Healthcare Sterilisation: Challenging Practices Volume 2

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Florence Webster
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1 Contents 1 Traditional Chemical Sterilisation Methods Ethylene Oxide Sterilisation Green sterilisation (Benefits versus Risks) Ethylene Oxide Residuals Advantages of Ethylene Oxide Sterilisation Some interdependent variables of using Ethylene Oxide Material Considerations with Ethylene Oxide Sterilisation Principles of Ethylene Oxide Sterilisation Factors Affecting Lethality and Demonstrating Effectiveness Microbial Effectiveness of Sterilisation Process Variables and Types of Ethylene Oxide Sterilisation Process Variables Ethylene Oxide Concentration Temperature Relative Humidity Exposure Typical Process Sequences for Ethylene Oxide Sterilisation Staging Air Removal Typical Profile, Phases or Steps in an Ethylene Oxide Sterilisation Process v

2 Healthcare Sterilisation: Challenging Practices Volume Some Types of Ethylene Oxide Sterilisation Cycles Other Ethylene Oxide Sterilisation Methods or Cycles Advantages and Disadvantages of Ethylene Oxide Sterilisation Advantages Disadvantages Recommended/Non-recommended uses of Ethylene Oxide Sterilisation Some General Considerations of the Ethylene Oxide Technique Some Material Compatibility Considerations Safety and Regulations for Using Ethylene Oxide Process Improvement and Enhancement Glutaraldehyde (Liquid) Sterilisation Glutaraldehyde A Fogging or Aerosolised Method Propylene Oxide β -Propiolactone Glyoxal Other Sterilants Chlorine Dioxide Peracetic Acid Hydrogen Peroxide (Liquid, Vapour, No Plasma) Methyl Bromide Low Steam Formaldehyde Conclusions Traditional Liquid Chemical Sterilisation Glutaraldehyde Sterilisation Characteristics of Glutaraldehyde Properties of Glutaraldehyde vi

3 Contents Some Advantages and Disadvantages of Glutaraldehyde Health Risks Sterilisation and High-level Disinfection Formulations Applications and Uses Glutaraldehyde within Closed Systems Two-part Sterilisation Process using Glutaraldehyde Performance Chlorine Dioxide Characteristics Chlorine Dioxide Solutions Performance Some Benefits and Limitations The Future Peracetic Acid or Peroxyacetic Acid Characteristics Performance Biological Monitoring Miscellaneous Benefits An Improved Liquid Peracetic Acid Sterilisation Method Supercritical Carbon Dioxide Sterilisation with Peracetic Acid Additive Chlorine, Hypochlorite and Oxidising Agents Characteristics Performance and Uses Hazards Iodine Characteristics of Iodine Performance vii

4 Healthcare Sterilisation: Challenging Practices Volume Future of Iodine β -Propriolactone Ortho-phthalaldehyde Microbial Characteristics Advantages Disadvantages Liquid Hydrogen Peroxide Alternative or Novel Liquid Sterilants Summary Recommendation(s) Aseptic and Filtration Sterilisation Aseptic Assembly Aseptic Assembly Requires Environmental Control Environmental Precautions Controlled Clean Room Areas Training Personnel Practical Considerations Biocontamination Standards for Biocontainment ISO , Cleanrooms and Associated Controlled Environments - Biocontamination Control - Part 1: General Principles and Methods, 2003 [2] ISO , Cleanrooms and Associated Controlled Environments - Biocontamination Control - Part 2: Evaluation and Interpretation of Biocontamination Data, 2004 [8] ISO Draft International Standard (DIS) , Cleanrooms and Associated Controlled Environments - Biocontamination Control - Part 3: Measurement of the Efficiency of Processes of Cleaning and/or Disinfection of Inert Surfaces Bearing Biocontamination Wet Soiling or Biofilms, 1999 [9] viii

5 Contents Standards for Controlled Environments ISO , Cleanrooms and Associated Controlled Environments - Part 1: Classes of Air Cleanliness, 1999 [1] ISO , Cleanrooms and Associated Controlled Environments - Part 2: Specifications for Testing and Monitoring to Prove Compliance with ISO , 2000 [10] ISO , Cleanrooms and Associated Controlled Environments - Part 3: Test Methods, 2005 [12] ISO , Cleanrooms and Associated Controlled Environments - Part 4: Design, Construction and Start-Up, 2001 [13] ISO Cleanrooms and Associated Controlled Environments - Part 5: Operations, 2004 [14] ISO , Cleanrooms and Associated Controlled Environments - Part 6: Vocabulary, 2007 [15] ISO , Cleanrooms and Associated Controlled Environments - Part 7: Separative Devices (Clean Air Hoods, Gloveboxes, Isolators and Mini-Environments), 2004 [16] ISO , Cleanrooms and Associated Controlled Environments - Part 8: Classification of Airborne Molecular Contamination, 2006 [17] ISO Cleanrooms and Associated Controlled Environments - Part 9: Classification of Surface Cleanliness by Particle Concentration, 2012 [18] Automation and Robotics Aseptic Processing Sterilisation by Filtration Definition of Filter and Sterility ix

