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Validation of Pharmaceutical Processes: Sterile Products: Sterile Products, Second Edition - Hardcover

 
9780824793845: Validation of Pharmaceutical Processes: Sterile Products: Sterile Products, Second Edition
Hardcover
ISBN 10: 0824793846 ISBN 13: 9780824793845
Verlag: Marcel Dekker Inc, 1998

Inhaltsangabe

Featuring contributions from 25 specialists, this book provides a single-source reference on the design of systems, qualification of equipment, calibration and certification. It covers explicit procedures for the validation of systems required in the preparation of aseptic and nonaseptic pharmaceutical products. Topics include installation qualification, operational qualification, and change control, F, D, and Z values, steam sterilization-in-place technology and validation, sterilization methods, protocols that allow procedures to be applied directly, obstacles that may be encountered at any stage of the validation program, and suggested solutions.

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Verlag
Marcel Dekker Inc
Erscheinungsdatum
1998
Sprache
Englisch
ISBN 10 
0824793846
ISBN 13 
9780824793845
Einband
Gebundene Ausgabe
Anzahl der Seiten
864
Herausgeber
Carleton Frederick J., Agalloco James P.
Kontakt zum Hersteller
Nicht verfügbar
Verantwortliche Person
Nicht verfügbar