Frances DeGrazio

Frances DeGrazio is Vice President, Marketing and Strategic Business Development at West Pharmaceutical Services, Inc.

Multiple materials are involved in the packaging of drug products in prefillable syringes.

FDA’s May 1999 container-closure guidance has accelerated the requirements for extractable and leachable testing of container-closure packaging components. Since that date, additional recommendations have been made by industry groups to clarify how these issues should be addressed.

During the past 30 years, manufacturers developed sophisticated packaging and delivery systems to support the requirements of traditional and complex biologics, including quality and cleanliness. This article discusses the evolution of packaging and delivery systems for injectable administration systems as the pharmaceutical and biotechnology industry evolved during the past 30 years. It also explores the future of packaging and delivery systems as technology and drug development advance.