Pharmaceutical applications of polymers including packaging, medical devices and manufacturing equipment. Consistent with its mission to insure the safety and quality of pharmaceuticals, the United States Pharmacopeia has historically included monographs for plastic, glass and elastomeric materials intended for pharmaceutical packaging (but indiscriminately used in other applications). In general, these monographs share a common emphasis in terms of addressing extracted substances, as it through the action of the extracted substances that the quality and safety of pharmaceutical products are impacted by packaging, devices and manufacturing equipment.
As the scientific understanding of extractables and leachables has evolved, especially in the area of supporting analytical chemistry, a point was reached where the existing USP chapters no longer met the high standard of good science and a systematic effort was undertaken by the USP to re-invent relevant monographs involving glass, plastic and elastomeric materials, and considering both chemical and biological characterization. Additionally, the drafting of new monographs on new materials (e.g., metallic materials) and new applications (manufacturing equipment, medical devices) have been, are being, or will be drafted.
The purpose of this presentation is to provide an overview of the USP efforts in this area, focusing on the harmonized methodology that the USP has used to revise its whole approach to the topic of the safety and applicability of materials used in pharmaceutical applications.