Sources of Contamination in Medicinal Products and Medical Devices

Informationen zum Autor 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. Klappentext The first one-volume guide to sources of contamination in pharmaceuticals and medical devicesMost 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 metalEach 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. Zusammenfassung 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. Inhaltsverzeichnis 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 L...

List of contents

1. Introduction
 
2. Directives for contamination control
 
PART I: CHEMICAL CONTAMINATION
 
3. Raw Materials
 
3.1 Water
 
3.2 Inorganic Impurities
 
3.3 Organic Impurities
 
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
 
1. Introduction
 
2. Directives for contamination control
 
PART I: CHEMICAL CONTAMINATION
 
3. Raw Materials
 
3.1 Water
 
3.2 Inorganic Impurities
 
3.3 Organic Impurities
 
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
 
5.2 Contrast agents
 
Concluding remarks
 
References
 
6. Containers
 
6.1 Glass containers
 
6.2 Plastics 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 remarks
 
References
 
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
 
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 materials
 
11.3 Sterile products
 
11.4 Medicinal gases
 
11.5 Medical 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
 
12.2 Heat sterilization
 
12.3 Residuals from chemical disinfection/sterilization agents
 
Concluding remarks
 
References
 
13. Biotechnological products
 
13.1 DNA and Host cell proteins residuals
 
13.2 Viruses and mycoplasma
 
13.3 Endotoxin
 
13.4 Protein degradation
 
13.5 Protein aggregation
 
Concluding remarks
 
References
 
Appendix

Product details

• Authors: Bohrer, D Bohrer, Denise Bohrer, Bohrer Denise
• Publisher: Wiley, John and Sons Ltd
• Languages: English
• Product format: Hardback
• Released: 11.12.2012
• EAN: 9780470487501
• ISBN: 978-0-470-48750-1
• No. of pages: 592
• Subjects: Natural sciences, medicine, IT, technology > Chemistry > Miscellaneous; Social sciences, law, business > Business > Individual industrial sectors, branches; Chemie, Medizin, Analytische Chemie, Kontamination, chemistry, Analytical Chemistry, Pharmacology & Pharmaceutical Medicine, Pharmakologie u. Pharmazeutische Medizin, Medical Science, Pharmaceutical & Medicinal Chemistry, Pharmazeutische u. Medizinische Chemie, PHARMAZEUTISCHE CHEMIE