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003 | OCoLC | ||
005 | 20171113131524.0 | ||
006 | m o d | ||
007 | cr cnu---unuuu | ||
008 | 121015s2012 nju ob 001 0 eng d | ||
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_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. |
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300 | _a1 online resource | ||
336 |
_atext _btxt _2rdacontent |
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337 |
_acomputer _bc _2rdamedia |
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338 |
_aonline resource _bcr _2rdacarrier |
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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. |
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650 | 0 |
_aPharmaceutical industry _xQuality control. |
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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 |
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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 |
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999 |
_c206209 _d206209 |