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Produktbild: Biocontamination Control for Pharmaceuticals and Healthcare

Biocontamination Control for Pharmaceuticals and Healthcare

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Beschreibung

Biocontamination Control for Pharmaceuticals and Healthcare, Second Edition outlines a biocontamination strategy that tracks bio-burden control and reduction at each transition in classified areas of a facility. The first edition of the book covers many of the aspects of the strategy, but the new official...

Beschreibung

Biocontamination Control for Pharmaceuticals and Healthcare, Second Edition outlines a biocontamination strategy that tracks bio-burden control and reduction at each transition in classified areas of a facility. The first edition of the book covers many of the aspects of the strategy, but the new official guidance signals that a roadmap is required to fully comply with its requirements. Completely updated with the newest version of the EU-GPM (EN17141), this new edition expands coverage of quality risk management and contains completely new examples to help professionals bridge the gap between regulation and implementation.
This book offers professionals in pharma quality control and related areas guidance on building a complete biocontamination strategy.

Produktdetails

Einband

Taschenbuch

Erscheinungsdatum

16.02.2024

Verlag Elsevier Science & Technology
Seitenzahl

508

Produktdetails

Einband

Taschenbuch

Erscheinungsdatum

16.02.2024

Verlag Elsevier Science & Technology
Seitenzahl

508

Maße (L/B/H)

22,9/19/2,8 cm

Gewicht

1038 g

Auflage

2nd edition

Sprache

Englisch

ISBN

978-0-443-21600-8

EU-Ansprechpartner

Elsevier B.V.
Radarweg 29
1043 NX Amsterdam
NL
productsafety@elsevier.com

Herstelleradresse

Elsevier Science & Technology
London Wall 125
EC2Y 5AS London
GB
tradeorders@elsevier.com

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  • Produktbild: Biocontamination Control for Pharmaceuticals and Healthcare
  • 1. Introduction
    2. Sources of biocontamination, other forms of contamination, and risk profiling
    3. GMP, regulations and standards
    4. Biocontamination control
    5. Application of Quality Risk Management and its application in biocontamination control
    6. Introduction to cleanrooms and environmental monitoring
    7. Viable monitoring methods
    8. Selection of culture media
    9. Airborne particle monitoring
    10. Rapid microbiological methods11. Designing an environmental monitoring programme
    11. Putting an environmental monitoring plan together: A risk-based case study
    12. Special Types of Environmental Monitoring
    13. Cleanrooms and microbiota
    14. Assessment of pharmaceutical water systems
    15. Data handling and trend analysi
    16. Bioburden and endotoxin assessment of pharmaceutical processing
    17. Risk assessment and investigation for environmental monitoring: Examples of microbial data deviations
    18. Assessing and removing contamination risks from the process
    19. The human factor: Training and controlling people in cleanrooms
    20. Biocontamination deviation management
    21. Synthesis: An anatomy of a contamination control strategy