January/February 2014
Volume 34, Number 1

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 © 2014 ISPE. All rights reserved.)


 

Facilities and Equipment

Application of Single-Use Equipment for Buffer Storage and Distribution in Medium Size mAb Production Facility
by Wilfried Kappel, Bhimasen Vadavi, Sanjay Lodha, and Daniel Karrer, PhD
This article presents a hybrid system approach in which stainless steel equipment and single-use equipment have been combined in the best possible manner for buffer preparation and buffer storage systems at a 2,000 L mammalian cell culture CMO production facility.
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Evaluation of Controlled Manufacturing Environments following an Air Handling Unit Shutdown
by Catherine E. Anderson and Brian J. Lloyd, PhD
This article provides a methodology to evaluate the environmental impact of an air handling unit shutdown in a GMP manufacturing environment.
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Electron Beam: An Emerging Practical Technology for Sterilization of Pharmaceutical Products in an Innovation-Driven Industry
by Jorge A. Sugranes and Anne F. Booth
This article presents an overview of the potential use of electron beam (e-beam) ionizing radiation as a versatile and innovative technology for sterilization in the pharmaceuticals manufacturing industry.
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Information Systems

Harmonizing USP <1058> and GAMP for Analytical Instrument Qualification
by Lorrie Vuolo-Schuessler, Mark E. Newton, Paul Smith, Christopher Burgess, and R.D. McDowall
This article presents a framework for harmonization of the approaches presented by the GAMP GPG on Compliant Laboratory Computerized Systems with the revised USP <1058>.
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Cloud Computing in a GxP Environment: The Promise, the Reality and the Path to Clarity
by the GAMP Cloud Computing Special Interest Group (SIG)
This article presents the current issues facing adoption of cloud computing, paradigm shifted needed and a strategy for establishing guidance within the pharmaceutical industry.
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Product Development

The Blinding of Materials in Clinical Trials: Essential Processes for Ensuring the Integrity of Clinical Study Data
by Sandra Cook, Steven Yoder, Christina Owings, Barbara Campbell, and Charles Gentile
This article explores concepts for maintaining the blind throughout a trial and at various nodes in the clinical trial material supply chain.
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Regulatory Compliance

A Selected Comparison of 21 CFR Part 111 and USP General Chapter <2750> as Templates for Good Manufacturing Practices for Dietary Supplements
by Edward G. Malawer, PhD
This article presents a comparison of corresponding sections of 21 CFR Part 111 and USP <2750> using five dietary supplement GMP compliance issues each requiring some interpretation of the language provided by these documents.
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Also Inside

From the PEC Chair
The Chair of the Pharmaceutical Engineering Committee presents his vision for a new editorial strategy that will introduce contemporary topics and stimulate reader interest, while maintaining the scientific integrity and quality content that readers have come to expect.
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ISPE Update
ISPE International Honor Awards 2013; ISPE’s Facility of the Year Program Celebrates its 10th Anniversary; ISPE Launches New Expanded E-Learning Courses; ISPE 2014 Drug Shortage Initiative; ISPE Contributes to FDA Strategic Plan; FDA Strategic Plan Summary; ISPE 2013 Annual Meeting Highlights; Zimmer Named ISPE Vice President of European Operations; ISPE Biopharmaceutical Manufacturing Facilities Guide
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Classified Advertising with Advertiser’s Index

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President's Message

ISPE Stretches its Reach in new Opportunities while Building on its Traditions
by Nancy Berg, ISPE President/CEO
Berg shares new opportunities to lead, build and enhance valuable Member benefits and increase the Society visibility among Members, companies and executives.
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Online Exclusives

Challenges in New Quality Concepts
by Nilesh Mohachkar, Xiaoyan Jia, and Yiling Ma
This article presents challenges in the implementation of ICH Q8 Pharmaceutical Development, ICH Q9 Quality Risk Management, ICH Q10 Pharmaceutical Quality Systems, ICH Q11 Development and Manufacture of Drug Substance, and product lifecycle management in line with ISPE’s PQLI Guide Series.
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Multi-Purpose Plants for API Production
by Kazuo Tozaki, PE
This article summarizes the different types of multi-purpose plants and clarifies the issues involved in their design.
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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 © 2014 ISPE. All rights reserved.)