Michael K Akers (7 results)

Hardcover. Condition: 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. Condition: 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! --- Part of Marcel Dekker's Drugs and the Pharmaceutical Sciences series, this 2003 volume by Michael J. Akers, Daniel Larrimore, and Dana Morton Guazzo addresses the quality control procedures used to verify that injectable pharmaceuticals are sterile, nonpyrogenic, and free of particulate contamination. The text examines validation strategies and analytical approaches for assessing finished product contamination, container closure integrity, and microbial sterility, while reviewing the regulatory frameworks of both US and European authorities and efforts toward international harmonization. It serves as a technical reference for professionals engaged in parenteral manufacturing, quality assurance, and compliance. …

Hardback. Condition: New. The third edition, revised and expanded, of a reference work on quality control testing for parenteral pharmaceuticals - drug products administered by injection. Issued as Volume 125 in the Drugs and the Pharmaceutical Sciences series, the book addresses the analysis and standards of parenteral solutions and quality control within the pharmaceutical industry, organised around the four testing areas named in the subtitle: sterility, pyrogen, particulate matter, and package integrity. New material in this edition includes an expanded treatment of barrier isolation technology, which has become the standard in sterility testing, together with discussion of industry expectations for qualification of such systems in finished-product sterility testing. The authors examine regulatory concerns over false-negative results arising from surface decontamination within barrier isolation systems, and set out methods for validating such systems, while the chapter on package integrity testing has been updated to address recent developments in the technology, with updated references throughout. Includes bibliographical references and index.…

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Condition: New. pp. 300.

Condition: New. pp. 300.

Condition: New. pp. 300 Illus. This item is printed on demand.