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.

James P. Agalloco

Articles

The authors review current industry practices and regulatory expectations for the aseptic processing of sterile drugs. They compare and outline critical issues in current manufacturing technology and capabilities with regulatory requirements.

Aseptic Processing: A Review of Current Industry Practice

FDA's draft guidance on aseptic processing contains some inherent difficulties, including unrealistic expectations of sterility and microbial quantification, an absence of harmonization with international rules, and failure to support new technologies or a risk-based approach. The authors propose a science-based alternative.

Perspectives on Aseptic Guidance A Critical Review of FDA's 2003 Draft Guidance and a Proposed Alternative

In the concluding part of this article, the authors address diffusive-airflow imprecisions and measurements as well as automated integrity-test equipment, variations in bubble-point measurements, and the identification of a "sterilizing" filter.

Filter Integrity Testing in Liquid Applications, Revisited Part II

In Part I of this article, the authors summarize the principles of various integrity tests, including their performance and purpose.