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Cleaning validation manual : a comprehensive guide for the pharmaceutical and biotechnology industries / / Syed Imtiaz Haider, Erfan Syed Asif
| Cleaning validation manual : a comprehensive guide for the pharmaceutical and biotechnology industries / / Syed Imtiaz Haider, Erfan Syed Asif |
| Autore | Haider Syed Imtiaz |
| Pubbl/distr/stampa | Boca Raton : , : CRC Press, , 2010 |
| Descrizione fisica | 1 online resource (610 p.) |
| Disciplina | 615/.19 |
| Altri autori (Persone) | AsifErfan Syed |
| Soggetto topico |
Pharmaceutical industry - Equipment and supplies - Sterilization
Drug factories - Cleaning |
| Soggetto genere / forma | Electronic books. |
| ISBN |
0-429-15225-6
1-4398-2661-7 |
| Formato | Materiale a stampa  |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
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 (Tab-Cap-PPS); CLV-19: Worst-Case Products (Tablets, Capsules,and PPS) Matrix; CLV-20: Validation with Corresponding Cleaning Procedures; CLV-20.1: Cleaning Validation Protocol for Fluid Bed Dryer CLV-20.2: Cleaning Validation Protocol for MixerCLV-20.3: Cleaning Validation Protocol for Granulation Machines (Type A); CLV-20.4: Cleaning Validation Protocol for Powder Bins; CLV-20.5: Cleaning Validation Protocol for Tablet Press; CLV-20.6: Cleaning Validation Protocol for Sieve; CLV-20.7: Cleaning Validation Protocol for Powder-Filling Machine; CLV-20.8: Cleaning Validation Protocol for Encapsulation Machine; CLV-20.9: Cleaning Validation Protocol for Film-Coating Pan; CLV-20.10: Cleaning Validation Protocol for Sugar-Coating Pan CLV-21: Cleaning Validation Product Grouping Matrix (Syrup)CLV-22: Cleaning Validation Product/Equipment Train (Syrup); CLV-23: Worst-Case Products (Syrup; CLV-24: Cleaning Validation Product Grouping Matrix (Suspension); CLV-25: Product Grouping/Equipment Train Matrix (Suspension); CLV-26: Worst-Case Products (Suspension); CLV-27: Product Grouping Matrix (Drops); CLV-28: Product/Equipment Train (Drops); CLV-29: Worst-Case Products (Drops); CLV-30: Cleaning Validation Product Grouping Matrix (Cream/Ointment); CLV-31: Product/Equipment Train (Cream and Ointment) CLV-32: Worst-Case Products (Ointment and Cream)CLV-33: Product Grouping Matrix (Suppositories); CLV-34: Cleaning Validation Product/Equipment Train (Suppositories); CLV-35: Worst-Case Products (Suppositories); CLV-36: Cleaning Validation Protocols Products (Suppositories); CLV-36.1 Protocol for Manufacturing Vessel; CLV-36.2 Protocol for Bin-Washing Station; CLV-36.3 Cleaning Validation Protocol for Syrup-Holding Tank; CLV-36.4: Protocol for Filling Station and Filter Assembly; CLV-37: Cleaning Validation Product Grouping Matrix (Sterile) CLV-38 Cleaning Validation Product/Equipment Train Matrix (Sterile) |
| Record Nr. | UNINA-9910459137203321 |
Haider Syed Imtiaz
|
||
| Boca Raton : , : CRC Press, , 2010 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Cleaning validation manual : a comprehensive guide for the pharmaceutical and biotechnology industries / / Syed Imtiaz Haider, Erfan Syed Asif
| Cleaning validation manual : a comprehensive guide for the pharmaceutical and biotechnology industries / / Syed Imtiaz Haider, Erfan Syed Asif |
| Autore | Haider Syed Imtiaz |
| Pubbl/distr/stampa | Boca Raton : , : CRC Press, , 2010 |
| Descrizione fisica | 1 online resource (610 p.) |
| Disciplina | 615/.19 |
| Altri autori (Persone) | AsifErfan Syed |
| Soggetto topico |
Pharmaceutical industry - Equipment and supplies - Sterilization
Drug factories - Cleaning |
| ISBN |
0-429-15225-6
1-4398-2661-7 |
| Classificazione |
VN 7000
VN 8900 ZM 8360 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
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 (Tab-Cap-PPS); CLV-19: Worst-Case Products (Tablets, Capsules,and PPS) Matrix; CLV-20: Validation with Corresponding Cleaning Procedures; CLV-20.1: Cleaning Validation Protocol for Fluid Bed Dryer CLV-20.2: Cleaning Validation Protocol for MixerCLV-20.3: Cleaning Validation Protocol for Granulation Machines (Type A); CLV-20.4: Cleaning Validation Protocol for Powder Bins; CLV-20.5: Cleaning Validation Protocol for Tablet Press; CLV-20.6: Cleaning Validation Protocol for Sieve; CLV-20.7: Cleaning Validation Protocol for Powder-Filling Machine; CLV-20.8: Cleaning Validation Protocol for Encapsulation Machine; CLV-20.9: