Автор: Michael K. Akers, Dan Larrimore, Dana Guazzo
Название: Parenteral Quality Control: Sterility, Pyrogen, Particulate, and Package Integrity Testing
Издательство: CRC Press
Год: 2002
ISBN: 9780203910078
Серия: Drugs and the Pharmaceutical Sciences (Book 125)
Язык: English
Формат: pdf
Размер: 12,2 mb
Страниц: 408
Emphasize testing methodologies for the evaluation of package integrity, finished product contamination, and sterility, the book is a guide to testing and assuring that products for injecting drugs are sterile, free from pyrogenicity, and free from particulate matter. The authors highlight methods that meet US and European standards, explain regulatory requirements and harmonization between various authorities, and review trends and recent developments in technology.
Sterility Testing
Pyrogen Testing
Particulate Matter Testing
Package Integrity Testing
Appendix I Example of Standard Operating Procedure for Sterility Testing by Direct Inoculation
Appendix II Example of Standard Operating Procedure for Sterility Testing by Membrane Filtration
Appendix III Aseptic Procedures at the Laminar Flow Workbench
Index
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Parenteral Quality Control: Sterility, Pyrogen, Particulate, and Package Integrity Testing 
