rdf-syntax-grammar
mods:
  schema location: http://www.loc.gov/mods/v3 http://www.loc.gov/standards/mods/v3/mods-3-2.xsd
  title info:
    title: Sources of contamination in medicinal products and medical devices
  name:
    name part: Bohrer, Denise.
    role:
      role term: creator
  type of resource: text
  genre: bibliography
  genre: Electronic books.
  origin info:
    place:
      place term: nju
    place:
      place term: Hoboken, N.J
    publisher: Wiley
    date issued: ©2012
    date issued: 2012
    issuance: monographic
  language:
    language term: eng
  physical description:
    form: remote
    extent: 1 online resource
  abstract: 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.
  table of contents: 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.
  table of contents: 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.
  table of contents: 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.
  table of contents: 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.
  note: Denise Bohrer.
  note: Includes bibliographical references and index.
  subject:
    topic: Microbial contamination
  subject:
    topic: Pharmaceutical technology
    topic: Standards
  subject:
    topic: Pharmaceutical industry
    topic: Quality control
  subject:
    topic: Drugs
    topic: Microbiology
  subject:
    topic: Drug Contamination
  subject:
    topic: Equipment Contamination
  subject:
    topic: Equipment and Supplies
  subject:
    topic: Pharmaceutical Preparations
    topic: analysis
  classification: RS192 .B64 2012eb
  classification: 338.4/76151
  classification: QV 778
  related item:
    title info:
      title: Sources of contamination in medicinal products and medical devices
    name:
      name part: Bohrer, Denise.
    origin info:
      publisher: Hoboken, N.J. : Wiley, ©2012
    identifier: (DLC) 2012017302
  identifier: 9781118449066
  identifier: 1118449061
  identifier: 9781118449080
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  identifier: 9781283645263
  identifier: 1283645262
  identifier: 9781118449059
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  identifier: 9780470487501
  identifier: 047048750X
  identifier: 6613957763
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  identifier: EB00066888 Recorded Books
  identifier: 395776 MIL
  identifier: http://proxy.library.tamu.edu/login
  record info:
    record content source: NhCcYBP
    record creation date: 121015
    record change date: 20260215000044.7
    record identifier: in00005689391
    language of cataloging:
      language term: eng