ABSTRACT
Parenteral products are filled into primary packaging that is either glass or plastic. Many primary packaging systems, including vials, all bottles except for solutions for irrigation, syringes, and cartridges, are closed with some kind of rubber stopper, be it the closure on the vial or bottle or the septum and plunger for the syringe and cartridge. Irrigating solutions are packaged in glass bottles with screw caps rather than rubber closures. Products for topical application to the eye are packaged into plastic droptainers with plastic screw caps or, for ophthalmic ointments, into aluminum tubes and capped with plastic screw caps. Of course, all primary packaging is sterilized either prior to filling for aseptic processed products or terminally sterilized. This chapter focuses on some of the basic chemistry principles of glass (1-4), rubber (5-9), and plastic materials (10-12) and will highlight concerns about extractables and leachables from these surfaces (13-19). A review paper on which this chapter was based can also be a good source of information with additional references and coverage of convenient packaging delivery systems (20).
