Articles by James P. Agalloco - Pharmaceutical Technology

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Articles by James P. Agalloco
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A More Rational Approach for Sterile Product Manufacturing

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.
May 1, 2012
By: James E. Akers, James P. Agalloco

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

The authors question certain aspects of the industry's current regulatory-compliance strategy and suggest that aseptic-process control and evaluation should be revised.
May 1, 2011
By: James E. Akers, James P. Agalloco

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

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.
Apr 2, 2011
By: James P. Agalloco, James E. Akers

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

The author describes why statistical significance would impose an unreasonable burden on manufacturers.
Feb 2, 2011
By: James P. Agalloco

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

The author explains the idea of equivalence and describes how it can facilitate equipment validation.
Dec 2, 2010
By: James P. Agalloco

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

The Myth Called "Sterility"

The authors propose a process-centric approach for carrying out aseptic-processing and suggest further dialogue. This articles contains bonus online-exclusive material.
Mar 1, 2010
By: James P. Agalloco, James E. Akers

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?

The author describes various manufacturing processes and evaluates whether the guidance can be applied to each of them.
May 1, 2009
By: James P. Agalloco

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

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.
Jul 2, 2008
By: James P. Agalloco

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.

Depyrogenation by Dilution

Feb 20, 2008
By: James P. Agalloco

Preparing sterile products requires manufacturers to control microbial quality. Sterility and endotoxin content are critical because failure to properly manage them can seriously harm, or even kill, patients.

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