| Description |
1 online resource |
| Contents |
Front Cover; Biocontamination Control for Pharmaceuticals and Healthcare; Copyright; Contents; Chapter 1: Introduction to Biocontamination and Biocontamination Control; Introduction; Conclusion; References; Chapter 2: Sources of Microbial Contamination and Risk Profiling; Introduction; Types of Microorganisms; Assessing Product Risks; Sources of Microbial Contamination; Air; Water; Materials and Surfaces; People; Weaknesses With Environmental Controls; Facility Repairs and Maintenance; Remediation Actives; Effective Cleaning and Disinfection; Environmental Monitoring; Summary; References |
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Chapter 3: GMP, Regulations and StandardsIntroduction; Cleanrooms and Classification; European Regulations; North American; Synergy of US and European Regulations; International; ISO 14644; Particle Sizes to be Measured; Number of Locations to be Measured Within the Cleanroom; Location of Particle Counters Within the Cleanroom; Volume of Air to be Sampled; Assessing Results; ISO 14698 Biocontamination Control and Microbiological Monitoring Methods; cGMP; The Issue of Limits: Competing Standards; Common GMP Deficiencies; Documentation and Record Keeping; Summary; References |
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Chapter 4: Biocontamination Control StrategyIntroduction; Regulatory Expectations; Biocontamination Control Strategy; Understanding the Design of Both the Plant and Process; Detail of Equipment and Facilities; Training and Control of Personnel; Control of Utilities; Raw Materials Control; Product Development; In-Process Controls; Product Containers and Closures; Vendor Approval; Outsourced Services; Process Risk Assessment; Process Validation; Preventative Maintenance; Cleaning and Disinfection; Monitoring Systems; Prevention; Data Recording and Handling; Continuous Improvement; Summary |
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Qualification Criteria for SwabsContact Plates; Selection of Contact Plates and Sampling Methods; Personnel Monitoring; Summary; References; Chapter 7: Selection and Application of Culture Media; Introduction; Defining Culture Media; Supply of Culture Media; Types of Culture Media Used for Biocontamination Control; Tryptone Soy Agar; Nutrient Agar; Sabouraud Dextrose Agar; Blood Agar; Quality Control Testing; Incubation Strategies for Environmental Monitoring; Temperatures of Incubation and Microbial Recovery; General-Purpose Culture Media; Incubation Strategies |
| Summary |
Biocontamination Control for Pharmaceuticals and Healthcare outlines a biocontamination strategy that tracks bio-burden control and reduction at each transition in classified areas of a facility. This key part of controlling risk escalation can lead to the contamination of medicinal products, hence necessary tracking precautions are essential. Regulatory authorities have challenged pharmaceutical companies, healthcare providers, and those in manufacturing practice to adopt a holistic approach to contamination control. New technologies are needed to introduce barriers between personnel and the environment, and to provide a rapid and more accurate assessment of risk. This book offers guidance on building a complete biocontamination strategy |
| Bibliography |
Includes bibliographical references |
| Notes |
Online resource; title from PDF file page (EBSCO, viewed December 5, 2018) |
| Subject |
Drugs -- Sterilization.
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Sterilization.
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MEDICAL -- Pharmacology.
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Drugs -- Sterilization
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Sterilization
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| Genre/Form |
Electronic books
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| Form |
Electronic book
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| ISBN |
9780128149126 |
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0128149124 |
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