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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 |
| 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 | ||
| ||
Industrial biotechnology [[electronic resource] ] : sustainable growth and economic success / / edited by Wim Soetaert and Erick J. Vandamme
| Industrial biotechnology [[electronic resource] ] : sustainable growth and economic success / / edited by Wim Soetaert and Erick J. Vandamme |
| Pubbl/distr/stampa | Weinheim, : Wiley-VCH, 2010 |
| Descrizione fisica | 1 online resource (523 p.) |
| Disciplina |
660.13
660.6 |
| Altri autori (Persone) |
SoetaertWim
VandammeErick J. <1943-> |
| Soggetto topico |
Biotechnology
Biotechnology - Social aspects |
| ISBN |
1-282-68661-5
9786612686610 3-527-63023-6 3-527-63024-4 |
| Classificazione |
CIT 900f
WF 9700 VN 8900 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
Industrial Biotechnology: Sustainable Growth and Economic Success; Contents; Preface; List of Contributors; The Scope and Impact of Industrial Biotechnology; 1: History of Industrial Biotechnology; 1.1 Early History; 1.2 The Penicillin Story; 1.3 The Coming of the Cephalosporins; 1.4 The Waksman Era; 1.5 Strain Improvement; 1.6 Semi-Synthetic Antibiotics to Combat Resistant Microbes; 1.7 The Primary Metabolites; 1.7.1 Amino Acids; 1.7.2 Nucleotides; 1.7.3 Vitamins; 1.7.4 Organic Acids; 1.7.5 Alcohols; 1.7.6 Polymers
1.7.7 Specialty Sugars, Sugar Alcohols,L-Sugars, Oligosugars, Novel Extracellular Polysaccharides, Biopigments, Cosmetics Including Fragrants, and Microbial Enzymes for Chiral Synthesis and Other Applications1.8 The Shift from Antibiotics to Pharmacological Agents; 1.8.1 Enzyme Inhibitors; 1.8.2 Immunosuppressants; 1.8.3 Antitumor Agents; 1.8.4 Ergot Alkaloids; 1.8.5 Agricultural Compounds; 1.9 The Biopharmaceutical Revolution; 1.9.1 Human Insulin (Novolin, Humulin); 1.9.2 Erythropoietin (Epogen, Procrit); 1.9.3 Interferons; 1.9.4 Human Growth Hormone (Somatotropin, Somatropin Humatrope, Nutropin, Protropin, Somatren, Serostim)1.9.5 Tissue Plasminogen Activator (Activase, Alteplase); 1.9.6 Interleukins; 1.9.7 Factor VIII; 1.9.8 Colony-Stimulating Factors; 1.9.9 Human DNase (Pulmozyme); 1.9.10 Glucocerebrosidas (Cerezyme); 1.9.11 Monoclonal Antibodies; 1.9.12 Additional Biopharmaceuticals; 1.10 Recombinant Hosts; 1.10.1 E. coli; 1.10.2 Yeasts; 1.10.3 Molds; 1.10.4 Insect Cells; 1.10.5 Mammalian Cells; 1.10.6 Transgenic Animals; 1.10.7 Transgenic Plants; 1.11 Enzymes; 1.12 Bioconversions; 1.13 Vaccines; 1.14 Systems Microbiology; References 2: Industrial Systems Biology2.1 Introduction; 2.2 Industrial Biotechnology; 2.3 Market Drivers for Industrial Biotechnology; 2.4 Industrial Systems Biology; 2.5 Metabolic Models; 2.5.1 Microbial Metabolism-A Historical Perspective; 2.5.2 Genome Sequencing and Functional Genomics; 2.6 Reconstructed Metabolic Network Models; 2.6.1 Introduction; 2.6.2 Genome-Scale Reconstructed Network Process; 2.7 Industrial Systems Biology Case Studies; 2.7.1 A Mature and Developed Industrial Biotechnology Product: Bioethanol 2.7.2 A Recently Launched and Rapidly Growing Industrial Biotechnology Product: 1,3-Propanediol2.7.3 An In-Development Industrial Biotechnology Product: Succinic Acid; 2.8 Conclusion and Future Perspectives; References; 3: Fermentation Technology; 3.1 Introduction; 3.2 Types of Fermentations; 3.3 Fermentation Process; 3.3.1 Inoculum Generation; 3.3.2 Growth and Product Formation; 3.4 Fermentation Medium Design; 3.5 Sterilization of Air and Fermentation Medium; 3.6 Environmental Factors; 3.7 Fermentation Kinetics; 3.7.1 Batch Fermentation; 3.7.2 Continuous Culture; 3.8 Fermentation Equipment 3.8.1 Submerged Fermentation |
