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.

This is a preview of subscription content, log in to check access.

Access options

Buy single article

Instant unlimited access to the full article PDF.

US$ 39.95

Price includes VAT for USA

Subscribe to journal

Immediate online access to all issues from 2019. Subscription will auto renew annually.

US$ 189

This is the net price. Taxes to be calculated in checkout.

Author information

Correspondence to King C. Lee PhD, RAC.

Rights and permissions

Reprints and Permissions

About this article

Cite this article

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

Download citation

Key Words

  • Quality control
  • Biological products
  • Microbiological contamination