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Akers, Michael J.

Parenteral quality control : sterility, pyrogen, particulate, and package integrity testing / Michael J. Akers, Daniel S. Larrimore, Dana Morton Guazzo. - 3rd ed. - New York : Marcel Dekker, c2003. - ix, 389 p. : ill. ; 24 cm. - Drugs and the pharmaceutical sciences ; v. 125 .

Includes bibliographical references and index.

1. Sterility testing --
2. Pyrogen testing --
3. Particulate matter testing --
4. Package integrity testing --
Appendixes: --
I. Example of standard operating procedure for sterility testing by direct inoculation --
II. Example of standard operating procedure for sterility testing by membrane filtration --
III. Aseptic procedures at the laminar flow workbench. TOC

Summary:
Describes the breakthroughs in the validation and execution of testing schemes for parenteral quality control. This book emphasize testing methodologies for the evaluation of package integrity, finished product contamination, and sterility. It explains regulatory requirements and harmonization between various authorities.



ISBN: 0824708857 (alk. paper) 9780824708856

LCCN: 2002035194

Subjects--Topical Terms:
Parenteral solutions--Analysis.
Parenteral solutions--Standards.
Pharmaceutical industry--Quality control.

LC Class. No.: RS201.P37 / A54 2003

Dewey Class. No.: 615.19 / AKP 2003