6 Healthcare Sterilisation: Challenging Practices Volume Aseptic Processing and Filtration Types of Filters (Filtration) Advantages and Reasons for Using Filters Classes of Filters Disadvantages of using Filters Limitations and Challenges of Aseptic Processing Aseptic Processing Incorporating other Methods of Sterilisation Maximum Contamination Rate for Validation of Aseptic Processing via Filtration Lyophilisation Clean-in-place Sterilisation in Place Isolator Systems Conclusions Design, Materials, Standards and Interrelationships to Sterilisation Design Control and Sterilisation Design and Development Planning Design Input Design Output Design Review Design Verification and Validation Design Transfer and Changes Design Control Conclusion Compatibility of Materials and Polymers Sterilisation Processes for Polymers Chemical Agents Physical Agents Ethylene Oxide Sterilisation Process x

7 Contents Ozone Hydrogen Peroxide Chlorine Dioxide Oxidising Agents Dry Heat Sterilisation Moist Heat (Steam) Sterilisation Radiation Effects of Different Sterilisation Processes on Polymers Ethylene Oxide Sterilisation Process Dry Heat Process Hydrogen Peroxide Ozone Process Radiation Sterilisation Process Some Materials Adversely Affected by Irradiation Moist Heat (Steam) Sterilisation Miscellaneous Concerns Enhancing the Properties of Polymers Using Sterilisation Ethylene Oxide Sterilisation Moist Heat (Steam) Sterilisation Radiation Sterilisation Hydrogen Peroxide and Oxidising Agents Some Properties of Sterilised Polymers Following Implantation Current Alternatives, Non-Traditional and Novel Sterilisation Methods A Few Alternative Sterilisation Methods Traditional Methods Alternative Methods Non-traditional and Accepted Sterilisation Techniques Hydrogen Peroxide with Plasma (without Plasma) xi

8 Healthcare Sterilisation: Challenging Practices Volume Advantages and Reasons for Using Hydrogen Peroxide Vapour with Plasma or without Plasma Ozone Advantages of Using Ozone Disadvantages of using Ozone Some Factors to Consider in the Determination of Alternative Non-traditional Sterilisation Methods versus Traditional Methods Availability Costs Compatibility Ease of Control and Monitoring Novel Sterilisation Methods - The Magic Goes On Hydrogen Peroxide Vapour (without Plasma) Chlorine Dioxide Peracetic Acid Peracetic Acid Hydrogen Peroxide Vapour System Glutaraldehyde Ortho-phthaldehyde The Chemiclave and Low Temperature Steam Formaldehyde Low Temperature Steam-formaldehyde Chlorine and Superoxidised Water with Chlorine Super Critical Carbon Dioxide Future Possibilities Liquid Performic Acid (HCO2OH) Propylene Oxide and Steam Ozone (Cold Sterilisation) Low Temperature Dry Heat xii

9 Contents X-ray Sterilisation - Technology of the Future Combination of High Intensity Ultraviolet and X-ray Radiation Alternative Aseptic Processing Techniques Microwave Radiation Pulsed Light or High Energy Pulsed Light Gas Plasma Sound Waves Future Sterilisation by Nitrogen Dioxide and Peroxynitrites Other Future Sterilants Vapour Phase Performic Acid (HCOOOH) Hydrogen Peroxide and Ozone Summary Sterile Packaging and Sterilisation: A Packaging Perspective Types and Characteristics of Packaging Packaging Considerations will vary for Different Sterilisation Methods and Sterility Criteria The Package Must Protect and Keep the Product Safe The Type of Sterility Claim can Change the Type or Characteristic of the Product Some Considerations for Packaging Sterility Package Selection Other Considerations of Packaging Selection Sterility Assurance Level of Packaging Some Qualification and Stability Considerations of Packaging Qualification Develop the Packaging Process and Perform an Operational Qualification of Equipment, Processing and Machinery xiii

