Volume 26, Number 4

Table of Contents

Articles

A Holistic Analysis of Pharmaceutical Manufacturing and Distribution: Are Conventional Supply Chain Techniques Appropriate?

by Christopher J. Savage, Kevin J. Roberts, Xue Z. Wang
This article evaluates the post-discovery supply chain to determine whether it can be evaluated by conventional analytical methods and improved by the application of supply chain techniques. It considers the impact of factors, including changes in legislation and drug delivery methods.

Operational Considerations of Thermally Sensitive Healthcare Products

by Sanford L. Cook
This article discusses the need for special procedures starting at receipt of sensitive components/ingredients, through operations and distribution, including requirements and new packaging supplies for temperature sensitive medical products.

Quantifying the Impact of Uncertain Parameters in the Batch Manufacturing of Active Pharmaceutical Ingredients

by Evdokia C. Achilleos, John C. Calandranis, Demetri P. Petrides
This article presents a risk assessment technique used to quantify the impact of uncertainty and variability in the manufacturing of bulk pharmaceuticals.

Containment Performance of a New Docking Station

by Hiroto Masuda, Yukio Fukushima, Satoru Hasegawa, Tadatoshi Iwabuchi, 
This article presents a research project conducted by Hitachi and Elveco on a docking station patented by Elveco and licensed to Hitachi Plant Technologies for East Asia. It describes how the ISPE Good Practice Guide: Assessing the Particulate Performance of Pharmaceutical Equipment was used throughout the project.

Interview with Bernardus (Ben) N.M. Machielse, Drs., Senior Vice President Operations, MedImmune Inc

This interview presents a candid look at MedImmune's Operational Excellence Program, including how they are implementing lean manufacturing (Six Sigma) in all aspects of their operations as a framework for continuous improvement. 

Design, Qualification, and Performance of a Cost-Effective Water Purification System for a GMP Pilot Plant 

by Joseph Tunner, George Katsoulis, Jeffrey Denoncourt, Sean Murphy
This article describes a water purification system for a GMP pilot plant that uses modular, off-the-shelf purification components chosen to control cost, maximize validation efficiency, and meet USP requirements for purified water.

Debottlenecking of a Batch Pharmaceutical Cream Production

by Jully Tan, Dominic Chwan Yee Foo, Sivakumar Kumaresan, Ramlan Abdul Aziz
This article describes the use of a batch process simulator in the modelling and debottlenecking of an anti-allergic cream production line at an existing pharmaceutical facility.

Departments

New Products and Literature

Industry and People

ISPE Update

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