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Sterilisation of Polymer Healthcare Products
Product Code: SPHP/06
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Rapra Technology, 2005
By Wayne Rogers
The use of polymers in medical technology continues to grow and provides major business opportunities for companies who service the medical industry. Sterilisation has always been challenging but sterilisation of polymer healthcare products is an even greater challenge – how do you sterilise without adversely affecting the end use or the end user? This comprehensive reference supplies insights into this developing field.
Sterilisation of Polymer Healthcare Products offers a thorough description of the conventional methods of ethylene oxide, gamma and electron-beam radiation, steam and dry heat sterilisation as well as covering newer methods such as hydrogen peroxide/plasma, gluteraldehyde, steam – formaldehyde, peracetic acid, chlorine dioxide and ozone.
With the many possible ways to sterilise healthcare products, and new techniques being developed all the time, the author identifies the variety of factors and functions that must be taken into account, such as the requirement for an understanding of physical, chemical and biological properties, design and manufacturing processes, quality control and regulatory issues.
This book discusses the evaluation of candidate materials and components for compatibility with the different sterilisation methods. From this point methods may be chosen and materials screened for biocompatibility, devices manufactured and samples tested, and a validation process chosen.
Sterilisation of Healthcare Products is a necessary and worthwhile reference for medical device manufacturers and polymer suppliers, as well as purchasing and quality assurance managers in the healthcare industry. It is designed to be of use to anyone already working in the field of sterilisation of healthcare products but it will be equally useful to someone about to start working in the field.
About the author...
Wayne Rogers’ interest in sterilisation and polymers began 34 years ago when he worked at the Castle Steriliser Research Laboratory on the feasibility of using sterilisers in military field hospital units. He has since continued to work in the healthcare sector for UCLA, Pharmaseal Laboratories, Baxter Travenol, McGaw Laboratories, in Central Services at a large hospital, Syntex and for an Eli Lilly subsidiary where he developed, installed and validated a unique ethylene sterilisation process.
Wayne has served on the Editorial Advisory Board of Medical Device and Diagnostic Industry Magazine (MDDI) for over 15 years, and is also the co-author of a Rapra Review Report entitled Polymers in Medical Applications.
Format: Soft-backed, 255 x 190 mm, 326 pages.
ISBN: 1-85957-490-4
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Reviewed.
"…this book will be valuable as a general reference and introductory resource to managers, microbiologists, design assurance and regulatory team members involved in developing new polymers or polymer-based products for the health care industry. The risks of disregarding sterilization requirements during design of product, packaging, facilities, or control systems should be apparent to all after reading this book."
Ajay Gupta, Senior Engineer, Boston Scientific Corporation
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Contents
Preface
Introduction
Steam Sterilisation
Ethylene Oxide Sterilisation
Radiation Sterilisation
Dry Heat Sterilisation/Depyrogenation
Sterilisation by Filtration for Aseptic Processing
Control of Sterilisation Labelling
1 Sterilisation Qualities and Science
1.1 Purpose
1.2 Definition of Sterilisation
1.3 Ideal Qualities of Sterilisation
1.3.1 Trust
1.3.2 Sterilisation
