Understanding USP <661> Compliance for PVC Packaging Materials

USP <661> "Plastic Packaging Systems and Their Materials of Construction" is a critical standard for pharmaceutical packaging materials in the United States market. This chapter outlines the requirements for plastic materials used in packaging drug products, including PVC sheets for blister and strip packaging.\n\nKey requirements include physicochemical testing (identification, differentiation, specific gravity, water extraction), biological reactivity testing (in vitro and in vivo), and extractables/leachables assessment. Our medical-grade PVC sheets are manufactured under GMP conditions and undergo rigorous testing to ensure full compliance with all applicable USP <661> requirements.\n\nOur quality control laboratory is equipped with state-of-the-art analytical instruments, including GC-MS, HPLC, and ICP-MS systems, enabling comprehensive extractables profiling and method validation. Each production batch is accompanied by a Certificate of Analysis documenting compliance with all relevant specifications.