| Record Nr. | UNINA-9910140551803321 |
| Weinheim, : Wiley-VCH, 2010 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Industrial biotechnology [[electronic resource] ] : sustainable growth and economic success / / edited by Wim Soetaert and Erick J. Vandamme
| Industrial biotechnology [[electronic resource] ] : sustainable growth and economic success / / edited by Wim Soetaert and Erick J. Vandamme |
| Pubbl/distr/stampa | Weinheim, : Wiley-VCH, 2010 |
| Descrizione fisica | 1 online resource (523 p.) |
| Disciplina |
660.13
660.6 |
| Altri autori (Persone) |
SoetaertWim
VandammeErick J. <1943-> |
| Soggetto topico |
Biotechnology
Biotechnology - Social aspects |
| ISBN |
1-282-68661-5
9786612686610 3-527-63023-6 3-527-63024-4 |
| Classificazione |
CIT 900f
WF 9700 VN 8900 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
Industrial Biotechnology: Sustainable Growth and Economic Success; Contents; Preface; List of Contributors; The Scope and Impact of Industrial Biotechnology; 1: History of Industrial Biotechnology; 1.1 Early History; 1.2 The Penicillin Story; 1.3 The Coming of the Cephalosporins; 1.4 The Waksman Era; 1.5 Strain Improvement; 1.6 Semi-Synthetic Antibiotics to Combat Resistant Microbes; 1.7 The Primary Metabolites; 1.7.1 Amino Acids; 1.7.2 Nucleotides; 1.7.3 Vitamins; 1.7.4 Organic Acids; 1.7.5 Alcohols; 1.7.6 Polymers
1.7.7 Specialty Sugars, Sugar Alcohols,L-Sugars, Oligosugars, Novel Extracellular Polysaccharides, Biopigments, Cosmetics Including Fragrants, and Microbial Enzymes for Chiral Synthesis and Other Applications1.8 The Shift from Antibiotics to Pharmacological Agents; 1.8.1 Enzyme Inhibitors; 1.8.2 Immunosuppressants; 1.8.3 Antitumor Agents; 1.8.4 Ergot Alkaloids; 1.8.5 Agricultural Compounds; 1.9 The Biopharmaceutical Revolution; 1.9.1 Human Insulin (Novolin, Humulin); 1.9.2 Erythropoietin (Epogen, Procrit); 1.9.3 Interferons; 1.9.4 Human Growth Hormone (Somatotropin, Somatropin Humatrope, Nutropin, Protropin, Somatren, Serostim)1.9.5 Tissue Plasminogen Activator (Activase, Alteplase); 1.9.6 Interleukins; 1.9.7 Factor VIII; 1.9.8 Colony-Stimulating Factors; 1.9.9 Human DNase (Pulmozyme); 1.9.10 Glucocerebrosidas (Cerezyme); 1.9.11 Monoclonal Antibodies; 1.9.12 Additional Biopharmaceuticals; 1.10 Recombinant Hosts; 1.10.1 E. coli; 1.10.2 Yeasts; 1.10.3 Molds; 1.10.4 Insect Cells; 1.10.5 Mammalian Cells; 1.10.6 Transgenic Animals; 1.10.7 Transgenic Plants; 1.11 Enzymes; 1.12 Bioconversions; 1.13 Vaccines; 1.14 Systems Microbiology; References 2: Industrial Systems Biology2.1 Introduction; 2.2 Industrial Biotechnology; 2.3 Market Drivers for Industrial Biotechnology; 2.4 Industrial Systems Biology; 2.5 Metabolic Models; 2.5.1 Microbial Metabolism-A Historical Perspective; 2.5.2 Genome Sequencing and Functional Genomics; 2.6 Reconstructed Metabolic Network Models; 2.6.1 Introduction; 2.6.2 Genome-Scale Reconstructed Network Process; 2.7 Industrial Systems Biology Case Studies; 2.7.1 A Mature and Developed Industrial Biotechnology Product: Bioethanol 2.7.2 A Recently Launched and Rapidly Growing Industrial Biotechnology Product: 1,3-Propanediol2.7.3 An In-Development Industrial Biotechnology Product: Succinic Acid; 2.8 Conclusion and Future Perspectives; References; 3: Fermentation Technology; 3.1 Introduction; 3.2 Types of Fermentations; 3.3 Fermentation Process; 3.3.1 Inoculum Generation; 3.3.2 Growth and Product Formation; 3.4 Fermentation Medium Design; 3.5 Sterilization of Air and Fermentation Medium; 3.6 Environmental Factors; 3.7 Fermentation Kinetics; 3.7.1 Batch Fermentation; 3.7.2 Continuous Culture; 3.8 Fermentation Equipment 3.8.1 Submerged Fermentation |
| Record Nr. | UNINA-9910830851103321 |
