Healthcare Sterilisation: Introduction and Standard Practices, Volume 1

Size: px

Start display at page:

Download "Healthcare Sterilisation: Introduction and Standard Practices, Volume 1"

Cuthbert Stevens
5 years ago
Views:

1 Contents 1. Overview of Sterilisation and Background Magic Wand Definition of Sterilisation Detectives or Forensic Scientists Idealised Process Lesser Degrees, Forms and Shapes of Sterilisation Sterilisation - Absolute State versus Probability Sterilisation: Applied and Determined by Different Means Decimal Reduction or Death Value Biological Indicator Process Challenge Device Different Sterility Methods Sterilisation Validation Dead or Viable (Micro) Organisms Sterilisation or Not? Sterilants Complications with Sterilisation Agents Limitations A Special Process Sterilisation May be More than Just Beliefs Complex or Simple Sterilisation Procedures and Compatibility When is Sterilisation Required? v

2 Healthcare Sterilisation: Introduction and Standard Practices, Volume Criticality Overview Some Newer Sterilisation Processes High-level Disinfectants Radiation Penetration Toxic Residuals Discontinued or Discharged Method(s) Some Effective and Traditional Methods Prions - Decontamination and Sterilisation Alternative and Modified Traditional Methods Further Work Healthcare Product Combinations Dry Heat Re-examined Steam Sterilisation - Another Option X-Rays Sterilisation and War Reliability Control Further Outlook Background to Sterlisation An Historical Introduction Glossary, Definitions and Terms Description Terminology (Definitions) Biocontainment (Environmental) Control and Microbiology Microbes are Everywhere Morphology/Shapes Barriers to Microbes for Sterilisation Ranking of Organisms Sterilisation Begins with Environmental Control vi

3 Contents Where are Microbes Found? Environmental Precautions Factors to Consider and Control Controlled Clean Room Areas Some Practical Considerations for Biocontainment Some Environmental Standards to be Considered for Biocontainment ISO : Cleanrooms and Associated Controlled Environments - Biocontamination Control - Part 1: General Principles and Methods, ISO : Cleanrooms and Associated Controlled Environments - Biocontamination Control - Part 2: Evaluation and Interpretation of Biocontamination Data, ISO : Cleanrooms and Associated Controlled Environments - Biocontamination Control Part - 3: Measurement of The Efficiency of Processes of Cleaning and/or Disinfection of Inert Surfaces Bearing Biocontaminated Wet Soiling or Biofilms, ISO : Cleanrooms and Associated Controlled Environments - Part 1: Classification of Air Cleanliness, ISO : Cleanrooms and Associated Controlled Environments - Part 2: Specification for Testing and Monitoring to Prove Compliance with ISO , ISO : Cleanrooms and Associated Controlled Environments - Part 3: Test Methods, ISO : Cleanrooms and Associated Controlled Environments - Part 4: Design and Construction and Start-up, ISO : Cleanrooms and Associated Controlled Environments - Part 5: Operations, ISO : Cleanrooms and Associated Controlled Environments - Part 7: Separative Devices (Clean Air Hoods, Glove Boxes, Isolators and Mini-Environments), vii

4 Healthcare Sterilisation: Introduction and Standard Practices, Volume ISO : Cleanrooms and Associated Controlled Environments - Part 8: Classification of Airborne Molecular Contamination, Monitor and Know (Your) Bioburden Sterilisation Processes Pyrogens and Endotoxins Control Quality and Quantity Bioburden Variations Unfavourable Variations Preventing Nosocomial Infections Environmentally Resistant Microbes Cleaning versus Disinfection Cleaning Disinfection Know the Microbes and their Environment Complete or Incomplete Recovery Microbial Effectiveness or Sterility Assurance Level Some Factors Influencing Microbial Inactivation Classical (Earlier) Sterilisation Principles and Methods Sterilisation Principles Sterility Beyond the Classical Sterility Test Sterilisation as a Classical Process Logarithmic or Exponential Form of Death Logarithmic versus Non-logarithmic Variation and the Order of Death Activation Clumped (or Flocculated) Cell Suspension Heterogeneity Nature of Recovery viii

