27 May 2025
Material qualifications for raw materials and components used for container closure systems, infusion sets, single-use systems for pharmaceutical manufacturing and medical devices can take a variety of forms. These components are key factors in product safety and efficacy. Raw material suppliers must be able to assure their clients that the materials are fit for purpose in pharmaceutical and medical device applications. At the same time, device and pharmaceutical companies want to know they’re receiving appropriate materials and components before getting too far into the development process. The materials and components also must be able to demonstrate the end product will perform as intended. Several guidelines from the U.S. Pharmacopeia (USP), European Pharmacopoeia (EP), Japanese Pharmacopoeia (JP), U.S. Code of Federal Regulations (CFR) and International Organization for Standardization (ISO), among others, exist for different applications and materials. Specific guidelines are available for various types of drug containers, needles, nutrition preparation containers, blood containers and elastomeric closures to name a few. Packaging and other materials may be plastic, glass, rubber or metallic in nature with slightly different testing requirements. Several tests, including those listed in the accompanying chart, look at the materials from various chemical perspectives, such as acidity/alkalinity, oxidative properties, total extractables and extracted metals, identification, and particle size, to name a few. The accompanying chart provides an overview of some of the more common testing types and guidance on what testing may be required for different material and product types.