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Pharmaceutical Quality Control Reference
from C.H.I.P.S.

Handbook of Microbiological Quality Control
Pharmaceuticals
and Medical Devices
edited by Raymond Baird
Norman Hodges
Stephen Denyer

The Handbook of Microbiological Quality Control provides a unique distillation of such material, by providing a wealth of microbiological information not only on the practical issues facing the company microbiologist today, but also the underlying principles of microbiological quality assurance. All the chapters have been written by leading experts in this field.

This reference provides guidance on safe microbiological practices, including laboratory design and sampling techniques. The design storage, use and quality control of microbiological culture is considered in depth. Principles of enumeration and identification of micro-organisms, using both traditional and rapid methods as well as the pharmacopoeial methods for the detection of specified organisms, are elaborated in detail. Guidance is given on laboratory methods supporting the sterility assurance system: sterility testing, bioburden testing, the use of biological indicators and environmental monitoring methods, as well as methods for detecting and quantifying endotoxins. Pharmacopoeial methods for microbiological assay and preservative efficacy testing are reviewed. Problems for those involved in disinfection and cleansing techniques and microbiological audit are discussed from a practical viewpoint. Finally, a number of pertinent case studies and worked examples illustrate problems highlighted in the text.

The Handbook of Microbiological Quality Control is the essential reference source for the professional microbiologist.

Contents

  1. Safety in Microbiology
  2. Culture Media
  3. Sampling
  4. Enumeration of Micro-organisms
  5. Identification of Micro-organisms
  6. Specified Organisms
  7. Rapid Methods
  8. Sterility Assurance
  9. Endotoxin Testing
  10. Preservative Efficacy Testing
  11. Microbiological Assay
  12. Disinfection and Cleansing
  13. Microbiological Audit
  14. Case Studies and Calculations

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Handbook of Microbiological Quality Control:
Pharmaceuticals and Medical Devices

edited by Raymond Baird, Norman Hodges
and Stephen Denyer

276 pages $178.95 + shipping
Texas residents please add 6.75 % sales tax

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