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

Akers, Michael J.; Guazzo, Dana Morton

Couverture rigide

ISBN 10 : 082479088X ISBN 13 : 9780824790882

Editeur : Marcel Dekker Inc, 1993

Synopsis

This second edition details current methods of testing parenteral quality control and discusses new techniques and emerging trends. It combines principles with practical information on how the tests are conducted, their strengths and limitations, and possible forthcoming changes. Coverage includes global testing requirements; new issues and approaches involving retesting of lots that failed initial sterility tests; and new technologies such as barrier systems for conducting sterility testing.

A propos du livre

Présentation de l'éditeur

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.

Détails de l'édition

• Éditeur: Marcel Dekker Inc
• Date d'édition: 1993
• Langue: anglais
• ISBN 10: 082479088X
• ISBN 13: 9780824790882
• Reliure: Relié
• Nombre de pages: 400
• Coordonnées du fabricant: non disponible
• Personne responsable: non disponible