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005 20171113131524.0
006 m o d
007 cr cnu---unuuu
008 121015s2012 nju ob 001 0 eng d
020 _a9781118449066
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020 _a1118449061
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020 _a9781118449080
_q(electronic bk.)
020 _a1118449088
_q(electronic bk.)
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020 _a1283645262
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020 _a9781118449059
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020 _a1118449053
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020 _z9780470487501
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082 0 4 _a338.4/76151
_223
100 1 _aBohrer, Denise.
245 1 0 _aSources of contamination in medicinal products and medical devices /
_cDenise Bohrer.
_h[electronic resource]
260 _aHoboken, N.J. :
_bWiley,
_c©2012.
300 _a1 online resource
336 _atext
_btxt
_2rdacontent
337 _acomputer
_bc
_2rdamedia
338 _aonline resource
_bcr
_2rdacarrier
504 _aIncludes bibliographical references and index.
505 0 _aTITLE 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
505 8 _a6.2 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
505 8 _aPART 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
505 8 _a13.2 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
520 _aContamination 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.
588 0 _aPrint version record.
650 0 _aMicrobial contamination.
650 0 _aPharmaceutical technology
_xStandards.
650 0 _aPharmaceutical industry
_xQuality control.
650 1 2 _aDrug Contamination.
650 2 2 _aEquipment Contamination.
650 2 2 _aEquipment and Supplies.
650 2 2 _aPharmaceutical Preparations
_xanalysis.
650 7 _aBUSINESS & ECONOMICS
_xIndustries
_xPharmaceutical & Biotechnology.
_2bisacsh
650 7 _aMicrobial contamination.
_2fast
_0(OCoLC)fst01019478
650 7 _aPharmaceutical industry
_xQuality control.
_2fast
_0(OCoLC)fst01060169
650 7 _aPharmaceutical technology
_xStandards.
_2fast
_0(OCoLC)fst01060216
655 4 _aElectronic books.
776 0 8 _iPrint version:
_aBohrer, Denise.
_tSources of contamination in medicinal products and medical devices.
_dHoboken, N.J. : Wiley, ©2012
_z9780470487501
_w(DLC) 2012017302
_w(OCoLC)796758837
856 4 0 _uhttp://onlinelibrary.wiley.com/book/10.1002/9781118449066
_zWiley Online Library
942 _2ddc
_cBK
999 _c206209
_d206209