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Sources of contamination in medicinal products and medical devices [[electronic resource] /] / Denise Bohrer
Sources of contamination in medicinal products and medical devices [[electronic resource] /] / Denise Bohrer
Autore Bohrer Denise
Pubbl/distr/stampa Hoboken, N.J., : Wiley, 2012
Descrizione fisica 1 online resource (593 p.)
Disciplina 338.4/76151
338.476151
Soggetto topico Microbial contamination
Pharmaceutical industry - Quality control
Pharmaceutical technology - Standards
ISBN 1-118-44905-3
1-283-64526-2
1-118-44906-1
1-118-44908-8
Formato Materiale a stampa
Livello bibliografico Monografia
Lingua di pubblicazione eng
Nota di contenuto Title page; Copyright page; Contents; Preface; Acknowledgments; 1: Introduction; Reference; 2: Directives for Contamination Control; PART I: Chemical Contamination; 3: Raw Materials; 3.1 Water; 3.2 Inorganic Impurities; 3.3 Organic Impurities; 3.3.1 By-products; 3.3.2 Genotoxic Impurities (GTIs); 3.3.3 Degradation Products; 3.4 Additives; 3.5 Residual Solvents; Concluding Remarks; References; 4: Medicinal Gases and Volatile Anesthetics; 4.1 Medicinal Gases; 4.2 Volatile Anesthetics; Concluding Remarks; References; 5: Diagnostic Imaging Agents; 5.1 Radiopharmaceuticals
5.1.1 Technetium-Based Products5.1.2 Iodine-Based Products; 5.1.3 Fluorine-Based Products; 5.2 Contrast Agents; 5.2.1 Gadolinium-Based Products; 5.2.2 Iodine-Based Products; 5.2.3 Barium Sulfate; Concluding Remarks; References; 6: Containers; 6.1 Glass Containers; 6.2 Plastic Containers; 6.2.1 Polymer Formation; 6.2.2 PVC Containers; 6.2.3 Other Plastic Containers; 6.3 Metal Containers; Concluding Remarks; References; 7: Closures; Concluding Remarks; References; 8: Delivery Systems and Filters; 8.1 Delivery Systems Made of PVC; 8.2 Delivery Systems Made of Other Plastic Materials; 8.3 Filters
Concluding RemarksReferences; 9: Medical Devices; 9.1 General Use Devices; 9.1.1 Medical Gloves; 9.1.2 Syringes; 9.2 Extracorporeal Circuits; 9.3 Devices for Administration of Aerosolized Drugs; 9.4 Reprocessed Medical Devices; 9.5 Tissue Substitutes; 9.5.1 Skin Substitutes and Surgical Dressings; 9.5.2 Hard Tissue Substitutes; 9.5.3 Soft Tissue Substitutes; Concluding Remarks; References; PART II: Physical Contamination; 10: Particulate Matter; Concluding Remarks; References; PART III: Microbiological Contamination; 11: Microbiological and Endotoxin Contamination; 11.1 Water
11.2 Raw Materials11.3 Sterile Products; 11.3.1 Single- and Multiple-Dose Products; 11.3.2 Parenteral Nutrition (PN); 11.3.3 Propofol; 11.3.4 Ophthalmic Products; 11.4 Medicinal Gases; 11.5 Medical Devices; 11.5.1 Syringes; 11.5.2 Endoscopes; 11.5.3 Other Devices; 11.6 Biofilms; 11.7 Dialysis Circuits; 11.8 Nosocomial Infections; Concluding Remarks; References; PART IV: Miscellaneous; 12: Contamination from Sterilization Procedures; 12.1 Residuals from Radiation Sterilization; 12.1.1 Radiolysis of Water; 12.1.2 Effect of Ionizing Radiation on Drug Products; 12.1.3 Polymers in Drug Delivery
12.1.4 Radiolysis of Selected Nondrug Components12.1.5 Effect of Ionizing Radiation on Materials Used in Packaging and in Medical Devices; 12.2 Heat Sterilization; 12.3 Residuals from Chemical Disinfection and Sterilization Agents; 12.3.1 Ethylene Oxide (EtO); 12.3.2 Peracetic Acid and Hydrogen Peroxide; 12.3.3 Formaldehyde; Concluding Remarks; References; 13: Biotechnological Products; 13.1 DNA and HCP Residuals; 13.2 Viruses and Mycoplasma; 13.3 Endotoxin; 13.4 Protein Degradation; 13.5 Protein Aggregation; Concluding Remarks; References
Appendix Polymeric Materials: Components, Additives, Extractables, and Degradation Products
Record Nr. UNINA-9910141378403321
Bohrer Denise  
Hoboken, N.J., : Wiley, 2012
Materiale a stampa
Lo trovi qui: Univ. Federico II
Opac: Controlla la disponibilità qui
Sources of contamination in medicinal products and medical devices [[electronic resource] /] / Denise Bohrer
Sources of contamination in medicinal products and medical devices [[electronic resource] /] / Denise Bohrer
Autore Bohrer Denise
Pubbl/distr/stampa Hoboken, N.J., : Wiley, 2012
Descrizione fisica 1 online resource (593 p.)
