Sterility, Sterilisation And Sterility Assurance For Pharmaceuticals : Technology, Validation And Current Regulations.

Format:

Book

Author/Creator:

Sandle, T.

Contributor:

ScienceDirect (Online service)

Series:

Woodhead Publishing series in biomedicine

Woodhead Publishing Series in Biomedicine

Language:

English

Subjects (All):

Sterilization.

Polymers in medicine--Sterilization.

Local Subjects:

Polymers in medicine--Sterilization.

Sterilization.

Genre:

Electronic books.

Physical Description:

1 online resource (370 pages).

polychrome

Place of Publication:

Burlington : Elsevier Science, 2013.

System Details:

text file

Summary:

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:

Cover; Sterility, sterilisation and sterility assurance for pharmaceuticals: Technology, validation andcurrent regulations; Copyright; Dedication; Contents; List of figures and tables; Preface; About the author; Introduction; I.1 References; 1 Sterility, sterilisation and microorganisms; 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; 1.11 References.

2 Pyrogenicity and bacterial endotoxin2.1 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; 2.8 Note; 2.9 References; 3 Regulatory requirements and Good Manufacturing Practices (GMP); 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 Cooperation 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; 3.16 References; 4 Gamma radiation; 4.1 Introduction; 4.2 Application of gamma radiation; 4.3 Sterilisation method; 4.4 Process requirements; 4.5 Regulatory aspects; 4.6 Conclusion; 4.7 References; 5 Electron beam processing; 5.1 Introduction; 5.2 Application of ebeam radiation; 5.3 Sterilisation method.

5.4 Microbial destruction5.5 Process requirements; 5.6 Advantages of ebeam radiation; 5.7 Disadvantages of ebeam radiation; 5.8 Conclusion; 5.9 References; 6 Dry heat sterilisation; 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; 6.7 References; 7 Steam sterilisation; 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 cycles7.7 Inuse evaluation; 7.8 Flash sterilisation; 7.9 Advantages and disadvantages of steam sterilisation; 7.10 Conclusion; 7.11 References; 8 Gaseous sterilisation; 8.1 Introduction; 8.2 Applications; 8.3 Ethylene oxide; 8.4 Ozone; 8.5 Chlorine dioxide gas; 8.6 Summary; 8.7 Notes; 8.8 References; 9 Hydrogen peroxide vapour sterilisation; 9.1 Introduction; 9.2 Chemical composition; 9.3 Antimicrobial effectiveness; 9.4 Barrier devices and isolators; 9.5 HVP cycles; 9.6 Validating VHP cycles; 9.7 Cycle failures; 9.8 Conclusion; 9.9 References.

10 Sterilisation by filtration.

Notes:

Description based on print version record.

Other Format:

Print version: Sandle, T. Sterility, Sterilisation And Sterility Assurance For Pharmaceuticals : Technology, Validation And Current Regulations.

ISBN:

9781908818638

1908818638

OCLC:

865332776

Access Restriction:

Restricted for use by site license.