Importance of Background Microbial Levels in the Manufacture and Testing of Sterile Products

April 2, 2005
James P. Agalloco

James P. Agalloco is the president of Agalloco & Associates, P.O. Box 899, Belle Mead, NJ 08502, tel. 908.874.7558, jagalloco@aol.com. He is also a member of Pharmaceutical Technology’s editorial advisory board.

Pharmaceutical Technology, Pharmaceutical Technology-04-02-2005, Volume 29, Issue 4

The sterility testing of samples from an aseptic process may be considered an entirely separate aseptic process that is subject to the same types of adventitious contamination as the aseptic process itself.