1. INTRODUCTION

This chapter contains information and guidance to assist in the functional suitability assessment of elastomeric components as part of packaging/delivery systems intended for parenteral dosage forms contained in Elastomeric Component Functional Suitability in Parenteral Product Packaging/Delivery Systems 〈382〉. Such components include primary packaging/delivery system components that are partially or completely made of elastomeric material. Excluded from this chapter are products and their packaging that are regulated as medical devices (e.g., unfilled syringes, infusion administration sets, delivery systems for drug-eluting stents). The proper selection and design of functional suitability assessment studies is based on sound and justifiable scientific principles provided in 〈382〉, 1. Introduction.