Parenteral quality control : sterility, pyrogen, particulate, and package integrity testing
著者
書誌事項
Parenteral quality control : sterility, pyrogen, particulate, and package integrity testing
（Drugs and the pharmaceutical sciences, v. 125）
Marcel Dekker, c2003
3rd ed., rev. and expanded
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注記
Includes bibliographical references and indexes
内容説明・目次
内容説明
Providing a well-written and easy-to-read review of the subject, this reference describes the most recent breakthroughs in the validation and execution of testing schemes for parenteral quality control. 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.
目次
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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