Sources of contamination in medicinal products and medical devices /

Sources of contamination in medicinal products and medical devices /

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 impuritie...

Πλήρης περιγραφή

Λεπτομέρειες βιβλιογραφικής εγγραφής
Κύριος συγγραφέας: Bohrer, Denise
Μορφή: Ηλ. βιβλίο
Γλώσσα:English
Έκδοση: Hoboken, N.J. : Wiley, [2012]
Θέματα:
Microbial contamination.
Pharmaceutical technology > Standards.
Pharmaceutical industry > Quality control.
Drug Contamination.
Equipment Contamination.
Equipment and Supplies.
Pharmaceutical Preparations > analysis.
BUSINESS & ECONOMICS > Industries > Pharmaceutical & Biotechnology.
Electronic books.
Διαθέσιμο Online:Full Text via HEAL-Link
Πίνακας περιεχομένων:
  • 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

Παρόμοια τεκμήρια