1.4 Statistics, Sterility and Sterilisation
2 General Overview of Control Sterilisation and Related Methods for Healthcare Products and Polymers
2.1 General Considerations of Sterilisation Methods
2.1.1 Sterilisation Encompasses a Variety of Areas
2.1.2 Sterilisation and Product Design
2.1.3 Release of Sterilised Products
2.1.4 From In-House to Outside Sterilisation
2.2 Standards
2.2.1 Harmonisation of Sterilisation Criteria
2.2.2 Harmonisation of Standards (ISO)
2.2.3 Some Biological Standards
2.2.4 ISO Sterilisation Standards
2.3 Sterility Assurance Levels (SAL)
2.4 General Considerations of Products, Polymers, and Materials for Sterilisation
2.4.1 Deformation and Degradation
2.4.2 Deterioration, Discolouration, Aesthetics
2.4.3 Shelf Life
2.4.4 Residuals and Extractables
2.4.5 Biocompatibility
2.4.6 Reprocessing
2.4.7 Costs
2.4.8 Availability
2.4.9 Acceptability
2.4.10 Packaging
2.4.11 Process Conditions and Effects
3 Steam Sterilisation of Healthcare Products and Polymers
3.1 General Considerations
3.1.1 Polymers and Materials
3.2 Steam Sterilisation with Heat, Liquid and Moisture Compatible Materials
3.2.1 Common Materials Sterilised by Steam
3.2.2 The Specific Types of Steam Sterilisation Processes
3.2.3 Validation Procedure of Steam Sterilisation of Healthcare Products
3.3 Considerations for Qualification
3.4 Technical Review and Design Considerations
3.4.1 Issue SVD
3.5 Metrology Requirements and Guidance
3.5.1 Calibration
3.5.2 Basic Considerations of Calibration System (Temperature Measurement)
3.6 Know the System
3.7 Performance Qualification Testing and Guidance
3.7.1 Qualification Starts with a Sterilisation Validation Document (File)
3.7.2 Equipment Qualifications (Guidance)
3.7.3 Cycle (Process) Development
3.8 Heat Distribution
3.8.1 Review of Outlined Elements in Heat (Temperature Distribution)
3.9 Heat Penetration Portion of the Qualification Study
3.10 Microbiological Validation
3.10.1 Bioburden and Relative Thermal Resistance
3.10.2 Biovalidation
3.10.3 Biological Indicator System
3.11 Final Review
3.11.1 Documents/Organisation for Protocol
3.11.2 Updates
3.11.3 Adequate Processing Can be Determined only by Experience with Specific Liquids or Components
3.12 Low Steam-Formaldehyde – a Hybrid Method for Heat Sensitive Products
4 Statistics in Sterility Assurance and Sterilisation Validation of Healthcare Products
4.1 Background and Definition
4.2 Determination of Sterility
4.3 Kinetics of Microbial Inactivation
4.4 Design of a Sterilisation Process
4.5 Sterilisation Validation
4.6 Summary
5 Radiation Sterilisation
5.1 Some Unexpected Radiation Results and Considerations for Evaluating Radiation
5.2 Radiation Ionising Sources
5.3 Radiation Sterilising Doses
5.4 Gamma Radiation Facility, Equipment and Product Handling
5.5 Conveyor System and Equipment
5.6 Considerations of a Dosimetry System
5.7 Dose Mapping and Product Qualification
5.8 Routine Standard Dosimetry
5.9 Processing Controls
5.10 Plastic Design Considerations During Validation of Polymerised Materials for Irradiation
5.11 Processing Considerations for Medical Plastics to be Sterilised by Ionising Radiation
5.12 Test Parts Used for Validation Solvent/Chemical Attack Must be Typical in all Respects of Radiation on these Environmental Exposures
5.13 Control of Polymer Processing for Irradiation
5.14 Improvements in Radiation Sterilisation Can be Achieved by Minimising Radiation Dose and Parameters to Materials, Packaging and/or Product
5.15 Healthcare Product Biocompatibility and Sterilisation
5.15.1 A Medical Device Must Be Adequately Designed to be Safe for Its Intended End Use, After Sterilisation
5.15.2 Biocompatibility and Material Standards
5.15.3 Definitions
5.15.4 Categorisation of Medical Devices
5.15.5 Categorisation by Nature of Contact
5.15.6 Categorisation by Duration of Contact
