Plastics in Medical Devices

Plastics in Medical Devices

Properties, Requirements, and Applications

2nd Edition - November 21, 2013

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  • Author: Vinny R. Sastri
  • eBook ISBN: 9780323265638
  • Hardcover ISBN: 9781455732012

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Description

Plastics in Medical Devices is a comprehensive overview of the main types of plastics used in medical device applications. It focuses on the applications and properties that are most important in medical device design, such as chemical resistance, sterilization capability and biocompatibility. The roles of additives, stabilizers, and fillers as well as the synthesis and production of polymers are covered and backed up with a wealth of data tables. Since the first edition the rate of advancement of materials technology has been constantly increasing. In the new edition Dr. Sastri not only provides a thorough update of the first edition chapters with new information regarding new plastic materials, applications and new requirements, but also adds two chapters – one on market and regulatory aspects and supplier controls, and one on process validation. Both chapters meet an urgent need in the industry and make the book an all-encompassing reference not found anywhere else.

Key Features

  • Comprehensive coverage of uses of polymers for medical devices
  • Unique coverage of medical device regulatory aspects, supplier control and process validation
  • Invaluable guide for engineers, scientists and managers involved in the development and marketing of medical devices and materials for use in medical devices

Readership

Engineers, scientists, and managers involved in the design and manufacture of medical devices. Engineers and scientists involved in the tech support for and development and marketing of materials for use in medical device manufacture. Other professionals involved in the medical device industry, the clinical use of medical devices, and related regulatory and compliance issues. The medical device supply chain, where Process Validation and Supplier Controls are a requirement

Table of Contents

  • Dedication

    Preface

    About the Author

    1. Introduction

    1.1 Introduction

    1.2 Medical Device Definition

    1.3 Types of Devices

    1.4 Materials Used in Medical Devices

    1.5 Medical Devices—Material Selection Process

    1.6 Organization of This Book

    References

    2. Regulations for Medical Devices and Application to Plastics Suppliers: History and Overview

    2.1 History and Introduction

    2.2 United States Regulations

    2.3 ISO 13485 (European and Global Standard)

    2.4 Other Countries

    2.5 Global Harmonization Task Force (GHTF)

    2.6 Applicability of the Regulations to Material Suppliers

    2.7 Conclusion

    References

    3. Materials Used in Medical Devices

    3.1 Introduction

    3.2 Metals

    3.3 Ceramics and Glass

    3.4 Plastics

    3.5 Why Plastics?

    3.6 Types of Plastics

    3.7 Homopolymers and Copolymers

    3.8 Polymer Blends and Alloys

    3.9 Conclusion

    References

    4. Material Requirements for Plastics Used in Medical Devices

    4.1 Introduction

    4.2 Material Characterization

    4.3 Sterilization

    4.4 Chemical Resistance

    4.5 Biocompatibility

    4.6 USP Class VI

    4.7 ISO 10993

    4.8 Shelf Life and Aging

    4.9 Joining and Welding

    4.10 Conclusion

    References

    5. Polymer Additives Used to Enhance Material Properties for Medical Device Applications

    5.1 Introduction

    5.2 Types of Additives

    5.3 Things to Consider When Using Additives

    5.4 Plasticizers

    5.5 Wear-Resistant and Lubricious Additives

    5.6 Pigments

    5.7 Laser Marking

    5.8 Radiopaque Additives

    5.9 Antimicrobials

    5.10 Conductive Fillers

    5.11 Nanoadditives

    5.12 Stabilizers

    5.13 Conclusion

    References

    6. Commodity Thermoplastics: Polyvinyl Chloride, Polyolefins, and Polystyrene

    6.1 Introduction

    6.2 Polyvinyl Chloride (PVC)

    6.3 Polyethylene (PE)

    6.4 Polypropylene (PP)

    6.5 Cyclo Olefin Copolymers (COCs)

    6.6 Polystyrene (PS)

    6.7 Conclusion

    6.8 Commodity Thermoplastics Suppliers

    References

    7. Engineering Thermoplastics: Acrylics, Polycarbonates, Polyurethanes, Polyacetals, Polyesters, and Polyamides

    7.1 Introduction

    7.2 Acrylics

    7.3 Polycarbonates (PCs)

    7.4 Polyurethanes (PUs)

    7.5 Polyacetals

    7.6 Polyesters

    7.7 Copolyesters

    7.8 Polyamides

    7.9 Conclusion

    7.10 Engineering Thermoplastic Suppliers

    References

    8. High-Temperature Engineering Thermoplastics: Polysulfones, Polyimides, Polysulfides, Polyketones, Liquid Crystalline Polymers, and Fluoropolymers

