11. Microbiological and Endotoxin Contamination

  1. Denise Bohrer

Published Online: 5 OCT 2012

DOI: 10.1002/9781118449066.ch11

Sources of Contamination in Medicinal Products and Medical Devices

Sources of Contamination in Medicinal Products and Medical Devices

How to Cite

Bohrer, D. (2012) Microbiological and Endotoxin Contamination, in Sources of Contamination in Medicinal Products and Medical Devices, John Wiley & Sons, Inc., Hoboken, NJ, USA. doi: 10.1002/9781118449066.ch11

Author Information

  1. Federal University of Santa Maria, Santa Maria, Brazil

Publication History

  1. Published Online: 5 OCT 2012
  2. Published Print: 30 NOV 2012

ISBN Information

Print ISBN: 9780470487501

Online ISBN: 9781118449066

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Keywords:

  • microbiological contamination, and endotoxin contamination;
  • pharmaceuticals and microbial contamination;
  • microbial and manufactured product sterility level;
  • pharmaceuticals and microbiological quality, as per the BP;
  • JP, acceptance criteria for microbiological of nonsterile dosage;
  • microbial sources as extrinsic, allowing microbes into products;
  • water purification/microbial limits, sterile with preservatives;
  • compressed air system, contamination transporting microorganisms;
  • biofilm formation survival strategy, conventional methods as ineffective;
  • NNIS system, and nosocomial outbreaks as healthcare acquired

Summary

This chapter contains sections titled:

  • Water

  • Raw Materials

  • Sterile Products

  • Medicinal Gases

  • Medical Devices

  • Biofilms

  • Dialysis Circuits

  • nosocomial Infections

  • Concluding Remarks

  • References