{"product_id":"sterility-sterilisation-and-sterility-assurance-for-pharmaceuticals-technology-validation-and-current-regulations-hardback-9781907568381","title":"Sterility, Sterilisation and Sterility Assurance for Pharmaceuticals; Technology, Validation and Current Regulations (Hardback) 9781907568381","description":"\u003cfont face=\"Georgia\"\u003e\r\n\u003cp\u003e\u003cfont size=\"6\"\u003eSterility, Sterilisation and Sterility Assurance for Pharmaceuticals\u003c\/font\u003e\u003cbr\u003e\r\n\u003cfont size=\"5\"\u003eTechnology, Validation and Current Regulations\u003c\/font\u003e\u003c\/p\u003e\r\n\r\n\r\n\r\n\r\n\u003cp\u003e\u003cfont size=\"4\"\u003eTim Sandle (Author)\u003c\/font\u003e\u003c\/p\u003e\r\n\r\n\u003cp\u003e\u003cfont size=\"3\"\u003e9781907568381, Elsevier Science\u003c\/font\u003e\u003c\/p\u003e\r\n\r\n\u003cp\u003e\u003cfont size=\"3\"\u003eHardback, published 31 October 2013\u003c\/font\u003e\u003c\/p\u003e\r\n\r\n\u003cp\u003e\u003cfont size=\"3\"\u003e362 pages\u003cbr\u003e23.3 x 15.6 x 2.5 cm, 0.69 kg\u003c\/font\u003e\u003c\/p\u003e\r\n\r\n\r\n\r\n\r\n\r\n\u003cp align=\"justify\"\u003e\u003cstrong\u003e\u003cfont size=\"3\"\u003eFailure 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.\u003c\/font\u003e\u003c\/strong\u003e\u003c\/p\u003e\r\n\r\n\u003cp\u003e\u003cfont size=\"3\"\u003e\u003cp\u003eDedication\u003c\/p\u003e \u003cp\u003eList of figures and tables\u003c\/p\u003e \u003cp\u003ePreface\u003c\/p\u003e \u003cp\u003eAbout the author\u003c\/p\u003e \u003cp\u003eIntroduction\u003c\/p\u003e \u003cp\u003eChapter 1: Sterility, sterilisation and microorganisms\u003c\/p\u003e \u003cp\u003eAbstract:\u003c\/p\u003e \u003cp\u003e1.1 Introduction\u003c\/p\u003e \u003cp\u003e1.2 Sterility\u003c\/p\u003e \u003cp\u003e1.3 Sterility Assurance and the Sterility Assurance Level (SAL)\u003c\/p\u003e \u003cp\u003e1.4 Sterility testing\u003c\/p\u003e \u003cp\u003e1.5 Parametric release\u003c\/p\u003e \u003cp\u003e1.6 Sterile products\u003c\/p\u003e \u003cp\u003e1.7 Sterilisation\u003c\/p\u003e \u003cp\u003e1.8 Factors affecting sterilisation\u003c\/p\u003e \u003cp\u003e1.9 Risk assessment\u003c\/p\u003e \u003cp\u003e1.10 Conclusion\u003c\/p\u003e \u003cp\u003eChapter 2: Pyrogenicity bacterial endotoxin\u003c\/p\u003e \u003cp\u003eAbstract:\u003c\/p\u003e \u003cp\u003e2.1 Introduction\u003c\/p\u003e \u003cp\u003e2.2 Pyrogenicity\u003c\/p\u003e \u003cp\u003e2.3 Endotoxin\u003c\/p\u003e \u003cp\u003e2.4 The LAL test\u003c\/p\u003e \u003cp\u003e2.5 Alternative assays\u003c\/p\u003e \u003cp\u003e2.6 Water: the source of endotoxins in pharmaceutical manufacturing\u003c\/p\u003e \u003cp\u003e2.7 Conclusion\u003c\/p\u003e \u003cp\u003eChapter 3: Regulatory requirements and Good Manufacturing Practices (GMP)\u003c\/p\u003e \u003cp\u003eAbstract\u003c\/p\u003e \u003cp\u003e3.1 Introduction\u003c\/p\u003e \u003cp\u003e3.2 A brief history of compliance\u003c\/p\u003e \u003cp\u003e3.3 Key terminology\u003c\/p\u003e \u003cp\u003e3.4 Current regulatory requirements\u003c\/p\u003e \u003cp\u003e3.5 Federal Drug Administration (FDA)\u003c\/p\u003e \u003cp\u003e3.6 European Good Manufacturing Practices\u003c\/p\u003e \u003cp\u003e3.7 Pharmaceutical Inspection Convention (PIC) and the Pharmaceutical Inspection Co-operation Scheme (PIC Scheme)\u003c\/p\u003e \u003cp\u003e3.8 World Health Organisation\u003c\/p\u003e \u003cp\u003e3.9 ISO\u003c\/p\u003e \u003cp\u003e3.10 ICH\u003c\/p\u003e \u003cp\u003e3.11 Pharmacopoeias\u003c\/p\u003e \u003cp\u003e3.12 National standards\u003c\/p\u003e \u003cp\u003e3.13 Other sources of guidance\u003c\/p\u003e \u003cp\u003e3.14 Regulatory inspections\u003c\/p\u003e \u003cp\u003e3.15 Conclusion\u003c\/p\u003e \u003cp\u003eChapter 4: Gamma radiation\u003c\/p\u003e \u003cp\u003eAbstract:\u003c\/p\u003e \u003cp\u003e4.1 Introduction\u003c\/p\u003e \u003cp\u003e4.2 Application of gamma radiation\u003c\/p\u003e \u003cp\u003e4.3 Sterilisation method\u003c\/p\u003e \u003cp\u003e4.4 Process requirements\u003c\/p\u003e \u003cp\u003e4.5 Regulatory aspects\u003c\/p\u003e \u003cp\u003e4.6 Conclusion\u003c\/p\u003e \u003cp\u003eChapter 5: Electron beam processing\u003c\/p\u003e \u003cp\u003eAbstract:\u003c\/p\u003e \u003cp\u003e5.1 Introduction\u003c\/p\u003e \u003cp\u003e5.2 Application of e-beam radiation\u003c\/p\u003e \u003cp\u003e5.3 Sterilisation method\u003c\/p\u003e \u003cp\u003e5.4 Microbial destruction\u003c\/p\u003e \u003cp\u003e5.5 Process requirements\u003c\/p\u003e \u003cp\u003e5.6 Advantages of e-beam radiation\u003c\/p\u003e \u003cp\u003e5.7 Disadvantages of e-beam radiation\u003c\/p\u003e \u003cp\u003e5.8 Conclusion\u003c\/p\u003e \u003cp\u003eChapter 6: Dry heat sterilisation\u003c\/p\u003e \u003cp\u003eAbstract:\u003c\/p\u003e \u003cp\u003e6.1 Introduction\u003c\/p\u003e \u003cp\u003e6.2 Microbial kill and endotoxin inactivation\u003c\/p\u003e \u003cp\u003e6.3 Application of dry heat sterilisation\u003c\/p\u003e \u003cp\u003e6.4 Validation of dry heat devices\u003c\/p\u003e \u003cp\u003e6.5 Advantages and disadvantages of dry heat sterilisation\u003c\/p\u003e \u003cp\u003e6.6 Conclusion\u003c\/p\u003e \u003cp\u003eChapter 7: Steam sterilisation\u003c\/p\u003e \u003cp\u003eAbstract:\u003c\/p\u003e \u003cp\u003e7.1 Introduction\u003c\/p\u003e \u003cp\u003e7.2 Microbial destruction\u003c\/p\u003e \u003cp\u003e7.3 Steam sterilisation devices\u003c\/p\u003e \u003cp\u003e7.4 Applications of steam sterilisation\u003c\/p\u003e \u003cp\u003e7.5 Cycle development\u003c\/p\u003e \u003cp\u003e7.6 Validation of steam sterilisation cycles\u003c\/p\u003e \u003cp\u003e7.7 In-use evaluation\u003c\/p\u003e \u003cp\u003e7.8 Flash sterilisation\u003c\/p\u003e \u003cp\u003e7.9 Advantages and disadvantages of steam sterilisation\u003c\/p\u003e \u003cp\u003e7.10 Conclusion\u003c\/p\u003e \u003cp\u003eChapter 8: Gaseous sterilisation\u003c\/p\u003e \u003cp\u003eAbstract:\u003c\/p\u003e \u003cp\u003e8.1 Introduction\u003c\/p\u003e \u003cp\u003e8.2 Applications\u003c\/p\u003e \u003cp\u003e8.3 Ethylene oxide\u003c\/p\u003e \u003cp\u003e8.4 Ozone\u003c\/p\u003e \u003cp\u003e8.5 Chlorine dioxide gas\u003c\/p\u003e \u003cp\u003e8.6 Summary\u003c\/p\u003e \u003cp\u003eChapter 9: Hydrogen peroxide vapour sterilisation\u003c\/p\u003e \u003cp\u003eAbstract:\u003c\/p\u003e \u003cp\u003e9.1 Introduction\u003c\/p\u003e \u003cp\u003e9.2 Chemical composition\u003c\/p\u003e \u003cp\u003e9.3 Antimicrobial effectiveness\u003c\/p\u003e \u003cp\u003e9.4 Barrier devices and isolators\u003c\/p\u003e \u003cp\u003e9.5 HVP cycles\u003c\/p\u003e \u003cp\u003e9.6 Validating VHP cycles\u003c\/p\u003e \u003cp\u003e9.7 Cycle failures\u003c\/p\u003e \u003cp\u003e9.8 Conclusion\u003c\/p\u003e \u003cp\u003eChapter 10: Sterilisation by filtration\u003c\/p\u003e \u003cp\u003eAbstract:\u003c\/p\u003e \u003cp\u003e10.1 Introduction\u003c\/p\u003e \u003cp\u003e10.2 Sterilising grade filters\u003c\/p\u003e \u003cp\u003e10.3 Application of sterilising grade filters\u003c\/p\u003e \u003cp\u003e10.4 Filter testing\u003c\/p\u003e \u003cp\u003e10.5 Filter failures\u003c\/p\u003e \u003cp\u003e10.6 Selection of sterilising grade filters\u003c\/p\u003e \u003cp\u003e10.7 Validation of sterilising grade filters\u003c\/p\u003e \u003cp\u003e10.8 Conclusion\u003c\/p\u003e \u003cp\u003eChapter 11: Other methods of sterilisation\u003c\/p\u003e \u003cp\u003eAbstract:\u003c\/p\u003e \u003cp\u003e11.1 Introduction\u003c\/p\u003e \u003cp\u003e11.2 Ultraviolet light\u003c\/p\u003e \u003cp\u003e11.3 Pulsed light\u003c\/p\u003e \u003cp\u003e11.4 Microwaves\u003c\/p\u003e \u003cp\u003e11.5 Infrared radiation\u003c\/p\u003e \u003cp\u003e11.6 Ultrasonics\u003c\/p\u003e \u003cp\u003e11.7 Supercritical gases\u003c\/p\u003e \u003cp\u003e11.8 Formaldehyde steam\u003c\/p\u003e \u003cp\u003e11.9 X-rays\u003c\/p\u003e \u003cp\u003e11.10 Plasma\u003c\/p\u003e \u003cp\u003e11.11 Nitrogen dioxide\u003c\/p\u003e \u003cp\u003e11.12 Non-sterilising processes\u003c\/p\u003e \u003cp\u003e11.13 Conclusion\u003c\/p\u003e \u003cp\u003eChapter 12: Depyrogenation and endotoxin\u003c\/p\u003e \u003cp\u003eAbstract:\u003c\/p\u003e \u003cp\u003e12.1 Introduction\u003c\/p\u003e \u003cp\u003e12.2 Different types of depyrogenation\u003c\/p\u003e \u003cp\u003e12.3 Case study 1: Dry heat depyrogenation\u003c\/p\u003e \u003cp\u003e12.4 Case study 2: Removal of endotoxin through rinsing\u003c\/p\u003e \u003cp\u003e12.5 Conclusion\u003c\/p\u003e \u003cp\u003eChapter 13: Cleanrooms, isolators and cleanroom technology\u003c\/p\u003e \u003cp\u003eAbstract:\u003c\/p\u003e \u003cp\u003e13.1 Introduction\u003c\/p\u003e \u003cp\u003e13.2 Cleanrooms and contamination control\u003c\/p\u003e \u003cp\u003e13.3 Cleanroom classification\u003c\/p\u003e \u003cp\u003e13.4 Cleanroom operating conditions\u003c\/p\u003e \u003cp\u003e13.5 Measuring the physical operation of cleanrooms\u003c\/p\u003e \u003cp\u003e13.6 Clean air devices and isolators\u003c\/p\u003e \u003cp\u003e13.7 Ongoing monitoring\u003c\/p\u003e \u003cp\u003e13.8 Conclusion\u003c\/p\u003e \u003cp\u003eChapter 14: Aseptic processing filling\u003c\/p\u003e \u003cp\u003eAbstract:\u003c\/p\u003e \u003cp\u003e14.1 Introduction\u003c\/p\u003e \u003cp\u003e14.2 Selecting aseptic manufacture in place of terminal sterilisation\u003c\/p\u003e \u003cp\u003e14.3 Regulatory aspects\u003c\/p\u003e \u003cp\u003e14.4 Aseptic processing risks and sources of contamination\u003c\/p\u003e \u003cp\u003e14.5 Contamination control\u003c\/p\u003e \u003cp\u003e14.6 Types of aseptic filling\u003c\/p\u003e \u003cp\u003e14.7 Single-use sterile disposable items\u003c\/p\u003e \u003cp\u003e14.8 Conclusion\u003c\/p\u003e \u003cp\u003eChapter 15: Media simulation trials\u003c\/p\u003e \u003cp\u003eAbstract:\u003c\/p\u003e \u003cp\u003e15.1 Introduction\u003c\/p\u003e \u003cp\u003e15.2 Defining a media simulation trial\u003c\/p\u003e \u003cp\u003e15.3 Objectives of a media simulation trial\u003c\/p\u003e \u003cp\u003e15.4 The media trial protocol\u003c\/p\u003e \u003cp\u003e15.5 Conducting media simulation trials\u003c\/p\u003e \u003cp\u003e15.6 Frequency of media simulation trials\u003c\/p\u003e \u003cp\u003e15.7 Media fill failures\u003c\/p\u003e \u003cp\u003e15.8 Media fill invalidation\u003c\/p\u003e \u003cp\u003e15.9 Conclusion\u003c\/p\u003e \u003cp\u003eChapter 16: Cleaning disinfection of sterile processing facilities\u003c\/p\u003e \u003cp\u003eAbstract:\u003c\/p\u003e \u003cp\u003e16.1 Introduction\u003c\/p\u003e \u003cp\u003e16.2 Cleaning\u003c\/p\u003e \u003cp\u003e16.3 Disinfection\u003c\/p\u003e \u003cp\u003e16.3.3 Factors affecting disinfectant efficacy\u003c\/p\u003e \u003cp\u003e16.4 Cleaning and disinfection in practice\u003c\/p\u003e \u003cp\u003e16.5 Environmental monitoring\u003c\/p\u003e \u003cp\u003e16.6 