Bohrer, Denise. creator text bibliography Electronic books. nju Hoboken, N.J Wiley ©2012 2012 monographic eng

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1 online resource 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 Denise Bohrer. Includes bibliographical references and index. Microbial contamination Pharmaceutical technology Standards Pharmaceutical industry Quality control Drug Contamination Equipment Contamination Equipment and Supplies Pharmaceutical Preparations analysis BUSINESS & ECONOMICS Industries Pharmaceutical & Biotechnology Microbial contamination Pharmaceutical industry Quality control Pharmaceutical technology Standards RS192 .B64 2012eb 338.4/76151 QV 778 Bohrer, Denise. Hoboken, N.J. : Wiley, ©2012 (DLC) 2012017302 (OCoLC)796758837 9781118449066 1118449061 9781118449080 1118449088 9781283645263 1283645262 9781118449059 1118449053 EB00066888 Recorded Books 395776 MIL http://onlinelibrary.wiley.com/book/10.1002/9781118449066 http://onlinelibrary.wiley.com/book/10.1002/9781118449066 N$T 121015 20171113131524.0 ocn812914928 eng