A General Overview Of The Suitability For Intended Use Requirements For Materials Used In Pharmaceutical Systems

Rubber materials are widely used in systems used to manufacture, package and deliver therapeutic products. While the rubber material’s nature and composition provides its necessary and desirable performance characteristics, these material properties can have important and potentially detrimental consequences for such therapeutic products. Interactions between these materials and the pharmaceutical products they contact are well known and documented and can result in a change in the product’s composition, which may adversely affect product safety (i.e., the product produces an unanticipated and adverse user response) and/or efficacy (i.e., the product performs in a manner inconsistent with its labeling and indication). Thus, rubber materials used in medical applications must be evaluated to establish their suitability for the intended use, including determining what material components can, and do, migrate into and accumulate in the pharmaceutical product, as it is through the presence and actions of such substances that suitability for use may be compromised. The characterization of materials for their extractables (substances that can migrate) and of products for their leachables (substances that do accumulate) is a necessary and complex part of product development, registration and manufacturing and distribution. This presentation provides a general overview of the suitability for intended use issues associated with materials used with/in therapeutic products.