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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.
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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.
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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.
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The updated edition of William Whyte's book provides information for novices and seasoned professionals alike.
Aug 2, 2010
By:
James E. Akers
The updated edition of William Whyte's book provides information for novices and seasoned professionals alike.
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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.
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The authors review the role of automation in aseptic processing and describe their experience in implementing advanced technologies, including the use of isolators and robotics.
May 1, 2009
By:
Yoshi Izumi, James E. Akers
The authors review the role of automation in aseptic processing and describe their experience in implementing advanced technologies, including the use of isolators and robotics.
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This article presents a study of an aseptic environmental monitoring system for surface contamination at critical areas using a robot.
Aug 2, 2007
By:
Mayumi Maruyama, Tomoo Matsuoka, Motonari Deguchi, James E. Akers
This article presents a study of an aseptic environmental monitoring system for surface contamination at critical areas using a robot.
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Sterile product manufacturing and related testing have evolved significantly during the last 30 years. From requirements for acceptance criteria for media-fill tests, to developing validated approaches for moist-heat sterilization, to the introduction of formalized sterility-testing practices, the pharmaceutical industry has made significant advances in testing and in key technology such as isolators, prefilled syringes, automation, and robotics. The author outlines the key regulatory and technical..
Jul 2, 2007
By:
James E. Akers
Sterile product manufacturing and related testing have evolved significantly during the last 30 years. From requirements for acceptance criteria for media-fill tests, to developing validated approaches for moist-heat sterilization, to the introduction of formalized sterility-testing practices, the pharmaceutical industry has made significant advances in testing and in key technology such as isolators, prefilled syringes, automation, and robotics. The author outlines the key regulatory and technical changes to sterile product manufacturing and takes a visionary look for the next era of sterile manufacturing marked by a greater emphasis on risk analysis.
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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
By:
James E. Akers, James P. Agalloco
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.
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