5.15.7 Biological Tests - Category Descriptions
5.15.8 Implantation Tests
5.16 Purpose and Meaning of Biocompatibility Testing of Medical Devices and Materials
5.17 Additional Material Biocompatibility Considerations
5.18 An Abbreviated Discussion of Material Biocompatibility Tests
5.19 Assessing Material Risks by Other Means
5.20 Some Introductory/Design Considerations
5.20.1 When to Consider Testing
5.20.2 When Not To Perform Full Biocompatibility Testing
5.20.3 Biocompatible Consideration and Other Points
5.20.4 Processing Factors To Be Considered Which May Affect Materials
5.20.5 Approaches and Strategies to AddressMaterial Testing
5.20.6 Some Considerations and Consequences of Testing a Whole Device or Assembly
5.20.7 Condition(s) of Material/Component, Assembly or Device for Testing and Preparation
5.20.8 Consider appropriate testing requirements and extractions
5.20.9 Biocompatibility and Material Safety Screening Tests
5.20.10 A Technical Review Can Be Made After the Screening Test
5.20.11 Advanced or Confirmatory Tests
5.20.12 Review Data
5.20.13 Some Considerations for Accepting Higher Levels of Toxicity May Exist
5.20.14 Test interpretation may include some customised response(s)
5.20.15 Documentation
6 Ethylene Oxide Sterilisation - Ubiquitous for Most Non Liquid Heat Sensitive Materials
6.1 Cycle Phase Parameters of Ethylene Oxide Sterilisation
6.2 Ethylene Oxide Processing Cycles
6.3 Industrial Qualification of Ethylene Oxide Sterilisation
6.3.1 Validation (Example): Ethylene Oxide Sterilisation Validation Protocol for Healthare Medical Care Product Devices at Contractor(s)
6.3.2 An Example of a Revalidation Test Protocol
6.4 Guidance on EO Sterilisation Process and Statistics
6.4.1 Relative Humidity and Its Role in Sterilisation Processes
6.4.2 Product Temperature
6.4.3 Ethylene Oxide Concentration
6.4.4 Inactivation Factor and SAL: A Microbiological Statistical Expression of Sterilisation Effectiveness
6.5 Guidance on Designing and Developing Sterilisation Parameters
6.6 Ethylene Oxide Sterilisation Can be Improved by Increasing Sterilising Temperatures and Using Heated Aeration as Part of the Overall Process
7 Dry Heat Sterilisation/Depyrogenation for Extremely Heat Tolerant and Non Liquid Materials
7.1 Typical Products, Polymers, and Materials that are Dry Heat Sterilised
7.2 Potential Inactivation Mechanisms of Dry Heat Sterilisation
7.3 Dry Heat Sterilisation
7.4 Sterility Assurance Level of Packaging
8 Alternative Methods of Sterilisation of Healthcare Products, Polymers and Materials
8.1 Healthcare Products
8.2 Gaseous Ozone
8.3 Gaseous Formaldehyde
8.4 Low Temperature Steam Formaldehyde
8.5 Formaldehyde/Solvent/Alcohol
8.6 Glutaraldehyde
9 More Recent Alternative Methods of Sterilisation of Polymer Products
9.1 Peracetic Acid
9.2 Vapour Phase Hydrogen Peroxide
9.3 Chlorine Dioxide
9.4 Peracetic Acid/Hydrogen Peroxide Plasma
9.5 Hydrogen Peroxide Gas Plasma
9.6 Low Temperature Hydrogen Peroxide Gas Plasma
9.7 Chlorine Dioxide
9.8 Gaseous Ozone
9.9 Liquid Sterilants
9.9.1 Glutaraldehyde within Closed Systems
9.9.2 Peracetic Acid
9.10 Chemiclave
9.11 Aseptic Processing
9.11.1 Filtration
9.11.2 Sterile Assembly
10 Potential Applications and Developments of Sterilisation Techniques
10.1 Chlorine Dioxide – Another Look?
10.2 Heat Sterilisation – Something Old but with a Look to the Future
10.3 Pulsed-Light Sterilisation
10.4 Iodine – Something Old, Something Used, Something New
10.5 Radiation – Diversifying and Improving
10.6 Some Other Alternative High Level Disinfectants or Sterilants
10.7 Other Possibilities
11 Summary of Sterilisation for Hospital Products, Polymers and Materials
11.1 Decontamination and Sterilisation of Prions
12 Definitions
Price: £95.00 (Ex VAT)
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