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I joined ISPE with the hope of giving something back to an industry that has served me well over the last 15 years. After attending one conference, I knew I wanted to become an active Member in the organisation. I wanted to have a role in ISPE activities and events that benefited other industry Members. I found the transition from attendee to active Member relatively easy. Despite the fact that ISPE is a society made up of volunteers, passion and professionalism in which business was conducted was eye opening. In my 10 years as a Member, I have made many friends who have afforded me the benefit of their experience within OUR industry and have changed both my professional and social view point. ISPE is a wonderful organisation and I hope to be part of it for years to come.

Nigel Frost, Managing Director
Thermal Transfer, Ltd., United Kingdom

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Pharmaceutical Engineering Archives

January/February 2006
Volume 26, Number 1

Theme: Efficiency Improvements/PAT Solutions

 

 


Table of Contents

Articles

Process Analytical Technology (PAT) and Scalable Automation for Bioprocess Control and Monitoring – A Case Study
by Joydeep Ganguly and Gerrit Vogel
This case study provides a comprehensive look at Talecris Biotherapeutics’ approach to PAT and automation followed by examples of PAT deployed on a bioprocess. It introduces the concept of integrated and scalable automation, provides a comparison of automation concepts, and explains how the selected automation effectively supports initiatives like PAT.
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Pharmaceutical Facility Upgrades: The Containment Issues
by Martin Ryder
This article investigates the options for upgrading the containment performance of traditional pharmaceutical facilities using alternative (low cost) containment technologies.
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On-line Particle Counters Provide Detection and Control in Water for Injection (WFI) and Purified Water (PW) Systems
by Dr. Hans-Walter Motzkus and Joe Gecsey
This case study presents early contamination detection in an established WFI and PW system through the use of on-line particle counters.
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Interview with Emer Cooke, Head of Sector, Inspections, Veterinary Medicines and Inspections, EMEA
by Emer Cooke
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GAMP® Traceability for GxP Regulated Applications
by ISPE GAMP Forum
“Good traceability yields benefits” – guidance from the GAMP® Forum on achieving the correct level of traceability between requirements, design, and testing documents for regulated GxP applications.
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Country Profile: Thailand
by ISPE Thailand Affiliate
This section takes a look at the pharmaceutical industry in Thailand.
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A Hub Layout Concept for Oral Solid Dosage (OSD) Facilities
by M.P. Brocklebank, J. Lam, and P. Mehta
This article describes a new configuration for the layout of an OSD facility that closely integrates all of the facility contents plus optional R&D and administration areas. It presents a number of operating and GMP advantages, as well as potential capital and operational cost savings.
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