{"product_id":"sources-of-contamination-in-medicinal-products-and-medical-devices-hardback-9780470487501","title":"Sources of Contamination in Medicinal Products and Medical Devices (Hardback) 9780470487501","description":"\u003cfont face=\"Georgia\"\u003e\r\n\u003cp\u003e\u003cfont size=\"6\"\u003eSources of Contamination in Medicinal Products and Medical Devices\u003c\/font\u003e\u003cbr\u003e\r\n\r\n\r\n\r\n\r\n\r\n\u003c\/p\u003e\n\u003cp\u003e\u003cfont size=\"4\"\u003eDenise Bohrer (Author)\u003c\/font\u003e\u003c\/p\u003e\r\n\r\n\u003cp\u003e\u003cfont size=\"3\"\u003e9780470487501, Wiley\u003c\/font\u003e\u003c\/p\u003e\r\n\r\n\u003cp\u003e\u003cfont size=\"3\"\u003eHardback, published 11 December 2012\u003c\/font\u003e\u003c\/p\u003e\r\n\r\n\u003cp\u003e\u003cfont size=\"3\"\u003e592 pages\u003cbr\u003e23.1 x 15.5 x 3.6 cm, 0.953 kg\u003c\/font\u003e\u003c\/p\u003e\r\n\r\n\r\n\r\n\r\n\r\n\u003cp align=\"justify\"\u003e\u003cstrong\u003e\u003cfont size=\"3\"\u003e\u003cp\u003e\u003cb\u003eThe first one-volume guide to sources of contamination in pharmaceuticals and medical devices\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003eMost 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,\u003ci\u003e Sources of Contamination in Medicinal Products and Medical Devices\u003c\/i\u003e covers chemical, microbiological, and physical (particulate matter) contamination, including those originating from sterilization procedures.\u003c\/p\u003e \u003cp\u003eAs compelling as a medical documentary, the book sheds light on how impurities and contaminants can enter the human body transported via a specific product or treatment. Focusing on only those medicinal products and medical devices that may lead to exposure to contaminants harmful to human health, the book offers a comprehensive, systematic look at the entire universe of medical contamination:\u003c\/p\u003e \u003cul\u003e \u003cli\u003eChemical contaminants including residual solvents, catalyst residuals, and genotoxic impurities in active pharmaceutical ingredients (APIs)\u003c\/li\u003e \u003cli\u003eDiagnostic imaging agents (i.e., radiopharmaceuticals and contrast agents)\u003c\/li\u003e \u003cli\u003eMicrobiological and endotoxin contamination involving single and multiple dose products, medical devices, and biofilms\u003c\/li\u003e \u003cli\u003eContamination from sterilization procedures, residuals from radiation sterilization, ionizing radiation on packaging materials and medical devices\u003c\/li\u003e \u003cli\u003eMedicinal gases and volatile anesthetics\u003c\/li\u003e \u003cli\u003eBiopharmaceuticals including recombinant DNA technology products\u003c\/li\u003e \u003cli\u003eExtractables and leachables from containers made of glass, plastics, and metal\u003c\/li\u003e \u003c\/ul\u003e \u003cp\u003eEach section of the book contains information on what contaminants could be expected in a particular product, and how they were generated and reached that product. With up-to-date regulatory guidelines for determining contamination, as well as methods for assessing, quantifying, avoiding and removing contaminants, \u003ci\u003eSources of Contamination in Medicinal Products and Medical Devices\u003c\/i\u003e is essential to fully understanding the specific threats that undermine the safety of medicines and medical devices.