05732cam a2200805Ka 4500 ocn812914928 OCoLC 20171113131524.0 m o d cr cnu---unuuu 121015s2012 nju ob 001 0 eng d 9781118449066 (electronic bk.) 1118449061 (electronic bk.) 9781118449080 (electronic bk.) 1118449088 (electronic bk.) 9781283645263 (MyiLibrary) 1283645262 (MyiLibrary) 9781118449059 (electronic bk.) 1118449053 (electronic bk.) 9780470487501 047048750X 6613957763 9786613957764 EB00066888 Recorded Books AU@ 000050138895 AU@ 000052905744 CHBIS 009914460 CHVBK 162140290 DEBBG BV041053743 DEBSZ 431154813 NZ1 15916373 DEBBG BV043395116 (OCoLC)812914928 (OCoLC)813398308 (OCoLC)813535064 (OCoLC)815384664 (OCoLC)865012930 (OCoLC)869185528 (OCoLC)895715758 395776 MIL N$T eng pn N$T IDEBK E7B UIU EBLCP DG1 OCLCF UKDOC OCLCQ OCLCO CDX RECBK OCLCQ DEBSZ OCLCO CN3GA YDXCP MHW OCLCO OCLCQ OCLCO COO OCLCO OCLCQ OCLCO MAIN RS192 .B64 2012eb QV 778 BUS 070130 bisacsh 338.4/76151 23 Bohrer, Denise. Sources of contamination in medicinal products and medical devices / Denise Bohrer. [electronic resource] Hoboken, N.J. : Wiley, ©2012. 1 online resource text txt rdacontent computer c rdamedia online resource cr rdacarrier Includes bibliographical references and index. 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 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. Print version record. Microbial contamination. Pharmaceutical technology Standards. Pharmaceutical industry Quality control. Drug Contamination. Equipment Contamination. Equipment and Supplies. Pharmaceutical Preparations analysis. BUSINESS & ECONOMICS Industries Pharmaceutical & Biotechnology. bisacsh Microbial contamination. fast (OCoLC)fst01019478 Pharmaceutical industry Quality control. fast (OCoLC)fst01060169 Pharmaceutical technology Standards. fast (OCoLC)fst01060216 Electronic books. Print version: Bohrer, Denise. Sources of contamination in medicinal products and medical devices. Hoboken, N.J. : Wiley, ©2012 9780470487501 (DLC) 2012017302 (OCoLC)796758837 http://onlinelibrary.wiley.com/book/10.1002/9781118449066 Wiley Online Library ddc BK 206209 206209