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Sources of Contamination in Medicinal Products and Medical Devices

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Sources of Contamination in Medicinal Products and Medical Devices Cover

 

Synopses & Reviews

Publisher Comments:

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.

Synopsis:

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.

Synopsis:

Contamination in pharmaceutical manufacturing poses significant health risks, yet it is not fully addressed in existing compendia. This book provides for the first time a one-stop reference on the subject. It surveys the sources of contamination, explaining how to identify contaminants and impurities in pharmaceutical products, methods to avoid and remove contaminants, and regulatory guidelines to determine contamination. An absolute must for pharmaceutical and biotechnology researchers working in the area of quality control, as well as quality managers, regulators, chemists, and toxicologists in the field.

About the 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.

Table 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

ISBN:
9780470487501
Author:
Bohrer, Denise
Publisher:
John Wiley & Sons
Subject:
Chemistry - Technical & Industrial
Subject:
Pharmaceutical & Medicinal Chemistry
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Business Writing
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sources of contamination in medicinal products and medical devices, pharmaceutical contamination, pharmaceutical impurities, isolation and characterization of impurities in pharmaceuticals, pharmaceutical contamination control, pharmaceutical quality cont
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sources of contamination in medicinal products and medical devices, pharmaceutical contamination, pharmaceutical impurities, isolation and characterization of impurities in pharmaceuticals, pharmaceutical contamination control, pharmaceutical quality cont
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sources of contamination in medicinal products and medical devices, pharmaceutical contamination, pharmaceutical impurities, isolation and characterization of impurities in pharmaceuticals, pharmaceutical contamination control, pharmaceutical quality cont
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sources of contamination in medicinal products and medical devices, pharmaceutical contamination, pharmaceutical impurities, isolation and characterization of impurities in pharmaceuticals, pharmaceutical contamination control, pharmaceutical quality cont
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sources of contamination in medicinal products and medical devices, pharmaceutical contamination, pharmaceutical impurities, isolation and characterization of impurities in pharmaceuticals, pharmaceutical contamination control, pharmaceutical quality cont
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sources of contamination in medicinal products and medical devices, pharmaceutical contamination, pharmaceutical impurities, isolation and characterization of impurities in pharmaceuticals, pharmaceutical contamination control, pharmaceutical quality cont
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sources of contamination in medicinal products and medical devices, pharmaceutical contamination, pharmaceutical impurities, isolation and characterization of impurities in pharmaceuticals, pharmaceutical contamination control, pharmaceutical quality cont
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sources of contamination in medicinal products and medical devices, pharmaceutical contamination, pharmaceutical impurities, isolation and characterization of impurities in pharmaceuticals, pharmaceutical contamination control, pharmaceutical quality cont
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sources of contamination in medicinal products and medical devices, pharmaceutical contamination, pharmaceutical impurities, isolation and characterization of impurities in pharmaceuticals, pharmaceutical contamination control, pharmaceutical quality cont
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sources of contamination in medicinal products and medical devices, pharmaceutical contamination, pharmaceutical impurities, isolation and characterization of impurities in pharmaceuticals, pharmaceutical contamination control, pharmaceutical quality cont
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sources of contamination in medicinal products and medical devices, pharmaceutical contamination, pharmaceutical impurities, isolation and characterization of impurities in pharmaceuticals, pharmaceutical contamination control, pharmaceutical quality cont
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sources of contamination in medicinal products and medical devices, pharmaceutical contamination, pharmaceutical impurities, isolation and characterization of impurities in pharmaceuticals, pharmaceutical contamination control, pharmaceutical quality cont
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sources of contamination in medicinal products and medical devices, pharmaceutical contamination, pharmaceutical impurities, isolation and characterization of impurities in pharmaceuticals, pharmaceutical contamination control, pharmaceutical quality cont
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sources of contamination in medicinal products and medical devices, pharmaceutical contamination, pharmaceutical impurities, isolation and characterization of impurities in pharmaceuticals, pharmaceutical contamination control, pharmaceutical quality cont
Copyright:
Edition Description:
WOL online Book (not BRO)
Publication Date:
20121218
Binding:
HARDCOVER
Language:
English
Pages:
592
Dimensions:
231 x 167.5 x 36.9 mm 33.344 oz

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Sources of Contamination in Medicinal Products and Medical Devices New Hardcover
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Product details 592 pages John Wiley & Sons - English 9780470487501 Reviews:
"Synopsis" by , 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.

"Synopsis" by , Contamination in pharmaceutical manufacturing poses significant health risks, yet it is not fully addressed in existing compendia. This book provides for the first time a one-stop reference on the subject. It surveys the sources of contamination, explaining how to identify contaminants and impurities in pharmaceutical products, methods to avoid and remove contaminants, and regulatory guidelines to determine contamination. An absolute must for pharmaceutical and biotechnology researchers working in the area of quality control, as well as quality managers, regulators, chemists, and toxicologists in the field.
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