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.


Risk Aversion Remains an Obstacle to Innovation in Closed Systems

Risk aversion is impeding the use of closed aseptic systems, and adding unnecessary cost and complexity to aseptic operations in the pharma industry.

Is the 2006 Technical Document Still Relevant for Today's Closed Aseptic Processing Equipment?

Questions and answers about contemporary closed-system design criteria for aseptic processing equipment

Straight Talk on Closed Aseptic Systems

The industry’s aversion to risk has led to its treating closed aseptic processing systems as miniature cleanrooms, resulting in redundant and expensive practices. This article ponders this impasse, examining new technologies and applications in light of past regulatory guidance and more than 40 years of operating evidence.