Includes bibliographical references and index.

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.

TITLE PAGE; COPYRIGHT PAGE; QUOTATION; DEDICATION; 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; 3.4 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 PLASTIC CONTAINERS6.3 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; 9.2 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 CONTAMINATION11 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 AND STERILIZATION AGENTS; CONCLUDING REMARKS; REFERENCES; 13 BIOTECHNOLOGICAL PRODUCTS; 13.1 DNA AND HCP RESIDUALS

13.2 VIRUSES AND MYCOPLASMA13.3 ENDOTOXIN; 13.4 PROTEIN DEGRADATION; 13.5 PROTEIN AGGREGATION; CONCLUDING REMARKS; REFERENCES; APPENDIX: POLYMERIC MATERIALS: COMPONENTS, ADDITIVES, EXTRACTABLES, AND DEGRADATION PRODUCTS; REFERENCES; INDEX

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