Disciplina 338.4/76151
338.476151
Soggetto topico Microbial contamination
Pharmaceutical industry - Quality control
Pharmaceutical technology - Standards
ISBN 1-118-44905-3
1-283-64526-2
1-118-44906-1
1-118-44908-8
Formato Materiale a stampa
Livello bibliografico Monografia
Lingua di pubblicazione eng
Nota di contenuto Title page; Copyright page; Contents; Preface; Acknowledgments; 1: Introduction; Reference; 2: Directives for Contamination Control; PART I: Chemical Contamination; 3: Raw Materials; 3.1 Water; 3.2 Inorganic Impurities; 3.3 Organic Impurities; 3.3.1 By-products; 3.3.2 Genotoxic Impurities (GTIs); 3.3.3 Degradation Products; 3.4 Additives; 3.5 Residual Solvents; Concluding Remarks; References; 4: Medicinal Gases and Volatile Anesthetics; 4.1 Medicinal Gases; 4.2 Volatile Anesthetics; Concluding Remarks; References; 5: Diagnostic Imaging Agents; 5.1 Radiopharmaceuticals
5.1.1 Technetium-Based Products5.1.2 Iodine-Based Products; 5.1.3 Fluorine-Based Products; 5.2 Contrast Agents; 5.2.1 Gadolinium-Based Products; 5.2.2 Iodine-Based Products; 5.2.3 Barium Sulfate; Concluding Remarks; References; 6: Containers; 6.1 Glass Containers; 6.2 Plastic Containers; 6.2.1 Polymer Formation; 6.2.2 PVC Containers; 6.2.3 Other Plastic Containers; 6.3 Metal Containers; Concluding Remarks; References; 7: Closures; Concluding Remarks; References; 8: Delivery Systems and Filters; 8.1 Delivery Systems Made of PVC; 8.2 Delivery Systems Made of Other Plastic Materials; 8.3 Filters
Concluding RemarksReferences; 9: Medical Devices; 9.1 General Use Devices; 9.1.1 Medical Gloves; 9.1.2 Syringes; 9.2 Extracorporeal Circuits; 9.3 Devices for Administration of Aerosolized Drugs; 9.4 Reprocessed Medical Devices; 9.5 Tissue Substitutes; 9.5.1 Skin Substitutes and Surgical Dressings; 9.5.2 Hard Tissue Substitutes; 9.5.3 Soft Tissue Substitutes; Concluding Remarks; References; PART II: Physical Contamination; 10: Particulate Matter; Concluding Remarks; References; PART III: Microbiological Contamination; 11: Microbiological and Endotoxin Contamination; 11.1 Water
11.2 Raw Materials11.3 Sterile Products; 11.3.1 Single- and Multiple-Dose Products; 11.3.2 Parenteral Nutrition (PN); 11.3.3 Propofol; 11.3.4 Ophthalmic Products; 11.4 Medicinal Gases; 11.5 Medical Devices; 11.5.1 Syringes; 11.5.2 Endoscopes; 11.5.3 Other Devices; 11.6 Biofilms; 11.7 Dialysis Circuits; 11.8 Nosocomial Infections; Concluding Remarks; References; PART IV: Miscellaneous; 12: Contamination from Sterilization Procedures; 12.1 Residuals from Radiation Sterilization; 12.1.1 Radiolysis of Water; 12.1.2 Effect of Ionizing Radiation on Drug Products; 12.1.3 Polymers in Drug Delivery
12.1.4 Radiolysis of Selected Nondrug Components12.1.5 Effect of Ionizing Radiation on Materials Used in Packaging and in Medical Devices; 12.2 Heat Sterilization; 12.3 Residuals from Chemical Disinfection and Sterilization Agents; 12.3.1 Ethylene Oxide (EtO); 12.3.2 Peracetic Acid and Hydrogen Peroxide; 12.3.3 Formaldehyde; Concluding Remarks; References; 13: Biotechnological Products; 13.1 DNA and HCP Residuals; 13.2 Viruses and Mycoplasma; 13.3 Endotoxin; 13.4 Protein Degradation; 13.5 Protein Aggregation; Concluding Remarks; References
Appendix Polymeric Materials: Components, Additives, Extractables, and Degradation Products
Record Nr. UNINA-9910830989003321
Bohrer Denise  
Hoboken, N.J., : Wiley, 2012
Materiale a stampa
Lo trovi qui: Univ. Federico II
Opac: Controlla la disponibilità qui