Volume 30, Number 5

Table of Contents

Articles

Lean Maintenance – A Risk-Based Approach

by Gerard Clarke, Gerry Mulryan, and Padraig Liggan
This article presents an industry case study of the application of lean maintenance methodologies carried out at the Pfizer Biotech, Grange Castle Campus, Dublin.

A Powder Handling Methodology in Pharmaceutical Manufacturing

by John D. Sherwood and Dr. Eddie McGee
This article presents a novel approach to designing pharmaceutical powder processing equipment.

Target Selection and Qualification – The Case of API Manufacturing Facilities

by Masatoshi Takemata, Mitsuyuki Nakajima, Toyohiko Takeda, Tomio Tsurugi, Kimihiro Imamura, Yoshifumi Hara, Norio Yanagisawa, and Naoki Matsumoto
This article proposes an approach for qualification target selection and demonstrates how this can be applied to API manufacturing facilities.

Executive Summary – Supply Chain Security: A Comprehensive and Practical Approach

This is a summary of a White Paper on “Supply Chain Security: A Comprehensive and Practical Approach” developed by members of the ISPE International Leadership Forum.

Challenges to Establishing External API Manufacturing in China

by Matteo Giovinazzi
This case study presents the establishment of a new multipurpose API plant by a major Chinese API manufacturer, supported by a major international pharmaceutical company.

Process Simulation Using VBA Code with Variable Input Data

by Stephen M. Hall, PE
This article explains how to use Visual Basic for Applications (VBA) code with variable input data to create a process simulation.

Departments

Global Regulatory News

ISPE Update - Discover “What's Next” at Annual Meeting - ISPE to Develop PQLI Guides - Pharmaceutical Engineering Now Accepting Articles for 2011 - ISPE-CCPIE China Conference 2010 to Focus on the Internationalization of China's Pharmaceutical Industry - Open Volunteer Positions - New to the Industry?

Classified Advertising with Advertiser’s Index

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