Full Description
Failure to adequately control any microbial challenge associated within process or product by robust sterilisation will result in a contaminated marketed product, with potential harm to the patient. Sterilisation is therefore of great importance to healthcare and the manufacturers of medical devices and pharmaceuticals. Sterility, sterilisation and sterility assurance for pharmaceuticals examines different means of rendering a product sterile by providing an overview of sterilisation methods including heat, radiation and filtration. The book outlines and discusses sterilisation technology and the biopharmaceutical manufacturing process, including aseptic filling, as well as aspects of the design of containers and packaging, as well as addressing the cleanroom environments in which products are prepared. Consisting of 18 chapters, the book comprehensively covers sterility, sterilisation and microorganisms; pyrogenicity and bacterial endotoxins; regulatory requirements and good manufacturing practices; and gamma radiation. Later chapters discuss e-beam; dry heat sterilisation; steam sterilisation; sterilisation by gas; vapour sterilisation; and sterile filtration, before final chapters analyse depyrogenation; cleanrooms; aseptic processing; media simulation; biological indicators; sterility testing; auditing; and new sterilisation techniques.
Contents
DedicationList of figures and tablesPrefaceAbout the authorIntroductionChapter 1: Sterility, sterilisation and microorganismsAbstract:1.1 Introduction1.2 Sterility1.3 Sterility Assurance and the Sterility Assurance Level (SAL)1.4 Sterility testing1.5 Parametric release1.6 Sterile products1.7 Sterilisation1.8 Factors affecting sterilisation1.9 Risk assessment1.10 ConclusionChapter 2: Pyrogenicity bacterial endotoxinAbstract:2.1 Introduction2.2 Pyrogenicity2.3 Endotoxin2.4 The LAL test2.5 Alternative assays2.6 Water: the source of endotoxins in pharmaceutical manufacturing2.7 ConclusionChapter 3: Regulatory requirements and Good Manufacturing Practices (GMP)Abstract3.1 Introduction3.2 A brief history of compliance3.3 Key terminology3.4 Current regulatory requirements3.5 Federal Drug Administration (FDA)3.6 European Good Manufacturing Practices3.7 Pharmaceutical Inspection Convention (PIC) and the Pharmaceutical Inspection Co-operation Scheme (PIC Scheme)3.8 World Health Organisation3.9 ISO3.10 ICH3.11 Pharmacopoeias3.12 National standards3.13 Other sources of guidance3.14 Regulatory inspections3.15 ConclusionChapter 4: Gamma radiationAbstract:4.1 Introduction4.2 Application of gamma radiation4.3 Sterilisation method4.4 Process requirements4.5 Regulatory aspects4.6 ConclusionChapter 5: Electron beam processingAbstract:5.1 Introduction5.2 Application of e-beam radiation5.3 Sterilisation method5.4 Microbial destruction5.5 Process requirements5.6 Advantages of e-beam radiation5.7 Disadvantages of e-beam radiation5.8 ConclusionChapter 6: Dry heat sterilisationAbstract:6.1 Introduction6.2 Microbial kill and endotoxin inactivation6.3 Application of dry heat sterilisation6.4 Validation of dry heat devices6.5 Advantages and disadvantages of dry heat sterilisation6.6 ConclusionChapter 7: Steam sterilisationAbstract:7.1 Introduction7.2 Microbial destruction7.3 Steam sterilisation devices7.4 Applications of steam sterilisation7.5 Cycle development7.6 Validation of steam sterilisation cycles7.7 In-use evaluation7.8 Flash sterilisation7.9 Advantages and disadvantages of steam sterilisation7.10 ConclusionChapter 8: Gaseous sterilisationAbstract:8.1 Introduction8.2 Applications8.3 Ethylene oxide8.4 Ozone8.5 Chlorine dioxide gas8.6 SummaryChapter 9: Hydrogen peroxide vapour sterilisationAbstract:9.1 Introduction9.2 Chemical composition9.3 Antimicrobial effectiveness9.4 Barrier devices and isolators9.5 HVP cycles9.6 Validating VHP cycles9.7 Cycle failures9.8 ConclusionChapter 10: Sterilisation by filtrationAbstract:10.1 Introduction10.2 Sterilising grade filters10.3 Application of sterilising grade filters10.4 Filter testing10.5 Filter failures10.6 Selection of sterilising grade filters10.7 Validation of sterilising grade filters10.8 ConclusionChapter 11: Other methods of sterilisationAbstract:11.1 Introduction11.2 Ultraviolet light11.3 Pulsed light11.4 Microwaves11.5 Infrared radiation11.6 Ultrasonics11.7 Supercritical gases11.8 Formaldehyde steam11.9 X-rays11.10 Plasma11.11 Nitrogen dioxide11.12 Non-sterilising processes11.13 ConclusionChapter 12: Depyrogenation and endotoxinAbstract:12.1 Introduction12.2 Different types of depyrogenation12.3 Case study 1: Dry heat depyrogenation12.4 Case study 2: Removal of endotoxin through rinsing12.5 ConclusionChapter 13: Cleanrooms, isolators and cleanroom technologyAbstract:13.1 Introduction13.2 Cleanrooms and contamination control13.3 Cleanroom classification13.4 Cleanroom operating conditions13.5 Measuring the physical operation of cleanrooms13.6 Clean air devices and isolators13.7 Ongoing monitoring13.8 ConclusionChapter 14: Aseptic processing fillingAbstract:14.1 Introduction14.2 Selecting aseptic manufacture in place of terminal sterilisation14.3 Regulatory aspects14.4 Aseptic processing risks and sources of contamination14.5 Contamination control14.6 Types of aseptic filling14.7 Single-use sterile disposable items14.8 ConclusionChapter 15: Media simulation trialsAbstract:15.1 Introduction15.2 Defining a media simulation trial15.3 Objectives of a media simulation trial15.4 The media trial protocol15.5 Conducting media simulation trials15.6 Frequency of media simulation trials15.7 Media fill failures15.8 Media fill invalidation15.9 ConclusionChapter 16: Cleaning disinfection of sterile processing facilitiesAbstract:16.1 Introduction16.2 Cleaning16.3 Disinfection16.3.3 Factors affecting disinfectant efficacy16.4 Cleaning and disinfection in practice16.5 Environmental monitoring16.6 Validation of disinfectants16.7 ConclusionChapter 17: Biological indicatorsAbstract:17.1 Introduction17.2 Application of biological indicators17.3 Characteristics of biological indicators17.4 Use of biological indicators17.5 Areas of concern and testing errors17.6 ConclusionChapter 18: The Sterility TestAbstract:18.1 Introduction18.2 Sterility Test methods18.3 Pharmacopeia Sterility Test18.4 Test environment18.5 Sterility Test media18.6 Sterility Test method validation18.7 Stasis Test18.8 GMP requirements18.9 Can the Sterility Test really confirm product sterility?18.10 Rapid microbiological methods18.11 ConclusionChapter 19: Investigating sterility test failuresAbstract:19.1 Introduction19.2 Failure investigations19.3 Sterility Test and process area link19.4 Re-testing19.5 Concluding Sterility Test failure investigations19.6 ConclusionChapter 20: Auditing sterilisation processes facilitiesAbstract:20.1 Introduction20.2 The audit process20.3 Scope of audits20.4 Key focal points for auditing sterile manufacturing facilities20.5 ConclusionConclusionIndex
