Pharmaceutical Engineering Announces Winner of the 2014 Roger F. Sherwood Article of the Year Award
July/August 2014, Volume 34, Number 4
Chemical and Media-Free Pretreatment for Biopharma RO – Electrolysis for Scale Precipitation and UV Dechlorination ( 2 MB)
by Nissan Cohen and Shlomo Sackstein
This article identifies the issues plaguing water systems with Reverse Osmosis (RO) and defines the proper criteria of operation.
Pharmaceutical Engineering’s “Article of the Year” recognizes the contribution of authors and articles are evaluated by a panel of volunteer reviewers according to a number of criteria including: applicability, timeliness, relevancy, quality of content, and presentation.
The winner was recognized at ISPE’s 2014 Annual Meeting in Las Vegas, Nevada, USA, and selected from the following group of finalists:
A Review of Regulations and Developments in GMP and Supply Chain Integrity of Active Pharmaceutical Ingredients
by Sia Chong Hock, Katherine Loh Kai Xin, Vimal Sachdeva, and Chan Lai Wah
This article presents an overview of the current regulations and developments in good manufacturing practices and supply chain integrity of active pharmaceutical ingredients, and analyzes the challenges faced by regulatory authorities and industry.
Steam Sterilization Principles
by Marcel Dion and Wayne Parker
This article presents how a good understanding of basic steam sterilization principles can help with avoiding most common mistakes made when using steam autoclaves.
Evaluation of Controlled Manufacturing Environments following an Air Handling Unit Shutdown
by Catherine E. Anderson and Brian J. Lloyd, PhD
This article provides a methodology to evaluate the environmental impact of an air handling unit shutdown in a GMP manufacturing environment.
Applying a Consistent, Compliant, and Practical Risk-Based Validation Process for Laboratory Systems
by Anil K. Rattan, PhD and Michael Rubacha
This article presents a consistent, compliant and practical risk-based validation process for laboratory systems.
A Changing Landscape: Perspectives on Temperature Management for the Distribution of Non-Refrigerated Clinical Supplies Description
by Dr. Nicole Assfalg, Ted Bradley, Tim Brewer, Sébastien Delporte, Kristen DeVito, Bruce Guenter, and Patricia Thomas
This article discusses the shipment of room temperature products from several perspectives: the changing regulatory environment, risk assessment and mitigation, new technologies and budgetary pressures.
Indicates content available to ISPE members only.