Thoroughly authoritative with contributions from experts in the field, this completely revised and expanded second edition of the Medical Device Packaging Handbook details state-of-the-art developments in industry practices and standards related to medical device packaging in a readily accessible format.

Showing how to comply with recent FDA Quality Systems Good Manufacturing Practices (GMP), European Medical Device Directives, ISO 14000, and other international standards and requirements, the book offers entirely new as well as revised chapters on international standards and compliance; sterilization techniques such as vapor phase processes; package validation methods and integrity testing; customer needs; packaging materials; and much more.

From the Preface: “...The packaging field is dynamic — international and domestic regulatory requirements are added periodically, new sterilization methods appear, packaging materials change, new standards are written, packaging and bar-coding equipment becomes more sophisticated, and concern for the environment increases. All of these changes were considered and were instrumental in the decision to revise the first edition...”

Target Audience: Packaging, validation, process, and materials engineers; packaging designers; microbiologists; toxicologists; pharmacologists; pharmacists; drug manufacturers, distributors, and suppliers; quality assurance and food and drug regulatory personnel; and upper-level students in these disciplines.

Table of Contents:

Regulatory Aspects

Package Specifications

Packaging Materials

Package Sterilization Methods

Bar-Code Labeling

International Standards and Compliance

Package Validation

Environmental Packaging Design

Storage Autoclave Case Systems and Instrument Cassette Designs

Packaging Needs for the Health-Care Facility

Glossary

Index