Quality Control Issues Related to Biological Products: Microbial Contamination


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.

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Correspondence to King C. Lee PhD, RAC.

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Lee, K.C., Toksoy, L. Quality Control Issues Related to Biological Products: Microbial Contamination. Ther Innov Regul Sci 36, 631–634 (2002). https://doi.org/10.1177/009286150203600317

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Key Words

  • Quality control
  • Biological products
  • Microbiological contamination