Articles by James P. Agalloco - Pharmaceutical Technology

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Articles by James P. Agalloco

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

Apr 2, 2005

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.

Managing Aseptic Interventions

Mar 2, 2005

This article outlines a comprehensive approach for organizing a firm's aseptic operations, including planning for routine and nonroutine interventions, establishing effective process simulations, and determining which vials to incubate.

Aseptic Processing: A Review of Current Industry Practice

Oct 2, 2004

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.

Perspectives on Aseptic GuidanceA Critical Review of FDA's 2003 Draft Guidance and a Proposed Alternative

May 1, 2004

FDA's draft guidance on aseptic processing contains some inherent difficulties, including unrealistic expectations of sterility and microbial quantification, an absence of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.

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