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Pharmaceutical Processing News
News Release from: Isogen | Subject: Isogen
Edited by the Processingtalk Editorial
Team on 28 March 2008
AES modular cleanrooms chosen for Isogen
facility
The new Isogen sterile contract filling facility in New Castle County, Delaware will use AES Clean Technology to design and build their new cleanroom macro environment
Isogen has chosen AES Clean Technology to design and build their new cleanroom macro environment in New Castle County, Delaware, announced Cliff Satterfield, President of AES AES Clean Technology is the leader in design, construction and manufacture of cleanroom facilities for life science and technology companies, specialising in modular project execution
This article was originally published on Processingtalk on 16 Nov 2004 at 8.00am (UK)
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"We are very excited to be working with Isogen," said Cliff Satterfield, AES President: "This facility will demonstrate how to 'do it right' and will provide vital clinical manufacturing capacity in the US to support the pharmaceutical industry with the sterile filling of potent and non-potent compounds from development, through clinical, launch and commercial production.
What makes this project especially significant is the approach to isolation and containment within micro and macro environment.
The concept of an isolator, within a gas-sterilisable modular cleanroom makes this contract manufacturing facility ideal for smaller volume clinical or early stage commercial fills where a dedicated filling facility is financially untenable.
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There is increasing concern among regulators and healthcare organizations with regard to the risk of cross contamination where potent compounds, live viruses, and cytotoxics are being filled.
This concern is well documented especially in multi-product facilities, and CMOs are often used for such clinical fills".
Isogen chose modular cleanroom construction rather than traditional "stick built" construction to maximize value for the delivery of functional, adaptable cleanroom systems with the benefits of predictable cost, schedule, and quality.
"It was critical that the construction be timely and economical," explained Austin McDonald, Isogen COO: "AES was the obvious partner because their modular cleanroom strategy is designed to be integrated directly into a building shell.
This 'plug and play' approach allowed us to design a building shell and drop in the cleanroom modules saving over months and significant cost versus traditional 'stick built' construction".
Isogen CEO Les Edwards concluded, "In addition to construction efficiency, performance is critical; the isolator cleanrooms must be both an effective barrier and be demonstrably cleanable to enable multi-product use.
The integrated design of the AES modules with integrated HVAC and utility chases combined with AES design and installation expertise ensures our facility will meet the highest standards of containment".
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