LEADER 05447nam 2200649Ia 450 001 9910841210703321 005 20210604114624.0 010 $a1-118-44905-3 010 $a1-283-64526-2 010 $a1-118-44906-1 010 $a1-118-44908-8 035 $a(CKB)2670000000260803 035 $a(EBL)947722 035 $a(OCoLC)812914928 035 $a(SSID)ssj0000719047 035 $a(PQKBManifestationID)11448793 035 $a(PQKBTitleCode)TC0000719047 035 $a(PQKBWorkID)10762446 035 $a(PQKB)10733087 035 $a(MiAaPQ)EBC947722 035 $a(PPN)179026119 035 $a(EXLCZ)992670000000260803 100 $a20120629d2012 uy 0 101 0 $aeng 135 $aur|n|---||||| 181 $ctxt 182 $cc 183 $acr 200 10$aSources of contamination in medicinal products and medical devices$b[electronic resource] /$fDenise Bohrer 210 $aHoboken, N.J. $cWiley$d2012 215 $a1 online resource (593 p.) 300 $aDescription based upon print version of record. 311 $a0-470-48750-X 320 $aIncludes bibliographical references and index. 327 $aTitle 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 327 $a5.1.1 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 327 $aConcluding 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 327 $a11.2 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 327 $a12.1.4 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 327 $aAppendix Polymeric Materials: Components, Additives, Extractables, and Degradation Products 330 $aThe first one-volume guide to sources of contamination in pharmaceuticals and medical devices Most books dealing with contaminants in medicinal products often focus on analytical methods for detecting nonspecific impurities. Key to the work of the pharmaceutical chemist, this unique reference helps identify the sources of contamination in medicinal and pharmaceutical products and medical devices. Divided into three parts, Sources of Contamination in Medicinal Products and Medical Devices covers chemical, microbiological, and physical (particulate matter) contamination, i 606 $aMicrobial contamination 606 $aPharmaceutical industry$xQuality control 606 $aPharmaceutical technology$xStandards 615 0$aMicrobial contamination. 615 0$aPharmaceutical industry$xQuality control. 615 0$aPharmaceutical technology$xStandards. 676 $a338.4/76151 676 $a338.476151 700 $aBohrer$b Denise$01730332 801 0$bMiAaPQ 801 1$bMiAaPQ 801 2$bMiAaPQ 906 $aBOOK 912 $a9910841210703321 996 $aSources of contamination in medicinal products and medical devices$94141377 997 $aUNINA