Sources of Contamination in Medicinal Products and Medical Devices

Sources of Contamination in Medicinal Products and Medical Devices

By: Denise Bohrer (author)Hardback

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Description

The 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, including those originating from sterilization procedures. As 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: * Chemical contaminants including residual solvents, catalyst residuals, and genotoxic impurities in active pharmaceutical ingredients (APIs) * Diagnostic imaging agents (i.e., radiopharmaceuticals and contrast agents) * Microbiological and endotoxin contamination involving single and multiple dose products, medical devices, and biofilms * Contamination from sterilization procedures, residuals from radiation sterilization, ionizing radiation on packaging materials and medical devices * Medicinal gases and volatile anesthetics * Biopharmaceuticals including recombinant DNA technology products * Extractables and leachables from containers made of glass, plastics, and metal Each 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, Sources of Contamination in Medicinal Products and Medical Devices is essential to fully understanding the specific threats that undermine the safety of medicines and medical devices.

About Author

DENISE BOHRER, PhD, is Professor of Analytical Chemistry at the Federal University of Santa Maria, Brazil. Her research has focused on sources of contamination in pharmaceutical products, specifically, infusion solutions for patients with kidney disease and preterm infants. She has published sixty-eight papers and two book chapters on pharmaceutical manufacturing.

Contents

PREFACE xv ACKNOWLEDGMENTS xix 1 Introduction 1 Reference 6 2 Directives for Contamination Control 7 PART I CHEMICAL CONTAMINATION 17 3 Raw Materials 19 3.1 Water 19 3.2 Inorganic Impurities 27 3.3 Organic Impurities 32 3.3.1 By-products 32 3.3.2 Genotoxic Impurities (GTIs) 35 3.3.3 Degradation Products 39 3.4 Additives 52 3.5 Residual Solvents 58 Concluding Remarks 63 References 65 4 Medicinal Gases and Volatile Anesthetics 70 4.1 Medicinal Gases 70 4.2 Volatile Anesthetics 80 Concluding Remarks 93 References 94 5 Diagnostic Imaging Agents 96 5.1 Radiopharmaceuticals 98 5.1.1 Technetium-Based Products 100 5.1.1.1 Production of Mo-99 100 5.1.1.2 Generation of Tc-99m 103 5.1.1.3 Labeling Procedures 107 5.1.2 Iodine-Based Products 113 5.1.3 Fluorine-Based Products 125 5.1.3.1 [18F]FDG Production and Labeling 127 5.1.3.2 Species Formed during [18O]H2O Irradiation 128 5.1.3.3 Residual Solvents and Components Used in the Labeling 137 5.1.3.4 Radiolysis Products Generated by Elevated Activity of the Labeled Compound 140 5.2 Contrast Agents 143 5.2.1 Gadolinium-Based Products 143 5.2.2 Iodine-Based Products 158 5.2.3 Barium Sulfate 172 Concluding Remarks 176 References 177 6 Containers 185 6.1 Glass Containers 185 6.2 Plastic Containers 199 6.2.1 Polymer Formation 199 6.2.2 PVC Containers 203 6.2.3 Other Plastic Containers 215 6.3 Metal Containers 220 Concluding Remarks 223 References 223 7 Closures 228 Concluding Remarks 256 References 256 8 Delivery Systems and Filters 259 8.1 Delivery Systems Made of PVC 260 8.2 Delivery Systems Made of Other Plastic Materials 275 8.3 Filters 282 Concluding Remarks 287 References 287 9 Medical Devices 290 9.1 General Use Devices 293 9.1.1 Medical Gloves 294 9.1.2 Syringes 294 9.2 Extracorporeal Circuits 300 9.3 Devices for Administration of Aerosolized Drugs 307 9.4 Reprocessed Medical Devices 308 9.5 Tissue Substitutes 309 9.5.1 Skin Substitutes and Surgical Dressings 310 9.5.2 Hard Tissue Substitutes 310 9.5.3 Soft Tissue Substitutes 311 Concluding Remarks 313 References 313 PART II PHYSICAL CONTAMINATION 317 10 Particulate Matter 319 Concluding Remarks 345 References 345 PART III MICROBIOLOGICAL CONTAMINATION 349 11 Microbiological and Endotoxin Contamination 351 11.1 Water 355 11.2 Raw Materials 361 11.3 Sterile Products 367 11.3.1 Single- and Multiple-Dose Products 368 11.3.2 Parenteral Nutrition (PN) 371 11.3.3 Propofol 378 11.3.4 Ophthalmic Products 384 11.4 Medicinal Gases 393 11.5 Medical Devices 394 11.5.1 Syringes 395 11.5.2 Endoscopes 398 11.5.3 Other Devices 401 11.6 Biofilms 406 11.7 Dialysis Circuits 407 11.8 Nosocomial Infections 413 Concluding Remarks 420 References 422 PART IV MISCELLANEOUS 433 12 Contamination from Sterilization Procedures 435 12.1 Residuals from Radiation Sterilization 437 12.1.1 Radiolysis of Water 438 12.1.2 Effect of Ionizing Radiation on Drug Products 439 12.1.3 Polymers in Drug Delivery 440 12.1.3.1 Polylactide (PLA) and Poly(lactide-co-glycolide) (PLGA) 443 12.1.3.2 Collagen 448 12.1.3.3 Cellulose and Other Polysaccharides 448 12.1.3.4 Alginate 450 12.1.4 Radiolysis of Selected Nondrug Components 450 12.1.4.1 Residual Solvents 450 12.1.4.2 Monosaccharides 451 12.1.4.3 Starch 451 12.1.5 Effect of Ionizing Radiation on Materials Used in Packaging and in Medical Devices 454 12.1.5.1 Ultra-High-Molecular-Weight Polyethylene (UHMWPE) 456 12.1.5.2 Polyurethane (PU) 458 12.1.5.3 Silicone 464 12.1.5.4 Polyamide (PA) 464 12.1.5.5 Poly(methyl methacrylate) (PMMA) 466 12.1.5.6 Polytetrafl uoroethylene (PTFE) 468 12.1.5.7 Polyvinyl Chloride (PVC) 468 12.1.5.8 Polyethylene (PE) 470 12.1.5.9 Polypropylene (PP) 473 12.1.5.10 Polyethylene Terephthalate (PET) 478 12.1.5.11 Polystyrene (PS) 478 12.1.5.12 Polysulfone (PSf) 478 12.1.5.13 Ethylene Vinyl Acetate (EVA) 480 12.1.5.14 Multilayer Materials 482 12.2 Heat Sterilization 483 12.3 Residuals from Chemical Disinfection and Sterilization Agents 486 12.3.1 Ethylene Oxide (EtO) 487 12.3.2 Peracetic Acid and Hydrogen Peroxide 494 12.3.3 Formaldehyde 497 Concluding Remarks 503 References 504 13 Biotechnological Products 512 13.1 DNA and HCP Residuals 516 13.2 Viruses and Mycoplasma 516 13.3 Endotoxin 518 13.4 Protein Degradation 522 13.5 Protein Aggregation 524 Concluding Remarks 530 References 530 Appendix Polymeric Materials: Components, Additives, Extractables, and Degradation Products 533 References 553 INDEX 555

Product Details

  • ISBN13: 9780470487501
  • Format: Hardback
  • Number Of Pages: 592
  • ID: 9780470487501
  • weight: 950
  • ISBN10: 047048750X

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