| Description |
1 online resource (610 pages) |
| Contents |
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 |
| Summary |
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 |
| Notes |
Print version record |
| Subject |
Drug factories -- Equipment and supplies -- Cleaning -- Handbooks, manuals, etc
|
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Biotechnology industries -- Equipment and supplies -- Cleaning -- Handbooks, manuals, etc
|
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Medical instruments and apparatus -- Sterilization -- Handbooks, manuals, etc
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MEDICAL -- Pharmacology.
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Medical instruments and apparatus -- Sterilization
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| Genre/Form |
Handbooks and manuals
|
| Form |
Electronic book
|
| ISBN |
9781439826614 |
|
1439826617 |
|
