Volume 24, Number 5
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.
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.
by Paul Leonard, Lou Angelus
This article presents drug discovery research trends and identifies the impact on laboratory facility design, construction, and operation.
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.
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.
by Werner Seiferlein
This article compares the benefits and potential difficulties involved in either renovating an existing facility or building a new facility.
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.
by Colin Andrews
This article explores the need for a more strategic approach to outsourcing decisions in clinical materials management.
by Lee Anderson, Devar Burbage
This article describes a methodology and supporting tools focused on quantifying the cost-savings benefits of new system implementation.
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.
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.
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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