Volume 24, Number 5

Table of Contents

Articles

Measuring Process Temperature in Small Diameter Lines

by Greg Thorp, 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.

Biotech CIP Cycle Development

by Timothy Howard, 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.

Planning and Operational Aspects of Robotics Laboratories

by Paul Leonard, Lou Angelus
This article presents drug discovery research trends and identifies the impact on laboratory facility design, construction, and operation.

Design Criteria and Evaluation of Pharmaceutical Containment Systems - Evaluation for Closed Isolation Systems

by Osamu Suzuki, Morihiko Takeda, Koji Tanaka, Mamoru Numata
This article describes the design criteria and a containment evaluation for bulk manufacturing facilities with closed isolation systems.

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.

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.

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.

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.

Estimating ROI for Automated Clinical Materials Management Systems

by Lee Anderson, Devar Burbage
This article describes a methodology and supporting tools focused on quantifying the cost-savings benefits of new system implementation.

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.

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.

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.

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