Articles by James P. Agalloco - Pharmaceutical Technology

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Articles by James P. Agalloco

James P. Agalloco


James P. Agalloco is the president of Agalloco & Associates, P.O. Box 899, Belle Mead, NJ 08502, tel. 908.874.7558,

Overcoming Limitations of Vaporized Hydrogen Peroxide
September 2, 2013

Vaporous hydrogen peroxide, used for sterilization and decontamination, is highly potent but presents implementation challenges.

A More Rational Approach for Sterile Product Manufacturing
May 1, 2012

The authors assert that the current gulf between aseptic processing and terminal sterilization can be bridged by re-examining fundamental regulatory philosophies for sterile-product manufacturing.

Regulation of Aseptic Processing in the 21st Century
May 1, 2011

The authors question certain aspects of the industry's current regulatory-compliance strategy and suggest that aseptic-process control and evaluation should be revised.

Revisiting Interventions in Aseptic Processing
April 2, 2011

The authors revisit their previous effort to refine the terms that describe interventions and to dispel confusion that arose after the original article was published.

Risk-Based Thinking in Process Validation
February 2, 2011

The author describes why statistical significance would impose an unreasonable burden on manufacturers.

The Importance of Equivalence in the Execution and Maintenance of Validation Activities
December 2, 2010

The author explains the idea of equivalence and describes how it can facilitate equipment validation.

The Myth Called "Sterility"
March 1, 2010

The authors propose a process-centric approach for carrying out aseptic-processing and suggest further dialogue. This articles contains bonus online-exclusive material.

FDA's Draft Guidance for Process Validation: Can It Be Applied Universally?
May 1, 2009

The author describes various manufacturing processes and evaluates whether the guidance can be applied to each of them.

Compliance Risk Management Using a Top-Down Validation Approach
July 2, 2008

Patient safety must be the primary concern of any validation effort. The author explains how a risk-based approach to validation and compliance follows naturally from this premise.


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