5 Contents Nature of the Test Equipment Internal Surface Sterilisation Tailing Repair Mutations Sterilisation is a Special Process The D-Value Some Variations in the D-Value Classical Monitoring of Sterilisation Monitors for Sterilisation Process Biological Monitors Dosimetric, Parametric Release or Process Control Rapid Biological Indicator Release Some Misconceptions, Mysteries and Omissions Classical Sterilisation Methods Heat Sterilisation Steam (Moist Heat) Sterilisation Alternative Classical Heating Mechanisms Some Current Considerations Dry Heat Sterilisation/Depyrogenation Chemical Sterilisation including Ethylene Oxide Formaldehyde Ethylene Oxide Sterilisation by Filtration Radiation Sterilisation Advantages of using Ionising Irradiation Ozone Other Gases and Vapours β-propiolactone Propylene Oxide ix

6 Healthcare Sterilisation: Introduction and Standard Practices, Volume Methyl Bromide Some Ancient Chemical Sterilants Investigated Sterilants Liquid Sterilisation Liquid Sterilant - Formaldehyde Liquid Sterilant - Glutaraldehyde Liquid Sterilant - β-propiolactone Liquid Sterilant Diethyl Pyrocarbonate Liquid Sterilant - Iodine Ozone Alcohols with Additives Hydrogen Peroxide Chlorine Aseptic Process Aseptic Assembly Before Ethylene Oxide, Glutaraldehyde and Irradiation Conclusions Traditional and Moist Heat Sterilisation Introduction Moist Heat Sterilisation Advantages Sterilisation of Liquids Sterilisation of Various Products Decontamination, Microbiology, Cycle Parameters, and Types of Steam Sterilisation Processes Cycle Parameters Types of Steam Sterilisation Processes Sterilisation of Plastics, Polymers and Other Materials Different Modes of Moist Heat (Steam) Sterilisation x

7 Contents Disadvantages of Using Moist Heat Moist Heat Microbial Inactivation Factors Affecting Lethality Relative Humidity or Water Temperature Exposure or Contact with Moist Heat Varies End of Cycle Heat-up and Cool-down or Evacuation Phase Drying Heat and Moist Heat Stable Materials Drying Wet Products Typical Process Sequences for Moist Heat Sterilisation Drying (Whenever Needed) Achieving Successful Sterilisation Specialised Processing Sterilisation of Drugs Sterilisation of Biologics Facing Awesome Biological Challenges Head On Prions Magic Sterilisation of Prions Facing Environmental (Green) Challenges Head On Some Final Considerations In Conclusion - Why Use Moist Heat Sterilisation? The Future of Moist Heat Sterilisation Dry Heat Sterilisation/Depyrogenation Dry Heat Processing Process Equipment xi

8 Healthcare Sterilisation: Introduction and Standard Practices, Volume Convection Heat Ovens Infrared Radiation Rapid Heat Transfer Steriliser Continuous Belt Sterilisers or Radiant Heat Tunnels Miscellaneous Characteristics Typical Products, Polymers, and Materials that can be Dry Heat Sterilised Potential Inactivation Mechanisms of Dry Heat Sterilisation Factors Affecting Lethality and Demonstrating Effectiveness Some Principle Advantages of Dry Heat Disadvantages of Dry Heat Typical Recommended Uses Enhancements and Improvements Materials and Device Construction - Compatibility for Dry Heat Packaging - Material and Device Construction Compatibility Materials for Product Construction Some Process Improvement Considerations Conclusions Radiation Sterilisation Properties of Ionising Radiation Processes Advantages of Using Ionising Irradiation Disadvantages and Reasons for Not Using Irradiation Radiation Ionising Sources Electron Beam Irradiation Radiation Sterilising Doses Lethality by Irradiation Material Compatibility by Irradiation [11] xii

9 Contents Thermoplastics Thermosets Elastomers Adhesives Metals Glass and Ceramics Liquids Biological Materials Packaging Typical Gamma Radiation Facility, Equipment and Product Handling Conveyor System and Equipment Typical Electron Beam Equipment and Systems Some Further Evolution of Electron Beam Systems Critical Information New Generation of Electron Beam Processing X-Ray Sterilisation (Decontamination or Sanitisation) Conclusions Abbreviations Index xiii

10 Healthcare Sterilisation: Introduction and Standard Practices, Volume 1 xiv

Healthcare Sterilisation: Challenging Practices Volume 2

Healthcare Sterilisation: Challenging Practices Volume 2 Contents 1 Traditional Chemical Sterilisation Methods... 1 1.1 Ethylene Oxide Sterilisation... 3 1.1.1 Green sterilisation (Benefits versus Risks)... 4 1.1.2 Ethylene Oxide Residuals... 8 1.1.3 Advantages