    8.1 Introduction

    8.2 Polysulfones (PSUs)

    8.3 Polyimides

    8.4 Polyamide-Imides (PAIs)

    8.5 Polyphenylene Sulfide (PPS)

    8.6 Polyarylether ketones

    8.7 Liquid Crystalline Polymers (LCPs)

    8.8 Fluoropolymers

    8.9 Conclusion

    8.10 High-temperature Engineering Thermoplastics Suppliers

    References

    9. Other Polymers: Styrenics, Silicones, Thermoplastic Elastomers, Biopolymers, and Thermosets

    9.1 Introduction

    9.2 Styrenics

    9.3 Silicones

    9.4 Thermoplastic Elastomers (TPEs)

    9.5 Biopolymers

    9.6 Thermosets

    9.7 Conclusion

    9.8 Suppliers

    References

    10. Purchasing Controls and Supplier Quality for Medical Device Manufacturers and Their Suppliers

    10.1 Introduction

    10.2 Plastics Resin and Processing Suppliers and Purchasing Controls

    10.3 FDA 21 CFR Part 820 Quality System Regulation and ISO 13485 Standard on Purchasing Controls

    10.4 Global Harmonization Task Force (GHTF) Guidance Document on Purchasing Controls

    10.5 GHTF Guidance Document on Inspection of Purchasing Controls

    10.6 Conclusion

    References

    11. Process Validation for Medical Device Manufacturers and Their Suppliers

    11.1 Introduction

    11.2 Process Validation and the Applicable Regulations and Standards

    11.3 Processes That May Be Verified

    11.4 Processes That Require Validation

    11.5 Process Validation Overview

    11.6 Process Validation Planning and the Master Validation Plan

    11.7 Process Validation Prerequisites

    11.8 Process Development and Engineering Studies

    11.9 Installation Qualification (IQ)

    11.10 Operational Qualification (OQ)

    11.11 Performance Qualification (PQ)

    11.12 Process Validation Summary Report

    11.13 Manual Processes

    11.14 Automated Processes and Software Validation

    11.15 The Validation Life Cycle

    11.16 Revalidation

    11.17 Conclusion

    References

    Appendix

    Index

Product details

  • No. of pages: 336
  • Language: English
  • Copyright: © William Andrew 2013
  • Published: November 21, 2013
  • Imprint: William Andrew
  • eBook ISBN: 9780323265638
  • Hardcover ISBN: 9781455732012

About the Author

Vinny R. Sastri

Vinny Sastri, Ph.D., is the President of Winovia, LLC, a consultancy company specializing in quality management systems, notably in the area of medical devices. Dr. Sastri’s areas of expertise include FDA and ISO quality management systems for medical devices and pharmaceuticals, product development processes, design controls, manufacturing and process validation, risk management, six sigma and design for six sigma, CA/PA, and materials. He is a certified Six Sigma black-belt, and has a strong track record in leading, managing, establishing and implementing growth and quality initiatives into client organizations around the world, resulting effective quality management systems and operational excellence. Dr. Sastri was on the faculty of the Association for the Advancement of Medical Instrumentation (AAMI) that provides training (along with the FDA) on the FDA Quality Systems Requirements and Industry Practice, Design Controls, Process Validation and Risk Management to the medical device industry. He now conducts public and in-house training through his company Winovia LLC. Prior to starting Winovia, Dr. Sastri held global leadership positions in technology, quality, manufacturing and marketing in companies including BASF, AlliedSignal and General Electric. He earned a Ph.D. from Rutgers University, completed post-doctoral work at Brooklyn Polytechnic Institute, and was an Adjunct Professor at Virginia Commonwealth University in Richmond, Virginia. Dr. Sastri has over 20 publications and 6 patents, and has presented at many international conferences and webinars in the United States, Europe, and Asia.

Affiliations and Expertise

President, Winovia, LLC, USA

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