Articles by James E. Akers - Pharmaceutical Technology

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Articles by James E. Akers

James E. Akers


James E. Akers is the president of Akers Kennedy & Associates, PO Box 22562, Kansas City, MO 64113, akainckc@aol.com.

Articles
Overcoming Limitations of Vaporized Hydrogen Peroxide
September 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
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
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
April 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
August 2, 2010

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

The Myth Called "Sterility"
March 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
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
August 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
July 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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