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    1. Ekonomi och Ledarskap
    2. Ledarskapsböcker
    3. Projektledning

    Pharmaceutical Microbiology

    Essentials for Quality Assurance and Quality Control

    AvTim Sandle

    Inbunden, Engelska, 2027

    Del i serien Woodhead Publishing Series in Biomedicine

    2 311 kr

    Kommande

    Fler format och utgåvor

    Inbunden

    1 996 kr

    E-bok

    2 219 kr

    Beskrivning

    The second edition of Pharmaceutical Microbiology: Essentials for Quality Assurance and Quality Control is an authoritative reference designed for pharmaceutical microbiologists, sterilization personnel, and production scientists. It addresses the evolving landscape of microbiological standards, regulatory requirements, and scientific innovations in the pharmaceutical industry. The book emphasizes the importance of maintaining compliance through updated practices, new testing methodologies, and comprehensive contamination control strategies, ensuring safety and quality in pharmaceutical manufacturing.

    This book provides invaluable insights for professionals seeking to optimize microbiological quality assurance, meet regulatory expectations, and adopt innovative technologies. It supports laboratory managers, microbiologists, and quality assurance specialists in implementing best practices, ensuring product safety, and staying abreast of scientific progress in pharmaceutical microbiology.

    • Updates regulations, standards, and scientific advancements in pharmaceutical microbiology
    • Introduces new chapters on cell culture, biocontamination control, and beneficial microorganism uses
    • Expands on rapid microbiological methods, water system assessment, and container closure integrity
    • Reflects recent developments in GMP, endotoxin testing, and sterilization technologies
    • Provides comprehensive guidance for microbiology laboratories and quality assurance

    Produktinformation

    • Utgivningsdatum:2027-03-01
    • Mått:152 x 229 x undefined mm
    • Format:Inbunden
    • Språk:Engelska
    • Serie:Woodhead Publishing Series in Biomedicine
    • Antal sidor:400
    • Upplaga:2
    • Förlag:Elsevier Science
    • ISBN:9780443491993

    Utforska kategorier

    • Projektledning inom Ekonomi och Ledarskap
    • Apotek och farmaceuter inom Medicin
    • Biologi inom Naturvetenskap och teknik

    Mer om författaren

    Dr. Sandle is a chartered biologist and holds a first class honours degree in Applied Biology; a Masters degree in education; and has a doctorate from Keele University.He has over twenty-five years experience of microbiological research, quality assurance, and biopharmaceutical processing. This includes experience of designing, validating and operating a range of microbiological tests including sterility testing, bacterial endotoxin testing, bioburden and microbial enumeration, environmental monitoring, particle counting and water testing. In addition, Dr. Sandle is experienced in quality risk assessment, root cause analysis, and investigation.Dr. Sandle is a tutor with the School of Pharmacy and Pharmaceutical Sciences, University of Manchester for the university’s pharmaceutical microbiology MSc course, and at University College, London. In addition, Dr. Sandle has served on several national and international committees relating to pharmaceutical microbiology and cleanroom contamination control (including the ISO cleanroom standards and the National Blood Service advisory cleaning and disinfection committee).

    Innehållsförteckning

    • 1. Introduction to pharmaceutical microbiology2. Microbiology and pharmaceuticals3. GMP and regulations4. Laboratory management and design5. Microbiological culture media6. Microbiology laboratory techniques7. Bioburden determination8. Specified and objectionable microorganisms9. Microbial identification10. Assessment of pharmaceutical water systems11. Endotoxin and pyrogen testing12. Sterilization and sterility assurance13. Biological and enzymatic indicators: Measuring sterilization14. Maintaining sterility: Container closure integrity15. Antibiotics and preservatives16. Cleaning and disinfection17. Cleanrooms and environmental monitoring18. Particle counting: Conventional and spectrophotometric19. Biocontamination control strategies20. Rapid microbiological methods21. Risk assessment and microbiology22. Manufacturing and validation23. Beneficial uses of microorganisms: Biofermentation and beyond24. Cell culture, mycoplasma, and virus testing25. Microbiological data