA Project 4AB’s main features are as follows:

After a basic description of the product and package, including size and weight, the user is asked to choose a particular type of package and method of handling. Packages included are corrugated and wood boxes, reusable plastic containers, sacks/bags, cylindrical containers, unit loads, bulk, and intermediate bulk containers. Handling types include small parcel, manual, manual-controlled axis, and mechanical. The package and handling types, along with the package weight, link to 53 specific handling test tables.

The application’s user is next asked to identify load-bearing member materials for stacking and compression situations. The choices are corrugated/ fiberboard, plastic, corrugated and plastic combinations, wood, metal, glass, and other. Along with stacking heights, package dimensions, and storage times, this information is used to calculate the applied forces for compression tests. 

At this point, the program processes the user-definition of the distribution sequence. There are three fundamental types of distribution elements: handling, warehouse storage, and transportation. The latter element presents a choice of truck, rail, or air modes, with a total of eight different random vibration profiles. It also then asks for the trip length and for the height that packages can be stacked in a vehicle.

The user now sets off a distribution sequence by setting parameters for the first distribution element and clicking the button. The program will configure a corresponding test element and add it to the test plan. This is repeated for the remaining distribution elements until the distribution sequence is fully described. 

Kipp explains that there will be further tweaks before the beta version is released. For example, the compacting of raw test elements into finalized test plans, completion of a help file, incorporation of atmospheric conditions, and addition of file operation features should all show up in the next version. He says there is also a need for more actual transportation/distribution environment data to be analyzed, compiled, and incorporated into the program. 

Copyright ©2004 Pharmaceutical & Medical Packaging News