Cleaning Validation Protocol for Film-Coating Pan; CLV-20.10: Cleaning Validation Protocol for Sugar-Coating Pan CLV-21: Cleaning Validation Product Grouping Matrix (Syrup)CLV-22: Cleaning Validation Product/Equipment Train (Syrup); CLV-23: Worst-Case Products (Syrup; CLV-24: Cleaning Validation Product Grouping Matrix (Suspension); CLV-25: Product Grouping/Equipment Train Matrix (Suspension); CLV-26: Worst-Case Products (Suspension); CLV-27: Product Grouping Matrix (Drops); CLV-28: Product/Equipment Train (Drops); CLV-29: Worst-Case Products (Drops); CLV-30: Cleaning Validation Product Grouping Matrix (Cream/Ointment); CLV-31: Product/Equipment Train (Cream and Ointment) CLV-32: Worst-Case Products (Ointment and Cream)CLV-33: Product Grouping Matrix (Suppositories); CLV-34: Cleaning Validation Product/Equipment Train (Suppositories); CLV-35: Worst-Case Products (Suppositories); CLV-36: Cleaning Validation Protocols Products (Suppositories); CLV-36.1 Protocol for Manufacturing Vessel; CLV-36.2 Protocol for Bin-Washing Station; CLV-36.3 Cleaning Validation Protocol for Syrup-Holding Tank; CLV-36.4: Protocol for Filling Station and Filter Assembly; CLV-37: Cleaning Validation Product Grouping Matrix (Sterile) CLV-38 Cleaning Validation Product/Equipment Train Matrix (Sterile) |
| Record Nr. | UNINA-9910792699603321 |
|
Haider Syed Imtiaz
|
||
| Boca Raton : , : CRC Press, , 2010 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Cleaning validation manual : a comprehensive guide for the pharmaceutical and biotechnology industries / / Syed Imtiaz Haider, Erfan Syed Asif
| Cleaning validation manual : a comprehensive guide for the pharmaceutical and biotechnology industries / / Syed Imtiaz Haider, Erfan Syed Asif |
| Autore | Haider Syed Imtiaz |
| Edizione | [1st ed.] |
| Pubbl/distr/stampa | Boca Raton, : CRC Press/Taylor & Francis Group, c2010 |
| Descrizione fisica | 1 online resource (610 p.) |
| Disciplina | 615/.19 |
| Altri autori (Persone) | AsifErfan Syed |
| Soggetto topico |
Pharmaceutical industry - Equipment and supplies - Sterilization
Drug factories - Cleaning |
| ISBN |
0-429-15225-6
1-4398-2661-7 |
| Classificazione |
VN 7000
VN 8900 ZM 8360 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
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 (Tab-Cap-PPS); CLV-19: Worst-Case Products (Tablets, Capsules,and PPS) Matrix; CLV-20: Validation with Corresponding Cleaning Procedures; CLV-20.1: Cleaning Validation Protocol for Fluid Bed Dryer CLV-20.2: Cleaning Validation Protocol for MixerCLV-20.3: Cleaning Validation Protocol for Granulation Machines (Type A); CLV-20.4: Cleaning Validation Protocol for Powder Bins; CLV-20.5: Cleaning Validation Protocol for Tablet Press; CLV-20.6: Cleaning Validation Protocol for Sieve; CLV-20.7: Cleaning Validation Protocol for Powder-Filling Machine; CLV-20.8: Cleaning Validation Protocol for Encapsulation Machine; CLV-20.9: Cleaning Validation Protocol for Film-Coating Pan; CLV-20.10: Cleaning Validation Protocol for Sugar-Coating Pan CLV-21: Cleaning Validation Product Grouping Matrix (Syrup)CLV-22: Cleaning Validation Product/Equipment Train (Syrup); CLV-23: Worst-Case Products (Syrup; CLV-24: Cleaning Validation Product Grouping Matrix (Suspension); CLV-25: Product Grouping/Equipment Train Matrix (Suspension); CLV-26: Worst-Case Products (Suspension); CLV-27: Product Grouping Matrix (Drops); CLV-28: Product/Equipment Train (Drops); CLV-29: Worst-Case Products (Drops); CLV-30: Cleaning Validation Product Grouping Matrix (Cream/Ointment); CLV-31: Product/Equipment Train (Cream and Ointment) CLV-32: Worst-Case Products (Ointment and Cream)CLV-33: Product Grouping Matrix (Suppositories); CLV-34: Cleaning Validation Product/Equipment Train (Suppositories); CLV-35: Worst-Case Products (Suppositories); CLV-36: Cleaning Validation Protocols Products (Suppositories); CLV-36.1 Protocol for Manufacturing Vessel; CLV-36.2 Protocol for Bin-Washing Station; CLV-36.3 Cleaning Validation Protocol for Syrup-Holding Tank; CLV-36.4: Protocol for Filling Station and Filter Assembly; CLV-37: Cleaning Validation Product Grouping Matrix (Sterile) CLV-38 Cleaning Validation Product/Equipment Train Matrix (Sterile) |
| Record Nr. | UNINA-9910818795703321 |
|
Haider Syed Imtiaz
|
||
| Boca Raton, : CRC Press/Taylor & Francis Group, c2010 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||