Page 202 - Biomedical Engineering and Design Handbook Volume 2, Applications

CHAPTER 7

STERILE MEDICAL DEVICE

PACKAGE DEVELOPMENT

Patrick J. Nolan
DDL, Inc., Eden Prairie, Minnesota

7.1 INTRODUCTION 181 7.7 PACKAGE PROCESS VALIDATION 205
7.2 REGULATORY HISTORY 182 7.8 SHELF-LIFE STUDIES 211
7.3 FUNCTIONS OF A PACKAGE 187 7.9 FINAL PACKAGE SYSTEM VALIDATION
7.4 PACKAGE TYPES 188 PROTOCOL 216
7.5 PACKAGING MATERIALS 190 REFERENCE 222
7.6 COMMON TESTING METHODS 198

The objective of this chapter is to provide an overview of the process and techniques of designing
and developing a package system for a medical device. An all-inclusive 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 refer-
ences cited as well as from the experiences of the author in developing package systems for med-
ical devices.

7.1 INTRODUCTION

Implementation of a standard for the process of designing and developing a package for terminally
sterilized medical devices is essential to the overall effort of marketing a sterile device in the inter-
national 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 com-
plicated by the fact that the sterile barrier system 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 system design process and encompasses the following
functions:

• Package design
• Package prototyping
• Manufacturing process validation
• Sterilization process
• Distribution and environmental effects

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