\u003c\/p\u003e\u003c\/font\u003e\u003c\/strong\u003e\u003c\/p\u003e\r\n\r\n\u003cp\u003e\u003cfont size=\"3\"\u003e\u003cp\u003ePreface xv\u003c\/p\u003e \u003cp\u003eAcknowledgments xix\u003c\/p\u003e \u003cp\u003e\u003cb\u003e1 Introduction 1\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003eReference 6\u003c\/p\u003e \u003cp\u003e\u003cb\u003e2 Directives for Contamination Control 7\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e\u003cb\u003ePart I Chemical Contamination 17\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e\u003cb\u003e3 Raw Materials 19\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e3.1 Water 19\u003c\/p\u003e \u003cp\u003e3.2 Inorganic Impurities 27\u003c\/p\u003e \u003cp\u003e3.3 Organic Impurities 32\u003c\/p\u003e \u003cp\u003e3.3.1 By-products 32\u003c\/p\u003e \u003cp\u003e3.3.2 Genotoxic Impurities (GTIs) 35\u003c\/p\u003e \u003cp\u003e3.3.3 Degradation Products 39\u003c\/p\u003e \u003cp\u003e3.4 Additives 52\u003c\/p\u003e \u003cp\u003e3.5 Residual Solvents 58\u003c\/p\u003e \u003cp\u003eConcluding Remarks 63\u003c\/p\u003e \u003cp\u003eReferences 65\u003c\/p\u003e \u003cp\u003e\u003cb\u003e4 Medicinal Gases and Volatile Anesthetics 70\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e4.1 Medicinal Gases 70\u003c\/p\u003e \u003cp\u003e4.2 Volatile Anesthetics 80\u003c\/p\u003e \u003cp\u003eConcluding Remarks 93\u003c\/p\u003e \u003cp\u003eReferences 94\u003c\/p\u003e \u003cp\u003e\u003cb\u003e5 Diagnostic Imaging Agents 96\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e5.1 Radiopharmaceuticals 98\u003c\/p\u003e \u003cp\u003e5.1.1 Technetium-Based Products 100\u003c\/p\u003e \u003cp\u003e5.1.1.1 Production of Mo-99 100\u003c\/p\u003e \u003cp\u003e5.1.1.2 Generation of Tc-99m 103\u003c\/p\u003e \u003cp\u003e5.1.1.3 Labeling Procedures 107\u003c\/p\u003e \u003cp\u003e5.1.2 Iodine-Based Products 113\u003c\/p\u003e \u003cp\u003e5.1.3 Fluorine-Based Products 125\u003c\/p\u003e \u003cp\u003e5.1.3.1 [\u003csup\u003e18\u003c\/sup\u003eF]FDG Production and Labeling 127\u003c\/p\u003e \u003cp\u003e5.1.3.2 Species Formed during [\u003csup\u003e18\u003c\/sup\u003eO]H\u003csub\u003e\u003ci\u003e2\u003c\/i\u003e\u003c\/sub\u003eO Irradiation 128\u003c\/p\u003e \u003cp\u003e5.1.3.3 Residual Solvents and Components Used in the Labeling 137\u003c\/p\u003e \u003cp\u003e5.1.3.4 Radiolysis Products Generated by Elevated Activity of the Labeled Compound 140\u003c\/p\u003e \u003cp\u003e5.2 Contrast Agents 143\u003c\/p\u003e \u003cp\u003e5.2.1 Gadolinium-Based Products 143\u003c\/p\u003e \u003cp\u003e5.2.2 Iodine-Based Products 158\u003c\/p\u003e \u003cp\u003e5.2.3 Barium Sulfate 172\u003c\/p\u003e \u003cp\u003eConcluding Remarks 176\u003c\/p\u003e \u003cp\u003eReferences 177\u003c\/p\u003e \u003cp\u003e\u003cb\u003e6 Containers 185\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e6.1 Glass Containers 185\u003c\/p\u003e \u003cp\u003e6.2 Plastic Containers 199\u003c\/p\u003e \u003cp\u003e6.2.1 Polymer Formation 199\u003c\/p\u003e \u003cp\u003e6.2.2 PVC Containers 203\u003c\/p\u003e \u003cp\u003e6.2.3 Other Plastic Containers 215\u003c\/p\u003e \u003cp\u003e6.3 Metal Containers 