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
By:
James E. Akers, James P. Agalloco
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.
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May 1, 2006
By:
James E. Akers, Mamoru Kokubo, Yasusuke Oshima
The industry has acknowledged only recently the significance of the
contamination risk posed by humans. The authors assert that this
realization, together with technological advances, will lead to the
elimination of human intervention and, hence, improved
sterility.
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May 1, 2006
By:
James P. Agalloco, James E. Akers
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.
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Nov 2, 2005
By:
James E. Akers, James P. Agalloco
The authors present a new approach to risk assessment for aseptic processing that emphasizes the contributions of personnel.
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May 1, 2005
By:
James P. Agalloco, James E. Akers
The complete elimination of human-derived contamination is possible only with the elimination of human intervention.
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