TABLE OF CONTENTS Patrick J. Nolan
DDL Inc., Eden Prairie, Minnesota
This chapter provides an overview of the process of designing and developing a package system for a medical device. A comprehensive discussion of this subject is beyond the scope of this chapter; however, numerous references are provided for further detail and study of the subject. The information provided in this chapter is a compilation from the references cited as well as from the experiences of the author in developing package systems for medical devices.
Implementation of a standard for the process of designing and developing a package for terminally sterilized medical devices is essential to the overall endeavor of marketing a sterile device in the international and domestic communities. It is incumbent upon the medical device manufacturer to ensure that a safe, reliable, and fully functional device arrives at the point of end use. This assurance is complicated by the fact that the package must maintain its barrier integrity throughout its intended shelf life and through the rigors of manufacture and shipping and handling. The total product development effort must include the packaging design process and encompasses the package design, manufacturing process, sterilization process, and distribution environment effects. The intended sterilization method and the intended use, shelf life, transport, and storage all influence the package design and choice of packaging materials.
The issue of developing a package system seems uncomplicated and elementary. In actuality, the package process is complicated by the fact that device packages must allow effective sterilization of their...
