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…mehr
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.
Tim Sandle is Head of Microbiology at the Bio Products Laboratory, Elstree, UK and a visiting tutor with the School of Pharmacy and Pharmaceutical Sciences, Manchester University, UK.
Inhaltsangabe
Dedication
List of figures and tables
Preface
About the author
Introduction
Chapter 1: Sterility, sterilisation and microorganisms
Abstract:
1.1 Introduction
1.2 Sterility
1.3 Sterility Assurance and the Sterility Assurance Level (SAL)
1.4 Sterility testing
1.5 Parametric release
1.6 Sterile products
1.7 Sterilisation
1.8 Factors affecting sterilisation
1.9 Risk assessment
1.10 Conclusion
Chapter 2: Pyrogenicity bacterial endotoxin
Abstract:
2.1 Introduction
2.2 Pyrogenicity
2.3 Endotoxin
2.4 The LAL test
2.5 Alternative assays
2.6 Water: the source of endotoxins in pharmaceutical manufacturing
2.7 Conclusion
Chapter 3: Regulatory requirements and Good Manufacturing Practices (GMP)
Abstract
3.1 Introduction
3.2 A brief history of compliance
3.3 Key terminology
3.4 Current regulatory requirements
3.5 Federal Drug Administration (FDA)
3.6 European Good Manufacturing Practices
3.7 Pharmaceutical Inspection Convention (PIC) and the Pharmaceutical Inspection Co-operation Scheme (PIC Scheme)
3.8 World Health Organisation
3.9 ISO
3.10 ICH
3.11 Pharmacopoeias
3.12 National standards
3.13 Other sources of guidance
3.14 Regulatory inspections
3.15 Conclusion
Chapter 4: Gamma radiation
Abstract:
4.1 Introduction
4.2 Application of gamma radiation
4.3 Sterilisation method
4.4 Process requirements
4.5 Regulatory aspects
4.6 Conclusion
Chapter 5: Electron beam processing
Abstract:
5.1 Introduction
5.2 Application of e-beam radiation
5.3 Sterilisation method
5.4 Microbial destruction
5.5 Process requirements
5.6 Advantages of e-beam radiation
5.7 Disadvantages of e-beam radiation
5.8 Conclusion
Chapter 6: Dry heat sterilisation
Abstract:
6.1 Introduction
6.2 Microbial kill and endotoxin inactivation
6.3 Application of dry heat sterilisation
6.4 Validation of dry heat devices
6.5 Advantages and disadvantages of dry heat sterilisation
6.6 Conclusion
Chapter 7: Steam sterilisation
Abstract:
7.1 Introduction
7.2 Microbial destruction
7.3 Steam sterilisation devices
7.4 Applications of steam sterilisation
7.5 Cycle development
7.6 Validation of steam sterilisation cycles
7.7 In-use evaluation
7.8 Flash sterilisation
7.9 Advantages and disadvantages of steam sterilisation