Pharmaceutical Engineering is pleased to announce that the winner of the
2011-2012 Roger F. Sherwood Article of the Year Award is:
January/February 2012, Volume 32, Number 1
Risk Analysis and Mitigation Matrix (RAMM) – A Risk Tool for Quality Management ( 7 MB)
by Alex Brindle, Steve Davy, David Tiffany, and Chris Watts
This article presented a new type of risk tool. Risk Analysis and Mitigation Matrix (RAMM) was developed to be incorporated into a modern risk management system and align with latest FDA guidances.
The winner was recognized at ISPE’s 2012 Annual Meeting, 11-14 November in San Francisco, California, USA, and selected from the following group of finalists:
Volume 31, Number 5
Cleaning Validation for the 21st Century: Acceptance Limits for Active Pharmaceutical Ingredients (API’s): Part II ( 2 MB)
by Andrew Walsh
This article discussed how to establish true science-based limits using data from clinical and toxicological studies, a risk-based approach to evaluating cleaning validation data, and guidance on setting statistical process control limits from that data.
Volume 31, Number 6
Online Rouge Monitoring: A Science-Based Technology to Measure Rouge Rates ( 2 MB)
by Nissan Cohen and Allan Perkins
This article presented the implementation and installation of an online rouge monitor which measures in near real-time the rouge rate and rouge accumulation (metal loss) over time helping to determine derouging and passivation frequency based on empirical data.
Volume 32, Number 2
Application of Pre-Owned Equipment in Pharmaceutical Manufacturing Operations ( 1 MB)
by Stephan Sirabian, Bob Matje, Jeff Biskup, and Witold Lehmann
This article presented considerations to be made prior to making a capital investment in pre-owned equipment for new or refurbished pharmaceutical facilities.
Volume 32, Number 3
Pressure Pulse Approach for Optimized Tank Cooling after Steaming ( 2 MB)
by Magnus Stering, Olivier Chancel, and Luc Pisarik
This article presented an approach for faster cooling after steaming or after hot cleaning in place without the risk of generating vacuum inside the vessel and without the need for any large sized vent filter.
Volume 32, Number 4
The Use of Acceptable Daily Exposure (ADE’s) for Managing the Risk of Cross Contamination in Pharmaceutical Manufacturing ( 535 KB)
by Stephanie Wilkins and Julian Wilkins
This article presented a convincing justification for the use of Acceptable Daily Exposures (ADEs) to scientifically manage the risk of cross contamination in all types of bio/pharmaceutical facilities.
Indicates content available to ISPE members only.