ISBN: 9780824708856 - parenteral quality control: sterility, pyrogen, particulate, and package integrity testing (4 risultati)

Hardcover. Condizione: 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.

Hardback. Condizione: Good. Condizione sovraccoperta: 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. …

Hardback. Condizione: 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.…

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