| Weinheim, : Wiley-VCH, 2010 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Industrial biotechnology : sustainable growth and economic success / / edited by Wim Soetaert and Erick J. Vandamme
| Industrial biotechnology : sustainable growth and economic success / / edited by Wim Soetaert and Erick J. Vandamme |
| Pubbl/distr/stampa | Weinheim, : Wiley-VCH, 2010 |
| Descrizione fisica | 1 online resource (523 p.) |
| Disciplina |
660.13
660.6 |
| Altri autori (Persone) |
SoetaertWim
VandammeErick J. <1943-> |
| Soggetto topico |
Biotechnology
Biotechnology - Social aspects |
| ISBN |
1-282-68661-5
9786612686610 3-527-63023-6 3-527-63024-4 |
| Classificazione |
CIT 900f
WF 9700 VN 8900 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
Industrial Biotechnology: Sustainable Growth and Economic Success; Contents; Preface; List of Contributors; The Scope and Impact of Industrial Biotechnology; 1: History of Industrial Biotechnology; 1.1 Early History; 1.2 The Penicillin Story; 1.3 The Coming of the Cephalosporins; 1.4 The Waksman Era; 1.5 Strain Improvement; 1.6 Semi-Synthetic Antibiotics to Combat Resistant Microbes; 1.7 The Primary Metabolites; 1.7.1 Amino Acids; 1.7.2 Nucleotides; 1.7.3 Vitamins; 1.7.4 Organic Acids; 1.7.5 Alcohols; 1.7.6 Polymers
1.7.7 Specialty Sugars, Sugar Alcohols,L-Sugars, Oligosugars, Novel Extracellular Polysaccharides, Biopigments, Cosmetics Including Fragrants, and Microbial Enzymes for Chiral Synthesis and Other Applications1.8 The Shift from Antibiotics to Pharmacological Agents; 1.8.1 Enzyme Inhibitors; 1.8.2 Immunosuppressants; 1.8.3 Antitumor Agents; 1.8.4 Ergot Alkaloids; 1.8.5 Agricultural Compounds; 1.9 The Biopharmaceutical Revolution; 1.9.1 Human Insulin (Novolin, Humulin); 1.9.2 Erythropoietin (Epogen, Procrit); 1.9.3 Interferons; 1.9.4 Human Growth Hormone (Somatotropin, Somatropin Humatrope, Nutropin, Protropin, Somatren, Serostim)1.9.5 Tissue Plasminogen Activator (Activase, Alteplase); 1.9.6 Interleukins; 1.9.7 Factor VIII; 1.9.8 Colony-Stimulating Factors; 1.9.9 Human DNase (Pulmozyme); 1.9.10 Glucocerebrosidas (Cerezyme); 1.9.11 Monoclonal Antibodies; 1.9.12 Additional Biopharmaceuticals; 1.10 Recombinant Hosts; 1.10.1 E. coli; 1.10.2 Yeasts; 1.10.3 Molds; 1.10.4 Insect Cells; 1.10.5 Mammalian Cells; 1.10.6 Transgenic Animals; 1.10.7 Transgenic Plants; 1.11 Enzymes; 1.12 Bioconversions; 1.13 Vaccines; 1.14 Systems Microbiology; References 2: Industrial Systems Biology2.1 Introduction; 2.2 Industrial Biotechnology; 2.3 Market Drivers for Industrial Biotechnology; 2.4 Industrial Systems Biology; 2.5 Metabolic Models; 2.5.1 Microbial Metabolism-A Historical Perspective; 2.5.2 Genome Sequencing and Functional Genomics; 2.6 Reconstructed Metabolic Network Models; 2.6.1 Introduction; 2.6.2 Genome-Scale Reconstructed Network Process; 2.7 Industrial Systems Biology Case Studies; 2.7.1 A Mature and Developed Industrial Biotechnology Product: Bioethanol 2.7.2 A Recently Launched and Rapidly Growing Industrial Biotechnology Product: 1,3-Propanediol2.7.3 An In-Development Industrial Biotechnology Product: Succinic Acid; 2.8 Conclusion and Future Perspectives; References; 3: Fermentation Technology; 3.1 Introduction; 3.2 Types of Fermentations; 3.3 Fermentation Process; 3.3.1 Inoculum Generation; 3.3.2 Growth and Product Formation; 3.4 Fermentation Medium Design; 3.5 Sterilization of Air and Fermentation Medium; 3.6 Environmental Factors; 3.7 Fermentation Kinetics; 3.7.1 Batch Fermentation; 3.7.2 Continuous Culture; 3.8 Fermentation Equipment 3.8.1 Submerged Fermentation |
| Record Nr. | UNINA-9910877793403321 |
| Weinheim, : Wiley-VCH, 2010 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||