ABSTRACT

Glass has traditionally been the material of choice for vials and prefillable syringes because of its clarity, inertness, and excellent gas and moisture barrier properties. This chapter reviews the increasing role of plastic in parenteral drug delivery as well as recent developments in drug delivery devices. It describes the developments in the use of plastics in packaging systems for pharmaceutical drug products with an emphasis on biotherapeutics. The chapter addresses the use of disposable bags made from plastics in packaging large-volume drug substances or drug products in bioprocess development and fill/finish operations, as well. Plastic resins are the most widely used raw materials in global pharmaceutical packaging, particularly for primary packaging, which is usually the smallest unit of distribution or use and is the package which is in direct contact with the contents. The chapter provides the reader with references to key scientific studies and reports as well as examples using commercialized drug products.