How should absorbable materials be used? How should they be monitored and controlled?
“A little is good; a lot may be dangerous,” asserts Bob Baier, executive director at Industry/University Center for Biosurfaces, University at Buffalo, The State University of New York. “Esters hydrolyze; they break down to acids. If a great deal of absorbable material is present, the acids produced by products of hydrolysis can digest the very bone that is to be repaired.”
Evaluating the performance of absorbable materials and assuring good manufacturing processes must, of necessity, involve a confluence of many areas of specialization, including chemistry, engineering, materials science, surface chemistry, taxonomy, molecular biology, biochemistry – and even critical cleaning. Multiple approaches to validation are needed, because a resorbable material is an inherently dynamic situation.
This cleanroom tip was taken from “Desirable Degradation,” which appeared in the January 2013 issue of Controlled Environments.
