Articles by James P. Agalloco - Pharmaceutical Technology

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Articles by James P. Agalloco

Depyrogenation by Dilution

Feb 20, 2008

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.

Innovation in Biological Indicator Evaluator Resistometer Vessel Technology

The authors examine advances in the design and the application of biological indicator evaluator resistometer vessels used to measure the resistance of bacterial spores in monitoring sterilization processes.
Aug 2, 2007

The authors examine advances in the design and the application of biological indicator evaluator resistometer vessels used to measure the resistance of bacterial spores in monitoring sterilization processes.

The Truth about Interventions In Aseptic Processing

Aseptic processing has advanced over the past several decades, yet the pharmaceutical industry is still accepting of its limitations, particularly as it relates to human intervention as a source of contamination. The authors explain the importance of further diminishing the role of operators in aseptic processing and the approaches and technologies needed to achieve that goal.
May 1, 2007

Aseptic processing has advanced over the past several decades, yet the pharmaceutical industry is still accepting of its limitations, particularly as it relates to human intervention as a source of contamination. The authors explain the importance of further diminishing the role of operators in aseptic processing and the approaches and technologies needed to achieve that goal.

Understanding Overkill Sterilization: An End to the Confusion

The author clarifies the definition and objectives of overkill sterilization for steam sterilization cycles. Current sterilization practices are reviewed and the validation difficulties associated with the various definitions of overkill sterilization are explored.
May 1, 2007

The author clarifies the definition and objectives of overkill sterilization for steam sterilization cycles. Current sterilization practices are reviewed and the validation difficulties associated with the various definitions of overkill sterilization are explored.

The Simplified Akers–Agalloco Method for Aseptic Processing Risk Analysis

This article summarizes changes to the Akers–Agalloco aseptic processing risk analysis model (first presented in Pharmaceutical Technology's November 2005 issue) as well as some of the underlying thinking behind the revision. The simplified model makes the method easier to use because of its greater flexibility of environmental control practice. It maintains the emphasis on human activity as the primary consideration in risk management for aseptic processing.
Jul 2, 2006

This article summarizes changes to the Akers–Agalloco aseptic processing risk analysis model (first presented in Pharmaceutical Technology's November 2005 issue) as well as some of the underlying thinking behind the revision. The simplified model makes the method easier to use because of its greater flexibility of environmental control practice. It maintains the emphasis on human activity as the primary consideration in risk management for aseptic processing.

Thinking Inside the Box: The Application of Isolation Technology forAseptic Processing

May 1, 2006

There are few, if any, valid reasons not to install an isolator in a new aseptic processing facility.

RABS and Advanced Aseptic Processing

May 1, 2006

Any aseptic processing technology that allows intervention by gowned personnel during operation cannot be considered an advanced technology. Although a standardized definition of restricted access barrier systems has been developed, these systems fall well short of being classfied as advanced technologies.

The Akers–Agalloco Method

Nov 2, 2005

The authors present a new approach to risk assessment for aseptic processing that emphasizes the contributions of personnel.

Aseptic Processing: A Vision of the Future

May 1, 2005

The complete elimination of human-derived contamination is possible only with the elimination of human intervention.

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