The current USP 38/NF 33 Chapter 661 testing contains qualifying analysis methods for plastic packaging materials. These methods contain identification tests and physiochemical tests, but do not fully address the safety and efficacy of the material for its intended use. Starting May 1, 2016, the new USP 39/NF 34 chapter 661.1 and 661.2 series will better characterize the materials to provide more meaningful and rigorous analysis of the polymers that compose packaging materials (USP 661.1) and packaging systems (USP 661.2).
The new monographs provide methods to address the potential migration of organic additives and metal elements used in the polymer industry. While the USP is not harmonized with the European Pharmacopeia (EP), the new monographs follow similar test structure and expectations that the EP has been enforcing for several years.
During this webinar, attendees will learn about the tests involved in the new USP 661.1 for each polymer group, as well as options and views for addressing other polymers, copolymers, and packaging systems. Our objective is to help you determine the required testing for your materials and the requirements for such testing so you will be better able to plan ahead for your product.
Technical Advisor, Chemistry, NAMSA
Tina Hubbell is a Technical Advisor with NAMSA, focusing on Analytical and Chemical testing. She holds a bachelor’s degree in chemistry from the University of Toledo. Before coming to NAMSA about 5 years ago, she worked in an analytical laboratory specializing in chemical separations for volatile organic compounds and ultra-trace mercury measurements. She is an active member of the local American Chemical Society chapter and has held Executive committee positions including a two year appointment as Chair.