Parenteral Quality Control: Sterility, Pyrogen, Particulate, and Package Integrity Testing

✍ Scribed by Michael K. Akers, Dan Larrimore, Dana Guazzo

Publisher: CRC Press
Year: 2002
Tongue: English
Leaves: 389
Series: Drugs and the Pharmaceutical Sciences
Category: Library

No coin nor oath required. For personal study only.

✦ Synopsis

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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