Articles by James E. Akers - Pharmaceutical Technology

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Articles by James E. Akers

Overcoming Limitations of Vaporized Hydrogen Peroxide

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

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

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

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

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.

A Commendable Cleanroom Compendium

The updated edition of William Whyte's book provides information for novices and seasoned professionals alike.
Aug 2, 2010

The updated edition of William Whyte's book provides information for novices and seasoned professionals alike.

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

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

The Impact of Automation on Aseptic Processing

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

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.

The Application of Robotics to Aseptic Environmental Surface Monitoring

This article presents a study of an aseptic environmental monitoring system for surface contamination at critical areas using a robot.
Aug 2, 2007

This article presents a study of an aseptic environmental monitoring system for surface contamination at critical areas using a robot.

Charting Process Improvement in Sterile Product Manufacturing

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

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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