Parenteral Quality Control: Sterility, Pyrogen, Particulate, and Package Integrity Testing (Drugs and the Pharmaceutical Sciences) Akers, Michael K.

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.…