220\u003c\/p\u003e \u003cp\u003eConcluding Remarks 223\u003c\/p\u003e \u003cp\u003eReferences 223\u003c\/p\u003e \u003cp\u003e\u003cb\u003e7 Closures 228\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003eConcluding Remarks 256\u003c\/p\u003e \u003cp\u003eReferences 256\u003c\/p\u003e \u003cp\u003e\u003cb\u003e8 Delivery Systems and Filters 259\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e8.1 Delivery Systems Made of PVC 260\u003c\/p\u003e \u003cp\u003e8.2 Delivery Systems Made of Other Plastic Materials 275\u003c\/p\u003e \u003cp\u003e8.3 Filters 282\u003c\/p\u003e \u003cp\u003eConcluding Remarks 287\u003c\/p\u003e \u003cp\u003eReferences 287\u003c\/p\u003e \u003cp\u003e\u003cb\u003e9 Medical Devices 290\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e9.1 General Use Devices 293\u003c\/p\u003e \u003cp\u003e9.1.1 Medical Gloves 294\u003c\/p\u003e \u003cp\u003e9.1.2 Syringes 294\u003c\/p\u003e \u003cp\u003e9.2 Extracorporeal Circuits 300\u003c\/p\u003e \u003cp\u003e9.3 Devices for Administration of Aerosolized Drugs 307\u003c\/p\u003e \u003cp\u003e9.4 Reprocessed Medical Devices 308\u003c\/p\u003e \u003cp\u003e9.5 Tissue Substitutes 309\u003c\/p\u003e \u003cp\u003e9.5.1 Skin Substitutes and Surgical Dressings 310\u003c\/p\u003e \u003cp\u003e9.5.2 Hard Tissue Substitutes 310\u003c\/p\u003e \u003cp\u003e9.5.3 Soft Tissue Substitutes 311\u003c\/p\u003e \u003cp\u003eConcluding Remarks 313\u003c\/p\u003e \u003cp\u003eReferences 313\u003c\/p\u003e \u003cp\u003e\u003cb\u003ePart II Physical Contamination 317\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e\u003cb\u003e10 Particulate Matter 319\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003eConcluding Remarks 345\u003c\/p\u003e \u003cp\u003eReferences 345\u003c\/p\u003e \u003cp\u003e\u003cb\u003ePart III Microbiological Contamination 349\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e\u003cb\u003e11 Microbiological and Endotoxin Contamination 351\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e11.1 Water 355\u003c\/p\u003e \u003cp\u003e11.2 Raw Materials 361\u003c\/p\u003e \u003cp\u003e11.3 Sterile Products 367\u003c\/p\u003e \u003cp\u003e11.3.1 Single- and Multiple-Dose Products 368\u003c\/p\u003e \u003cp\u003e11.3.2 Parenteral Nutrition (PN) 371\u003c\/p\u003e \u003cp\u003e11.3.3 Propofol 378\u003c\/p\u003e \u003cp\u003e11.3.4 Ophthalmic Products 384\u003c\/p\u003e \u003cp\u003e11.4 Medicinal Gases 393\u003c\/p\u003e \u003cp\u003e11.5 Medical Devices 394\u003c\/p\u003e \u003cp\u003e11.5.1 Syringes 395\u003c\/p\u003e \u003cp\u003e11.5.2 Endoscopes 398\u003c\/p\u003e \u003cp\u003e11.5.3 Other Devices 401\u003c\/p\u003e \u003cp\u003e11.6 Biofilms 406\u003c\/p\u003e \u003cp\u003e11.7 Dialysis Circuits 407\u003c\/p\u003e \u003cp\u003e11.8 Nosocomial Infections 413\u003c\/p\u003e \u003cp\u003eConcluding Remarks 420\u003c\/p\u003e \u003cp\u003eReferences 422\u003c\/p\u003e \u003cp\u003e\u003cb\u003ePart IV Miscellaneous 433\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e\u003cb\u003e12 Contamination from Sterilization Procedures 435\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e12.1 Residuals from Radiation Sterilization 437\u003c\/p\u003e \u003cp\u003e12.1.1 Radiolysis of Water 438\u003c\/p\u003e \u003cp\u003e12.1.2 