May/June 2006
Volume 26, Number 3

Theme: Project Delivery and Construction Management 

Table of Contents

Articles

Primer of Design and Construction Delivery Methods for Today’s Modern Pharmaceutical and Biotech Facilities
by Brian Sirbovan, Dave DiProspero, and Brian Larson
This article presents four common project delivery methods and discusses the significant features of each approach.
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Achieving Faster Project Delivery – More Haste, Less Speed
by Gordon R. Lawrence
This article discusses how implementing proven Best Practices can help get products to market quickly and more competitively.
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Capital Costs for Biopharmaceutical Process Retrofit Projects
by Stephen R. Higham
This article presents cost data and analysis from several recent large process retrofit projects inside an active manufacturing plant. It also provides cost data for several types of process equipment and digital fieldbus DCS systems. It compares retrofit costs with greenfield construction costs.
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Efficient Qualification: A Holistic Approach to Effective Project Execution
by Anna Kälvemark and Gordon Leichter
This article addresses an innovative development in project delivery that utilizes a risk-based integrated qualification approach based upon the effectiveness of off-site construction.
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Interview with Ron Branning, Vice President, Commercial Quality, Genentech
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2006 Facility of the Year Winner: A Look at Baxter BioPharma Solutions Cutting-Edge Facility
by Rochelle Runas
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Country Profile: Turkey
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Site Master Planning
by Richard Larkin
This article presents a methodology for the delivery of a Site Master Plan (SMP) for a pharmaceutical facility. It describes a three step execution and presents a list of issues that appear regularly during the development phase.
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A New Approach to Vapor Hydrogen Peroxide Decontamination of Isolators and Cleanrooms
by Kunihiro Imai, Soma Watanabe, Yasusuke Oshima, Mamoru Kokubo, and Jim Akers
This article presents research into factors relating to the efficiency and efficacy of vapor phase hydrogen peroxide decontamination. The studies presented demonstrate that initial dehumidification of the target can adversely affect efficacy and that continuous injection of vapor hydrogen peroxide is not required.
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PCC Supplement
Developing and Implementing a Certification Program to Drive Change in the Pharmaceutical Industry
by Jerry Roth, PE, Dr. Russ Somma, Dr. Sandra Greenberg, and Alexander P. Demos
This article describes the credential development process utilized by the ISPE-PCC and the results obtained from the CPIP TM international practice analysis.
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