1st Edition

Validating Medical Packaging

By Ronald Pilchik Copyright 2002
    160 Pages 17 B/W Illustrations
    by CRC Press

    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.

    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)

    Biography

    Ronald Pilchik