Biocontamination Control for Pharmaceuticals and Healthcare. (2018)

• Record Type: Book
• Further Information: Note: Tim Sandle.
• Authors: Sandle, Tim
• 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 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 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 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
• Publisher Details: Place of publication not identified : Elsevier Ltd Academic Press
• Publication Date: 2018
• Extent: 1 online resource
• Subjects: 615.19; Drugs -- Sterilization; Sterilization; MEDICAL / Pharmacology; Electronic books
• Languages: English
• ISBNs: 9780128149126; 0128149124
• Related ISBNs: 9780128149119
• Notes: Note: Includes bibliographical references.; Note: Online resource; title from PDF file page (EBSCO, viewed December 5, 2018).
• Access Rights: Legal Deposit; Only available on premises controlled by the deposit library and to one user at any one time; The Legal Deposit Libraries (Non-Print Works) Regulations (UK).
• Access Usage: Restricted: Printing from this resource is governed by The Legal Deposit Libraries (Non-Print Works) Regulations (UK) and UK copyright law currently in force.