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Biocontamination Control for Pharmaceuticals and Healthcare /
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...
| Clasificación: | Libro Electrónico |
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| Autor principal: | |
| Formato: | Electrónico eBook |
| Idioma: | Inglés |
| Publicado: |
[Place of publication not identified] :
Elsevier Ltd. : Academic Press,
2018.
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| Temas: | |
| Acceso en línea: | Texto completo |
Tabla de Contenidos:
- 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