According to the FDA Quality System Regulations, manufacturers must ensure that “device packaging and shipping containers are designed and constructed to protect the device from alteration or damage during the cusotmary conditions of processing, storage, handling, and distribution.” As specific as this statement is, the FDA does not provide instructions on how to achieve compliance. This book demystifies the validation procedure for medical device packaging by providing specific examples and templates for creating and maintaining a validation file. It covers the latest developments in industry regulations, while providing a simplified explanation of how the process and regulations work.

From the Introduction: "...Does the design of the package result in the protection sought after time? Will the sterile barrier created initially hold up during the rigors of processing, storage, handling, and distribution? We must rely on simulation to provide the means to answer these questions. Some simulations, such as compatiblity to sterilization processes, are easily designed because the sterilization process must be rigorously maintained and not altered...Storage, handling, and distribution are entirely different matters..."

Target Audience: Every professional concerned with the validation of medical packaging.

Table of Contents:

Introduction

Package Design Validation

Package Process Validation

Putting It All Together — The Validation Process

Regulatory Activities

Appendix I: HACCP and Its Implications for Sterile Medical Device Packaging

Appendix II: Process Validation Guidance