ABSTRACT
This chapter describes the operation of a typical modern elastomeric closure manufacturing plant. In any such plant, irrespective of the company, the major steps in pharmaceutical rubber stopper manufacturing will consist of weighing according to a recipe, mixing, preforming, molding, die-trimming, washing, drying, and packing. Upon acceptance by the control laboratory, raw materials are released for production and a raw material lot number is assigned. The chapter provides an overview of the most important and common types and designs of closures that are used as primary packaging in parenteral applications. Die-trimming of elastomeric closures requires a trimming agent, typically a silicone emulsion, that is then removed by rinsing the freshly die-trimmed stoppers or, at the latest, in the next manufacturing step, which is washing. Qualification of the packaging of elastomeric closures is of particular relevance for functional packaging.
