September/October 2004
Volume 24, Number 5

Theme: Emerging Technologies

Table of Contents

Articles

Measuring Process Temperature in Small Diameter Lines
by Greg Thorp, PE and John Zwak
This article presents the advantages and disadvantages of various temperature measurement methods and highlights the use of a Platinum Resistance Thermometer (PRT) to measure the process.
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Biotech CIP Cycle Development by Timothy Howard and Matt Wiencek This article demonstrates how the principles of ISPE's C&Q Baseline® Guide can be applied to a cycle development program at a modern biotech manufacturing facility. Download Article...

Planning and Operational Aspects of Robotics Laboratories by Paul Leonard and Lou Angelus This article presents drug discovery research trends and identifies the impact on laboratory facility design, construction, and operation. Download Article...

Design Criteria and Evaluation of Pharmaceutical Containment Systems - Evaluation for Closed Isolation Systems by Osamu Suzuki, PhD, Morihiko Takeda, Koji Tanaka, and Mamoru Numata This article describes the design criteria and a containment evaluation for bulk manufacturing facilities with closed isolation systems. Download Article...

An Introduction to Clinical IVR Systems by Anthony Chow This article presents ways in which Clinical Interactive Voice Response (IVR) Systems are used to enhance trial communications, request trial supplies for investigational sites, provide instant updates for trial sponsors, and save money in the process. Download Article...

Renovation Versus New Build by Werner Seiferlein This article compares the benefits and potential difficulties involved in either renovating an existing facility or building a new facility. Download Article...

Isolator Campaigning - An Industry Survey and Discussion of Operational Practices by Douglas Stockdale This article discusses the recent trend of Campaigning sterile drug batches in conjunction with the installation of isolator technology for aseptic fill/finish operations. The article was based on a presentation that was held at the 11th Annual Barrier Isolation Technology Forum in Arlington, VA, June 2002. Download Article...

Country Profile: Czech Republic and Slovakia by ISPE Czech Republic and Slovakia Affiliate This section takes a look at the pharmaceutical industry in the Czech Republic and Slovakia. Download Article...

Supplement Articles   Strategic Value of Clinical Supplies by Colin Andrews This article explores the need for a more strategic approach to outsourcing decisions in clinical materials management. Download Article... Estimating ROI for Automated Clinical Materials Management Systems by Lee Anderson and Devar Burbage This article describes a methodology and supporting tools focused on quantifying the cost-savings benefits of new system implementation. Download Article... Annex 13: An Update by David Barnes This article provides a current overview of the European Commission’s (EC) Good Manufacturing Practices (GMPs) “Annex 13.” Annex 13 is used for the manufacture of investigational medicinal products. This overview will include a brief history of the Annex, the relationship the Annex has with the Clinical Trials Directive, and a comparison of the 2003 version with the current (2002) version. Download Article... External Sourcing of Clinical Trial Materials - Part 2: Impact of Electronic Automation on the Sourcing Model for Clinical Supplies Preparation by Charles F. Carney This article identifies and discusses some of the regulatory and control system concerns for the utilization of electronic systems between sponsor and contractor companies for the preparation, control, and distribution of clinical trial materials, and provides some ideas for the proactive development of the relationship between sponsor and vendor that can minimize any adverse impact and maximize the strengths and value of the relationship. Download Article... External Sourcing of Clinical Trial Materials - Part 1: Process and Points to Consider by Charles F. Carney This article describes an objective process and points to consider in formulating the plan and decision to outsource any of the clinical trial supplies production, distribution, and reconciliation steps. Download Article...