May / June 2010 Cover


Volume 30, Number 3

Table of Contents


Simple Strategies to Improve Bioprocess Pure Culture Processing

by Michael Hines, Chris Holmes, and Ryan Schad
This article presents strategies to improve bioreactions by reducing contaminations by adventitious agents.

A Methodology for Knowledge Management in Biopharmaceutical Production

by Jennifer Coakley, Nicola Hogan, Linda McGuire, Brendan Griffin, Colman Casey, Cliff Campbell, and Abina Crean
This article presents a novel ontological, stepwise approach undertaken to itemize and standardize a biopharmaceutical manufacturing process into a multidisciplinary plant and process knowledge model.

An Exhausting Solution for Fermentors

by Ernest L. Stadler
This article provides various solutions from simple to complex that deal with the removal of water vapor, liquid particles, and solid particles that can escape a fermentor exhaust nozzle and clog the sterile exhaust filter.

Guide for using Open Source Software (OSS) in Regulated Industries based on GAMP

by Markus Kaufmann, Marcus Ciolkowski, Andreas Hengstberger, Till Jostes, Erwin Kruschitz, Thomas Makait, Karl-Heinz Menges, Stefan Münch, and Martín Soto
This article demonstrates the benefits of employing Open Source Software (OSS) in compliance with GAMP for the validation of computerized pharmaceutical applications.

Successful Use of Simulation as a Tool in a Lean Six Sigma Program

by Bruce Sawyer, Johnny Muñoz, and Jim Curry
This article presents the role of simulation in Johnson & Johnson’s process excellence program. It uses a case study of a large pharmaceutical plant to describe how simulation evolved from improvement and capacity projects to the ongoing planning and management process.

A Simplified Statistical Model to Assess Product Capability

by Selim Seyhan, Tolga Özcan, and Merve Öktem
This article presents a simplified model that can be used after future refinements to identify the specific process capability in pharmaceutical manufacturing. Data for a concrete production stage of a solid product is presented. Technologies, present and future, are identified.

Systems Turnover Coordination: Effective Application and Integration of the Supplier-Provided Engineering Turnover Package (ETOP)

by Carol Susla
This article presents the process for leveraging supplier knowledge and documentation in the context of applying a risk-based approach to compliant commissioning and qualification programs.


2010 May/June FOYA Supplement


ISPE Update - ISPE Milan Congress Report: Cooperation, Collaboration, and Harmonization - ISPE Launches Career Solutions - ISPE International Board Member Appointed VP with GMS - Philippines Affiliate Welcomes Best - India Affiliate’s Young Pharmaceutical Professionals’ Educational Program a Success 

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