Volume 29, Number 4 Table of Contents Articles Design of Pure Steam Generation and Distribution Systems by Hugh Hodkinson This article presents an overview of design requirements of pharmaceutical pure steam generation...

Volume 29, Number 3 Table of Contents Articles The FDA’s Draft Process Validation Guidance – A Perspective from Industry This article provides an overview of the draft guidance, the key changes in relation to the 1987...

PAT and Green Chemistry: The Intersection of Benign by Design and Quality by Design by Berkeley W. Cue, John Berridge, Julie B. Manley This article will illustrate the application of Process Analytical Technology (PAT)...

Volume 29, Number 1 Table of Contents Articles Online Total Organic Carbon (TOC) as a Process Analytical Technology for Cleaning Validation Risk Management by Keith Bader, John Hyde, Peter Watler, Amber Lane This article...

Volume 28, Number 6 Table of Contents Articles Evaluation of Electron Beam (E-Beam) Sterilization Technology for Filling of Drug Products in Pre-Filled Syringes (PFS) by Xiaogang Pan, Xiangning Deng, Michael Lee, Thomas...

Volume 28, Number 5 Table of Contents Articles Functional Safety in the Life Science Industries by David Hatch, Iwan van Beurden, Eric W. Scharpf, Iwan van Beurden, David Hatch, Eric W. Scharpf This article presents an...

Volume 28, Number 4 Table of Contents Articles Increased Process Understanding Through Monitoring and Scale-Down Models: Case Study of a Cell Culture Harvest Fluid Titration and Filtration Process by Kurt Yanagimachi...

Volume 28, Number 3 Table of Contents Articles A Risk-Based Approach to Cleaning Validation using Visible Residue Limits by Richard J. Forsyth, Jeffrey L. Hartman This article describes the development of a Visible...

Volume 28, Number 2 Table of Contents Articles Biopharmaceutical Process Characterization: Defining the Design Space by Anthony Newcombe, Keith Watson, Claire Newcombe This article presents an overview of the current...

Volume 28, Number 1 Table of Contents Articles How Smart Is Your On-Line TOC Analyzer? by Nissan Cohen, Terry Stange This article presents the development and integration of an Ultraviolet (UV) sensor for on-line TOC...

Volume 27, Number 6 Table of Contents Articles PAT and QbD – Effects on 21st Century Laboratories in Development and Manufacturing by Alex Brindle, Line Lundsberg-Nielsen This article discusses the influence of PAT and...

Volume 27, Number 5 Table of Contents Articles Using Technology Transfer to Maximize Business Efficiency by Russ Somma This article presents a technology transfer approach that can help prevent costly delays, leverage...

Volume 27, Number 4 Table of Contents Articles Outsourcing and Contract Manufacturing in the Pharmaceutical Industry by Magdalena Nannei, Sandra Rumiano This article reviews the considerations involved to decide whether...

Volume 27, Number 3 Table of Contents Articles Testing by Roy F. Greenwald, Thys Smit This article describes the tremendous variability in requirements for testing and final acceptance of process skids and suggests...

Volume 27, Number 2 Table of Contents Articles Eight Steps to PAT: Using the Design for Lean Six Sigma Toll-Gate Process as Best Practice by Bikash Chatterjee, Jeremy Green This article outlines an eight-step six Sigma...

Volume 27, Number 1 Table of Contents Articles NIR spectrometry for the characterization of fuel components in a novel tamper-resistant pill bottle Choosing Technologies for Aseptic Filling: “Back to the Future by James...

Volume 26, Number 6 Table of Contents Articles Quality by Design, Validation, and PAT: Operational, Statistical, and Engineering Perspectives by Ron Branning, Lynn Torbeck, Cliff Campbell This article demonstrates how...

Volume 26, Number 5 Table of Contents Articles Biotech CIP Cycle Development: Case Study Examples Utilizing QRM by Matt Wiencek This article presents case study examples of CIP cycle development activities and lessons...