11. USP CLASS VI "BIOSTABLE" MATERIALS

A. Problem/Issue

Many times in the course of medical/surgical design it is necessary to use materials that will not contaminate the human body. This applies to any particulate, vapors, and leachable residues that can cause such results as thrombosis, tissue irritation, and/or body damage of many types. Sometimes a company wishes to use another material-besides those they are already using-in order to meet present requirements.

B. Analysis

We have analyzed many polymer/plastics that are used in the medical environment and continue to do so. We maintain a database of materials that are more stable than commonly used polymers in other industries. We work with a number of compounders to locate a specialty compound that meets almost any requirement. Often testing documents can be provided to lessen the time necessary to validate a process using in-house resources.

C. Solution/Results

We believe the experience gained from working in the medical industry for many years is invaluable for both product and process designs. We have the background necessary to suggest alternative materials when necessary.