Packaging materials used for medical devices including foil, polymeric materials, coated paper, printing ink, adhesives, etc. inside sterile barrier systems may have direct or indirect contact with the patients, therefore should be carefully evaluated to ensure the safety and efficacy of the medical devices. In this presentation, a chemical evaluation focusing on printing inks, a component regularly used for packaging of medical devices will be discussed to illustrate an analytical testing approach and critical technical expertise required to support new product development and product life cycle management.
Specifically, 29 new printing inks, in three ink formulations following gamma or ethylene oxide sterilization were evaluated in compliance with ASTM standard F2475-11: Standard Guide for Biocompatibility Evaluation of Medical Device Packaging Materials. ASTM F2475-11 points out that specific attention should be paid to the potential for indirect contact components such as inks, varnish and adhesive to volatilize and migrate through the primary barrier into the product. In this study, the volatile organic compounds (VOCs) of the ink samples were characterized by Dynamic Headspace Gas Chromatography with Mass Spectrometry (DHS-GC-MS). Dynamic headspace has its unique advantages when analyzing the presence of VOCs in solid samples compared with static headspace. With adsorbent trap and cryogenic focusing, dynamic headspace is more sensitive than static headspace in detection of trace levels of impurities, contaminants, or hazardous compounds.
Technical challenges encountered in this study will be highlighted, special considerations regarding extraction conditions, unknown identification, and semi-quantitation of VOCs will be discussed.