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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)
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