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Cleaning Validation Manual : a Comprehensive Guide for the Pharmaceutical and Biotechnology Industries.
Provides technical solutions to assist in fulfilling the training needs of finished pharmaceutical manufacturers. This work is suitable for those involved in the development, manufacturing, auditing, and validation of bio-pharmaceuticals on a pilot scale, leading to scaled-up production.
| Clasificación: | Libro Electrónico |
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| Autor principal: | |
| Formato: | Electrónico eBook |
| Idioma: | Inglés |
| Publicado: |
Hoboken :
CRC Press,
2010.
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| Temas: | |
| Acceso en línea: | Texto completo |
Tabla de Contenidos:
- Front cover; Contents; List of Figures; List of Tables; About the Book; Preface; Acknowledgments; Authors; Introduction; Disclaimer; CLV-1: How to Establish a Cleaning Validation Program; Body; CLV-2: Introduction; CLV-3: Scope and Approach; CLV-4: Cleaning Validation Team Membersand Responsibilities; CLV-5: Cleaning Validation Philosophy, Strategies, and Methodology; CLV-6: Planning Phase; CLV-7: Execution Phase; CLV-8: Analytical Testing and Reporting Phase; CLV-9: Equipment Description; CLV-10: Facility Description; CLV-11: Utilities Description: DIW, WFI, Steam, and Compressed Air.
- CLV-12: Utilities Monitoring and Microbiological ControlCLV-13: Equipment Cleaning Materials/DetergentDescription; CLV-14: Microbiological Cleaning of Equipment Surface; CLV-15: Solubility of Active Materials in Water; CLV-16: Toxicity of Active Materials; CLV-17: Cleaning Validation Products Grouping Matrix (Tablets, Capsules, and PPS); CLV-18: Product/Equipment Train Matrix (TabCapPPS); CLV-19: Worst-Case Products (Tablets, Cap.