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.

Aseptic/Sterile Processing

Formulation and Drug Delivery

Process and Scaling

Manufacturing

Drug Development

Pharmaceutical Technology-04-02-2005

Pharmaceutical Technology

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.

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