November/December 2013
Volume 33, Number 6

NOTE: Pharmaceutical Engineering article PDF documents are not to be posted on any Web site, blog site or page, or any other internet site without prior permission from ISPE. (Copyright © 2013 ISPE. All rights reserved.)


 

Regulatory Compliance

Cleaning Validation for the 21st Century: Acceptance Limits for Cleaning Agents
by Andrew Walsh, MS, Mohammad Ovais, MP, Thomas Altmann, Gr FC, and Edward V. Sargent, PhD
This article presents currently suggested approaches to setting acceptance limits for cleaning agents, some of the difficulties with these approaches, emphasizing the need to move to a health-based approach as was suggested for APIs.
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Risk Assessment for Cross-Contamination in Solid Dosage Form Manufacturing Facilities
by Mock FMEA Special Interest Group (SIG), Containment COP, and ISPE Japan Affiliate
This article presents a risk evaluation method and case studies using Failure Mode and Effects Analysis (FMEA) introduced in ICH Q9 to establish cost-effective countermeasures for cross-contamination in solid dosage form manufacturing facilities.
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Facilities and Equipment

Master Planning the Legacy: Meeting Good Manufacturing Practices While Using Existing Pharmaceutical Manufacturing Facilities
by Eric Bohn, AIA
This article explores some of the challenges and opportunities that can be encountered when bringing legacy facilities into compliance with current good manufacturing practices.
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The Efficacy of Ozonated Water in Biofilm Control in USP Purified Water Circulation and Storage
by Erika Hanley-Onken and Nissan Cohen
This article presents a case study for the use of ozone to reduce the amount of biofilm contaminant in a pilot UPW production and delivery system designed to represent typical large 316L stainless steel systems in biopharmaceutical companies.
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Cleaning Validation: A Timely Solution for Improving Quality and Containing Cost
by Christopher Crone
This article presents an economic case for the use of on-line Total Organic Carbon (TOC) and conductivity analysis for validating automated CIP cycles with two separate case studies.
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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.
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Comparing Energy Consumption of RABS and Isolator Configurations
by Benjamin Hoffman, Katarzyna Frank, and Johannes Rauschnabel
This article presents a comparison of energy consumption of the ventilation and air conditioning system for a passive RABS, an active RABS, and an isolator system, including the different clean room requirements.
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The Application of Cogeneration for Pharmaceutical Facilities
by Joseph F. Masiello, PE CEM LEED AP
This article presents how the pharmaceutical industry has various unique characteristics, along with the various issues of concern for those in the industry contemplating the use of cogeneration.
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Product Development

A Practical Approach to Managing Knowledge – A Case Study of the Evolution of Knowledge Management (KM) at Merck
by Marty Lipa, Samantha Bruno, Michael Thien, ScD, and Robert Guenard, PhD
This case study presents the development of a knowledge management program, including the creation of a strategy, a suite of capabilities and model for sustaining the flow of knowledge, and establishing and maintaining the connection to improved business outcomes.
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Research and Development

Diaphragm Valve Development – Challenging Traditional Thinking
by Per-Åke Ohlsson
This article presents the shortcomings of the traditional diaphragm and demonstrates how changes in the new generation diaphragm valve can reduce maintenance costs, minimize the risk of contamination, reduce pressure drop, and provide better flow regulation.
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Also Inside

From the Editor

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ISPE Update
- Meet Your New Board
- ISPE Guide: Cleaning Process Development and Validation
- ISPE's Annual Conference on Barrier Isolation, RABS and Aseptic Processing Technology
- Pharma EXPO 2014


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Classified Advertising with Advertiser’s Index

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President's Message

The Strength of the Past has Enabled a Strong Today and an Even Stronger Future
by Nancy Berg, ISPE President/CEO
Berg discusses how the Society is positioned for growth in 2014 with the implementation of contemporary changes to some traditional approaches to product development and delivery, including the magazine, training, meetings, and conferences.
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Online Exclusives

Impact of Facility Layout on Developing and Validating Segregation Strategies in the Next Generation of Multi-product, Multi-phase Biopharmaceutical Manufacturing Facilities
by Mark F. Witcher, PhD
This article describes how the facility's layout impacts the process and product segregation strategies required to provide validated separation of products and processes throughout the manufacturing lifecycle.
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Design Features and Elements of Process Manifold Rooms
by Joseph R. Hettenbach, P.E.
This article describes the design features and elements that need to be considered for process manifold rooms.
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Rapid Increases of Key Regulators Precede the Increased Production of Pharmaceutically Valuable Compounds in Catharanthus roseus
by Noreen F. Rizvi, Sheba Goklany, Erin J. Cram, and Carolyn W.T. Lee-Parsons
This article was adapted from a research project that was presented at the ISPE International Student Poster Competition during the 2012 Annual Meeting. It was a finalist from the ISPE Boston Area Chapter.
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Global Regulatory News

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NOTE: Pharmaceutical Engineering article PDF documents are not to be posted on any Web site, blog site or page, or any other internet site without prior permission from ISPE. (Copyright © 2013 ISPE. All rights reserved.)