1. INTRODUCTION

This chapter addresses the fitness-for-intended-use functional suitability requirements of packaging/delivery systems that are intended for parenteral dosage forms as defined in Injections and Implanted Drug Products 〈1〉 and that include primary packaging components partially or completely made of elastomeric material. Elastomeric components, when properly fitted with dimensionally compatible packaging/delivery systems, are intended to protect and contain the system’s contents while enabling safe and effective product access at the time of use.