Validating Medical Packaging de Ronald Pilchik

Validating Medical Packaging

Ronald Pilchik

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.

Citește tot Restrânge

Cuprins

INTRODUCTION. What is Validation? PACKAGE DESIGN VALIDATION. Elements of Package Design. Package Design Issues. Validation Flow Chart. Simulation Criteria. Qualified Suppliers. PACKAGE PROCESS VALIDATION. Introduction. Process Validation. IQ, OQ, PQ. Process Capability Studies. Example. PUTTING IT ALL TOGETHER: THE VALIDATION PROTOCOL. The Validation File. File Maintenance. Employing the Process. Example. REGULATORY ACTIVITIES. Selected Case Studies. Packaging Non-Compliances. Industry Generated Support Documents. HACCP. Appendix.

Descriere

The FDA establishes the manufacturer's responsibility for medical device packaging, but provides no direction on how to achieve compliance. Highlighting the recent development in industry regulations, this book demystifies the validation procedure. The author presents real-life examples and case studies, templates for creating and maintaining a validation file, and explains how the process and regulation works. He addresses the specific needs for validation of packaging for medical devices and covers laws, regulations, guidelines, and process capability studies. The book shows readers how to develop and implement a simple validation process for package design and processing.