Product category:
Plant Design and Construction
News Release from: Emerson Process Management | Subject: PlantWeb at Genzyme
Edited by the Processingtalk Editorial
Team on 27 April 2004
Reducing the start-up time of bio-pharma
plants
The technology of PlantWeb has been applied to dramatically reduce the time and cost of validating the automation software running new and updated Genzyme manufacturing plants
Emerson Process Management has announced the successful use of its PlantWeb digital plant architecture by Genzyme Corporation of Cambridge, USA The technology of PlantWeb has been applied to dramatically reduce the time and cost of validating the automation software running the new and updated Genzyme manufacturing plants
This article was originally published on Processingtalk on 15 Oct 2008 at 8.00am (UK)
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Genzyme is one of the world's largest global biotechnology companies.
It is a leader in developing and manufacturing therapies that improve the quality of life of patients around the world who suffer from rare genetic diseases.
The joint Emerson-Genzyme effort has grown from an initial project that delivered re-control of a microfiltration skid in 2000, to a strategic approach for the automation of all aspects of new Genzyme manufacturing plants.
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The software development and validation techniques employed, as well as the technology that made it possible, will help shave 6-12 months off new plant start-up dates compared to using conventional validation methods.
"Three enormous benefits result," reports Phillip Maderia, Genzyme Associate Director of Automation Engineering.
"First, the Genzyme ROI will begin earlier, mitigating some of the risk in building new plants.
Second, the cost of validating the automation software will be substantially reduced.
Third, and most exciting, for new rProtein drugs in the FDA approvals process, Genzyme will get them to market earlier, and patients will have them sooner".
"Key to achieving the time savings," according to Maderia, "is the ability that Genzyme now has to validate the software before automation equipment is installed, as opposed to after its installation.
Pre-installation validation requires a combination of technology and method to assure that the application software development, testing, and documentation is complete and unassailable.
Neither technology nor method alone can bring success.
And, it's a strategic combination that cannot be created overnight".
It has taken Genzyme three years to create the new procedures and validate modules for 95% of all control elements typically used in a biotech plant.
The effort began by validating standalone equipment such as skids.
It then graduated to partial production lines and finally to entire lines and plants.
Each project required that additional modules be developed.
Obviously, the up-front effort was high.
But today, Genzyme is reaping solid returns by leveraging the validated modules, calling each one over-and-over to quickly and efficiently automate equipment and production lines before installation.
"Genzyme has demonstrated foresight and leadership in tackling some of the greatest challenges facing the Life Sciences industry, and we are honoured to be part of this success," commented John Gardner, Process Systems Vice President, Emerson Process Management.
"The team of Genzyme technologists and the pharmaceutical industry centre experts in Emerson have applied the technology within DeltaV software and PlantWeb architecture to deliver validated, modular solutions that Genzyme is able to apply across multiple projects - that's exciting for Emerson as well as Genzyme and its customers".
"Our ability to apply these validated modules over and over enables cost efficiencies and earlier start-up dates," Maderia concluded.
"Unlike the past, validation is no longer the antithesis of automation. Request a free brochure from Emerson Process Management ...
This new strategic software approach helps us keep automation off the critical path of the project.".
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