Both of these methods are being developed for evaluation in the Office of Science and Technology. A Taber Abraser was purchased and set up over the past year. An engineering design was developed to minimize the likelihood of results being confounded by equipment parameters. Preliminary tests have been done to help develop appropriate protocols for the full battery of abrasion tests. The preliminary tests have forced OST to consider clearly identifying cleaning parameters and specifying equipment parameters that have not been positively identified in protocols submitted to the Agency by companies using the Taber as a test method.
Samples are to be tested using a specific protocol developed in-house.
Also under development has been a simpler, constructable model of the Howmedica inverted pin on sample method. A design was produced in the summer, and parts for the equipment were purchased. Unfortunately, new requirements make the current design less than optimal. Expectations are that the equipment will be redesigned and built over the next year. This study was designed to determine whether the alleged health threat of epidemic wound dehiscence was genuine, and to develop a test method which can be used by ODE as part of a performancebased standard for the integrity of foil-type device packaging.