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Author Clontz, Lucia.

Title Microbial limit and bioburden tests : validation approaches and global requirements / Lucia Clontz.

Publication Info. Boca Raton : CRC Press, [2009]
©2009

Copies

Location Call No. Status
 University of Saint Joseph: Pope Pius XII Library - Internet  WORLD WIDE WEB E-BOOK EBSCOEBC    Downloadable
University of Saint Joseph patrons, please click here to access this resource.
Edition Second edition.
Description 1 online resource (xv, 325 pages) : illustrations
Note Rev. ed. of: Microbial limit and bioburden tests for the pharmaceutical industry.
Bibliography Includes bibliographical references and index.
Contents Ch. 1. Microbial Life and Ecology -- Ch. 2. Microbial Contamination and Control -- Ch. 3. The USP Microbial Limit Tests -- Ch. 4. Pharmaceutical Waters -- Ch. 5. Environmental Monitoring -- Ch. 6. Bioburden Considerations in Equipment-Cleaning Validation -- Ch. 7. Method Validation and Media Suitability Testing -- Ch. 8. Microbiological Quality of Pharmaceutical and Biopharmaceutical Products and Raw Materials -- Ch. 9. Rapid Testing and Alternative Methods in Microbiology -- Ch. 10. Biofilms -- Ch. 11. Handling Aberrant and Out-of-Specification Microbial Data.
Note Description based on print version record.
GMD: electronic resource.
Subject Drugs -- Microbiology -- Standards.
Microbial contamination -- Measurement -- Standards.
Drug Industry -- standards.
Drug Contamination -- prevention & control.
Equipment Contamination -- prevention & control.
Microbiological Techniques.
Added Author Clontz, Lucia. Microbial limit and bioburden tests for the pharmaceutical industry.
Other Form: Print version: Clontz, Lucia. Microbial limit and bioburden tests. 2nd ed. Boca Raton : CRC Press, c2009 9781420053487 1420053485 (DLC) 2008033433 (OCoLC)148705294
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