Validating Medical Packaging: 1st Edition (Hardback) book cover

Validating Medical Packaging

1st Edition

By Ronald Pilchik

CRC Press

160 pages | 17 B/W Illus.

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Hardback: 9781566768078
pub: 2002-09-27
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Description

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 customary conditions of processing, storage, handling, and distribution." As specific as this statement is, the FDA does not provide instructions on how to achieve their standards. Validating Medical Packaging demystifies the validation procedure for medical device packaging by providing specific examples and templates for creating and maintaining a validation file.

About the author:

Ronald Pilchik has over 30 years of experience in the healthcare manufacturing industry. As principal of the Techmark Group, he provided consulting services to diverse multinational manufacturers on selecting, developing, and validating medical packaging compatible with their sterilization requirements. He has been chairman of the healthcare packaging section of TAPPI, the packaging committee of HIMA, and a member of AAMI's ISO198 working group on packaging. Mr. Pilchik is program chairman of the HealthPack Conference Series on medical device packaging.

Table of Contents

INTRODUCTION

What is Validation?

PACKAGE DESIGN VALIDATION

Elements of Package Design

Package Design Issues

Validation Flow Chart

Simulation Criteria

Qualified Suppliers

Tables 1-6

PACKAGE PROCESS VALIDATION

Introduction

Process Validation: What is It?

IQ, OQ, PQ

Process Capability Studies

Example: XYZ Medical Device Corporation: Validation Protocol-Process Capability Study

PUTTING IT ALL TOGETHER: THE VALIDATION PROTOCOL

The Validation File

File Maintenance

Employing the Process

Example: Package Validation File

REGULATORY ACTIVITIES

Selected Case Studies

Packaging Non-Compliances

Industry Generated Support Documents

HACCP-Furthering the Need for Package Validation

Appendix 1 Operations Manual (impulse Sealer)

Subject Categories

BISAC Subject Codes/Headings:
MED071000
MEDICAL / Pharmacology
TEC016010
TECHNOLOGY & ENGINEERING / Industrial Design / Packaging
TEC059000
TECHNOLOGY & ENGINEERING / Biomedical