Effect of Ionizing Radiation on Drug Products 439\u003c\/p\u003e \u003cp\u003e12.1.3 Polymers in Drug Delivery 440\u003c\/p\u003e \u003cp\u003e12.1.3.1 Polylactide (PLA) and Poly(lactide-co-glycolide) (PLGA) 443\u003c\/p\u003e \u003cp\u003e12.1.3.2 Collagen 448\u003c\/p\u003e \u003cp\u003e12.1.3.3 Cellulose and Other Polysaccharides 448\u003c\/p\u003e \u003cp\u003e12.1.3.4 Alginate 450\u003c\/p\u003e \u003cp\u003e12.1.4 Radiolysis of Selected Nondrug Components 450\u003c\/p\u003e \u003cp\u003e12.1.4.1 Residual Solvents 450\u003c\/p\u003e \u003cp\u003e12.1.4.2 Monosaccharides 451\u003c\/p\u003e \u003cp\u003e12.1.4.3 Starch 451\u003c\/p\u003e \u003cp\u003e12.1.5 Effect of Ionizing Radiation on Materials Used in Packaging and in Medical Devices 454\u003c\/p\u003e \u003cp\u003e12.1.5.1 Ultra-High-Molecular-Weight Polyethylene (UHMWPE) 456\u003c\/p\u003e \u003cp\u003e12.1.5.2 Polyurethane (PU) 458\u003c\/p\u003e \u003cp\u003e12.1.5.3 Silicone 464\u003c\/p\u003e \u003cp\u003e12.1.5.4 Polyamide (PA) 464\u003c\/p\u003e \u003cp\u003e12.1.5.5 Poly(methyl methacrylate) (PMMA) 466\u003c\/p\u003e \u003cp\u003e12.1.5.6 Polytetrafluoroethylene (PTFE) 468\u003c\/p\u003e \u003cp\u003e12.1.5.7 Polyvinyl Chloride (PVC) 468\u003c\/p\u003e \u003cp\u003e12.1.5.8 Polyethylene (PE) 470\u003c\/p\u003e \u003cp\u003e12.1.5.9 Polypropylene (PP) 473\u003c\/p\u003e \u003cp\u003e12.1.5.10 Polyethylene Terephthalate (PET) 478\u003c\/p\u003e \u003cp\u003e12.1.5.11 Polystyrene (PS) 478\u003c\/p\u003e \u003cp\u003e12.1.5.12 Polysulfone (PSf) 478\u003c\/p\u003e \u003cp\u003e12.1.5.13 Ethylene Vinyl Acetate (EVA) 480\u003c\/p\u003e \u003cp\u003e12.1.5.14 Multilayer Materials 482\u003c\/p\u003e \u003cp\u003e12.2 Heat Sterilization 483\u003c\/p\u003e \u003cp\u003e12.3 Residuals from Chemical Disinfection and Sterilization Agents 486\u003c\/p\u003e \u003cp\u003e12.3.1 Ethylene Oxide (EtO) 487\u003c\/p\u003e \u003cp\u003e12.3.2 Peracetic Acid and Hydrogen Peroxide 494\u003c\/p\u003e \u003cp\u003e12.3.3 Formaldehyde 497\u003c\/p\u003e \u003cp\u003eConcluding Remarks 503\u003c\/p\u003e \u003cp\u003eReferences 504\u003c\/p\u003e \u003cp\u003e\u003cb\u003e13 Biotechnological Products 512\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e13.1 DNA and HCP Residuals 516\u003c\/p\u003e \u003cp\u003e13.2 Viruses and Mycoplasma 516\u003c\/p\u003e \u003cp\u003e13.3 Endotoxin 518\u003c\/p\u003e \u003cp\u003e13.4 Protein Degradation 522\u003c\/p\u003e \u003cp\u003e13.5 Protein Aggregation 524\u003c\/p\u003e \u003cp\u003eConcluding Remarks 530\u003c\/p\u003e \u003cp\u003eReferences 530\u003c\/p\u003e \u003cp\u003e\u003cb\u003eAppendix Polymeric Materials: Components, Additives, Extractables, and Degradation Products 533\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003eReferences 553\u003c\/p\u003e \u003cp\u003eIndex 555\u003c\/p\u003e\u003c\/font\u003e\u003c\/p\u003e\r\n\r\n\u003cp\u003e\u003cfont size=\"3\"\u003eSubject Areas: Chemistry [\u003ca title=\"See our other books on Chemistry\" href=\"https:\/\/freshlyprintedbooks.co.uk\/search?q=%22Chemistry%20%5BPN%5D%22\"\u003ePN\u003c\/a\u003e]\u003c\/font\u003e\u003c\/p\u003e\r\n\r\n\r\n\u003c\/font\u003e","brand":"Wiley","offers":[{"title":"Brand 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