10 Healthcare Sterilisation: Challenging Practices Volume Process Qualification Evaluation Packaging System Design Validation Pharmaceutical Packaging Tests Stability of Packaging Packaging for Different Sterilisation Techniques Packaging for Moist Heat Factors to Consider when Designing Tests to Determine Moist Heat Material Compatibility Loading the Steriliser Packaging for Dry Heat Packaging for Ethylene Oxide Sterilisation Packaging Materials Packaging for Radiation Sterilisation Packaging for Hydrogen Peroxide (with and without Plasma) Packaging for Ozone Sterilisation Chlorine Dioxide Liquid Sterilants Sterilisation of Containers and Packages with Liquids and Cycles with Differential Pressure Control The Need for Pressure Control Heating Sterilisation Cooling Types of Package Rigid Packages Semi-rigid Containers or Packages Soft Containers or Packages Temperature Control Steam Air Mix within Package xiv

11 Contents The Partial Pressure in a Mixture of Steam and Air Examples - Mix of Air and Steam Leaving Instruments Unpackaged for Sterilisation Re-using Sterilisation Packaging Material Strength and Integrity of a Package Packaging Integrity Seal Strength Burst Package Integrity Some Microbial Challenge/Product Sterility Test Methods Aerosol Challenge Dust/Talc Challenge Liquid Immersion Physical Test Methods Visual Inspection Internal Pressure Test Vacuum Leak Test Dye Penetration Test Gas Sensing Test Method Sterile Packaging Storage Transportation of Sterile Items Aseptic Packaging Purpose of Aseptic Sterile Packaging Guidance on Aseptic Sterile Packaging Sterile Packaging for Hospitals Some Sources of Failure Opening of Packages Asepsis and Identification Future of Sterile Packaging xv

12 Healthcare Sterilisation: Challenging Practices Volume Safety, Reusability, Waste and Disposal Waste Strategies Source Reduction of Unnecessary Waste Use of Reusable Packaging Other Waste Strategies Statistics, Standards and Validation Statistics Definition and Background Determination of Sterility Biological Indicators Product Sterility The Suitability and Qualification (Validation) of Sterility Testing of Product Kinetics of Microbial Inactivation Decimal Reduction Value Probability of Survivor (or Sterility Assurance Level) Design of a Sterilisation Process Biocompatibility Pre-qualification Selection of a Sterilisation Method A Simple Way to Design a Process Mathematically Pre-validation Product Qualification Other Methods of Microbiological Performance Qualification Bioburden Approach Survivor Curve Construction Fraction-Negative Approach The Stumbo-Murphy-Cochran Procedure The Overkill Approach or Method xvi

13 Contents In Review Sterilisation Validation Retrospective Validation Prospective Validation Concurrent Validation Revalidation A Total Approach toward Sterilisation Validation when a New Product, Polymer or Package is Required to be Sterilised Dry Heat Sterilisation Validation Dry Heat instead of Steam Sterilisation General Aspects of Dry Heat Sterilisation Validation Dry Heat Validation Plan Biovalidation Validation Steam and Ethylene Oxide Sterilisation Validation Steam Sterilisation Validation Ethylene Oxide Sterilisation Validation Radiation Validation Guidance Standards ANSI/AAMI/ISO , Sterilisation of Health Care Products - Radiation - Part 1: Requirements for Development, Validation and Routine Control of a Sterilisation Process for Medical Devices, ANSI/AAMI/ISO , Sterilisation of Health Care Products - Radiation Part 2: Establishing the Sterilisation Dose, Dosimetry Routine Dose Audits xvii

14 Healthcare Sterilisation: Challenging Practices Volume Conclusions and Future Considerations Hydrogen Peroxide, Ozone and New Sterilisation Agent or Process Selection of Micro-organisms Choosing a Sterility Assurance Level Liquid Sterilisation Supercritical (Fluid) Sterilisation Validation of Aseptic Processing Sterilisation and Statistics by Filtration Validation Statistics Sterilisation with Aseptic Processing Equipment and Components Qualification and Validation Equipment Controls and Instrument Calibration Environmental Monitoring General Written Programme Establishing Environmental Levels and a Trending Programme Disinfection Effectiveness Monitoring Methods Microbiological Media and Identification Particle Counting Closure Container - Packaging Integrity Preservation System Aseptic Processing from Other Steps in Manufacturing Some Revalidation, Qualification or Audit Drivers or Requirements Review and Future xviii

15 Contents Abbreviations Index xix

16 Healthcare Sterilisation: Challenging Practices Volume 2 xx

Healthcare Sterilisation: Introduction and Standard Practices, Volume 1

Healthcare Sterilisation: Introduction and Standard Practices, Volume 1 Contents 1. Overview of Sterilisation and Background... 1 1.1 Magic Wand... 1 1.1.1 Definition of Sterilisation... 2 1.1.2 Detectives or Forensic Scientists... 3 1.1.3 Idealised Process... 6 1.1.4 Lesser