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Parenteral Quality Control
Sterility, Pyrogen, Particulate, and Package Integrity Testing
Seiten
2002
|
3rd New edition
Marcel Dekker Inc (Verlag)
978-0-8247-0885-6 (ISBN)
Marcel Dekker Inc (Verlag)
978-0-8247-0885-6 (ISBN)
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Describes the breakthroughs in the validation and execution of testing schemes for parenteral quality control. This book emphasize testing methodologies for the evaluation of package integrity, finished product contamination, and sterility. It explains regulatory requirements and harmonization between various authorities.
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.
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.
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
Erscheint lt. Verlag | 20.11.2002 |
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Reihe/Serie | Drugs and the Pharmaceutical Sciences |
Verlagsort | New York |
Sprache | englisch |
Maße | 152 x 229 mm |
Gewicht | 703 g |
Themenwelt | Medizin / Pharmazie ► Medizinische Fachgebiete ► Pharmakologie / Pharmakotherapie |
Studium ► 1. Studienabschnitt (Vorklinik) ► Histologie / Embryologie | |
Technik | |
ISBN-10 | 0-8247-0885-7 / 0824708857 |
ISBN-13 | 978-0-8247-0885-6 / 9780824708856 |
Zustand | Neuware |
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