Validation of disinfectants\u003c\/p\u003e \u003cp\u003e16.7 Conclusion\u003c\/p\u003e \u003cp\u003eChapter 17: Biological indicators\u003c\/p\u003e \u003cp\u003eAbstract:\u003c\/p\u003e \u003cp\u003e17.1 Introduction\u003c\/p\u003e \u003cp\u003e17.2 Application of biological indicators\u003c\/p\u003e \u003cp\u003e17.3 Characteristics of biological indicators\u003c\/p\u003e \u003cp\u003e17.4 Use of biological indicators\u003c\/p\u003e \u003cp\u003e17.5 Areas of concern and testing errors\u003c\/p\u003e \u003cp\u003e17.6 Conclusion\u003c\/p\u003e \u003cp\u003eChapter 18: The Sterility Test\u003c\/p\u003e \u003cp\u003eAbstract:\u003c\/p\u003e \u003cp\u003e18.1 Introduction\u003c\/p\u003e \u003cp\u003e18.2 Sterility Test methods\u003c\/p\u003e \u003cp\u003e18.3 Pharmacopeia Sterility Test\u003c\/p\u003e \u003cp\u003e18.4 Test environment\u003c\/p\u003e \u003cp\u003e18.5 Sterility Test media\u003c\/p\u003e \u003cp\u003e18.6 Sterility Test method validation\u003c\/p\u003e \u003cp\u003e18.7 Stasis Test\u003c\/p\u003e \u003cp\u003e18.8 GMP requirements\u003c\/p\u003e \u003cp\u003e18.9 Can the Sterility Test really confirm product sterility?\u003c\/p\u003e \u003cp\u003e18.10 Rapid microbiological methods\u003c\/p\u003e \u003cp\u003e18.11 Conclusion\u003c\/p\u003e \u003cp\u003eChapter 19: Investigating sterility test failures\u003c\/p\u003e \u003cp\u003eAbstract:\u003c\/p\u003e \u003cp\u003e19.1 Introduction\u003c\/p\u003e \u003cp\u003e19.2 Failure investigations\u003c\/p\u003e \u003cp\u003e19.3 Sterility Test and process area link\u003c\/p\u003e \u003cp\u003e19.4 Re-testing\u003c\/p\u003e \u003cp\u003e19.5 Concluding Sterility Test failure investigations\u003c\/p\u003e \u003cp\u003e19.6 Conclusion\u003c\/p\u003e \u003cp\u003eChapter 20: Auditing sterilisation processes facilities\u003c\/p\u003e \u003cp\u003eAbstract:\u003c\/p\u003e \u003cp\u003e20.1 Introduction\u003c\/p\u003e \u003cp\u003e20.2 The audit process\u003c\/p\u003e \u003cp\u003e20.3 Scope of audits\u003c\/p\u003e \u003cp\u003e20.4 Key focal points for auditing sterile manufacturing facilities\u003c\/p\u003e \u003cp\u003e20.5 Conclusion\u003c\/p\u003e \u003cp\u003eConclusion\u003c\/p\u003e \u003cp\u003eIndex\u003c\/p\u003e\u003c\/font\u003e\u003c\/p\u003e\r\n\r\n\u003cp\u003e\u003cfont size=\"3\"\u003eSubject Areas: Pharmacy \/ dispensing [\u003ca title=\"See our other books on Pharmacy \/ dispensing\" href=\"https:\/\/freshlyprintedbooks.co.uk\/search?q=%22Pharmacy%20\/%20dispensing%20%5BMQP%5D%22\"\u003eMQP\u003c\/a\u003e]\u003c\/font\u003e\u003c\/p\u003e\r\n\r\n\r\n\u003c\/font\u003e","brand":"Woodhead Publishing","offers":[{"title":"Default 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