Articles liés à Parenteral Quality Control: Sterility, Pyrogen, Particulate,...
Parenteral Quality Control: Sterility, Pyrogen, Particulate, and Package Integrity Testing - Couverture rigide
Synopsis
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.
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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.
Les informations fournies dans la section « A propos du livre » peuvent faire référence à une autre édition de ce titre.
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Parenteral Quality Control: Sterility, Pyrogen, Particulate, and Package Integrity Testing (Drugs and the Pharmaceutical Sciences)
Edité par
CRC Press (edition 3), 2002
ISBN 10 : 0824708857
ISBN 13 : 9780824708856
Ancien ou d'occasion
Couverture rigide
Vendeur : BooksRun, Philadelphia, PA, Etats-Unis
Évaluation du vendeur 5 sur 5 étoiles
Hardcover. Etat : Very Good. 3. It's a well-cared-for item that has seen limited use. The item may show minor signs of wear. All the text is legible, with all pages included. It may have slight markings and/or highlighting. N° de réf. du vendeur 0824708857-11-1
Acheter D'occasion
EUR 38,87
Livraison gratuite
Expédition nationale : Etats-Unis
Expédition nationale : Etats-Unis
Quantité disponible : 1 disponible(s)
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Parenteral Quality Control: Sterility, Pyrogen, Particulate, and Package Integrity Testing (Drugs and the Pharmaceutical Sciences) Akers, Michael K.
Edité par
Marcel Dekker, New York, 2002
ISBN 10 : 0824708857
ISBN 13 : 9780824708856
Ancien ou d'occasion
Couverture rigide
Vendeur : Fox & Tome Books, Frederick, MD, Etats-Unis
Évaluation du vendeur 4 sur 5 étoiles
Hardback. Etat : Good. Etat de la jaquette : Good. Shows minor wear to the cover and pages. Pages have highlighting/margin notes/underlining or any combination. The binding is fully intact and secure. This is a good reading or studying copy and has been verified that all pages are legible. 100% satisfaction guaranteed! --- Michael K. Akers, Dan Larrimore and Dana Guazzo cover quality control testing of finished parenteral products in four main chapters: sterility testing, pyrogen testing, particulate matter testing and package integrity testing. The sterility chapter traces how the compendial test developed over time. It goes on to isolation chambers, robotic sterility test units, support procedures for sterility assurance and alternatives to the compendial test. Barrier isolation technology gets extended treatment, including how such systems are validated and the risk of false negatives when surface decontamination is used. The pyrogen chapter deals with the USP rabbit test, the Limulus amebocyte lysate test and modified versions of both. Throughout, the methods are aimed at meeting both U.S. and European requirements, and the text discusses how USP, EP, FDA and MCA expectations were brought closer together in the late 1990s. N° de réf. du vendeur OA-250202-shelf-36-015
Acheter D'occasion
EUR 41,29
Livraison gratuite
Expédition nationale : Etats-Unis
Expédition nationale : Etats-Unis
Quantité disponible : 1 disponible(s)
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Parenteral Quality Control: Sterility, Pyrogen, Particulate, and Package Integrity Testing (Drugs and the Pharmaceutical Sciences) Akers, Michael K.
Edité par
Marcel Dekker, New York, 2002
ISBN 10 : 0824708857
ISBN 13 : 9780824708856
Neuf
Couverture rigide
Vendeur : Fox & Tome Books, Frederick, MD, Etats-Unis
Évaluation du vendeur 4 sur 5 étoiles
Hardback. Etat : New. By Michael K. Akers, Dan Larrimore and Dana Guazzo, this is a working reference on the tests used to show that finished injectable products are sterile, free of pyrogens and free of particles. Separate long chapters cover sterility testing, pyrogen testing and particulate matter testing, and container package integrity is treated as well. The authors set the official compendial tests beside the debate over how reliable, sensitive and applicable they are. Throughout, they stress test methods that meet both U.S. and European requirements, along with newer technologies for testing the finished product. Considerable space goes to barrier isolation systems for sterility testing. It covers how to qualify and validate them, and the regulators' worry that surface decontamination inside an isolator can produce false-negative results. N° de réf. du vendeur OA-240306-shelf-29-027
Acheter neuf
EUR 84,15
Livraison gratuite
Expédition nationale : Etats-Unis
Expédition nationale : Etats-Unis
Quantité disponible : 1 disponible(s)
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Parenteral Quality Control: Sterility, Pyrogen, Particulate, and Package Integrity Testing (Drugs and the Pharmaceutical Sciences)
Vendeur : SHIMEDIA, Brooklyn, NY, Etats-Unis
Évaluation du vendeur 4 sur 5 étoiles
Etat : New. Satisfaction Guaranteed or your money back. N° de réf. du vendeur 0824708857
Acheter neuf
EUR 275,24
Livraison gratuite
Expédition nationale : Etats-Unis
Expédition nationale : Etats-Unis
Quantité disponible : 1 disponible(s)