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Quality Control Issues Related to Biological Products: Microbial Contamination

  • King C. LeeEmail author
  • Leyla Toksoy
Article

Abstract

This article describes the source, methods of detection, and methods of elimination of microbial contamination. The three possible origins of microbial contaminants are: cross, environmental, and commonly-known microbial contaminants. Many tests can be used to detect microbial contamination; however, some should be modified to allow sensitive detection of microbial contamination in the presence of a large quantity of biological products. To avoid microbial contamination, institute features in the facility design to control contamination; dedicate equipment and the production suite to the specific biological product; use a Class 100 laminar flow hood for the downstream production process; sterilize all equipment, growth medium, and packing materials; conduct integrity testing of the sterilization filters before and after production; perform in-process controls to prevent or identify contaminants; and monitor the environment and personnel.

Key Words

Quality control Biological products Microbiological contamination 

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Copyright information

© Drug Information Association, Inc 2002

Authors and Affiliations

  1. 1.Regulatory AffairsAton Pharma, Inc.TarrytownUSA
  2. 2.Vion Pharmaceuticals, Inc.New HavenUSA

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