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.

Drug Delivery

Aseptic/Sterile Processing

Formulation

Process Validation

Manufacturing

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