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PHILADELPHIA, Penn., (November 27, 2007) – Thermo Fisher
Scientific Inc., the world leader in serving science, announces that it has been
selected by APP Pharmaceuticals Inc. (formerly known as Abraxis Pharmaceutical
Products) for a three site multi-phase rollout of Thermo Scientific Darwin
LIMS™. Darwin, a purpose-built laboratory information management system (LIMS)
for pharmaceutical manufacturing R&D and QA/QC, will be deployed in all
three of APP's manufacturing facilities located in New York, Illinois and Puerto
Rico.
APP Pharmaceuticals’ products have helped millions of people in
the United States and Canada fight critical illnesses by providing a broad
portfolio of multi-source and branded injectable pharmaceutical products,
including difficult to manufacture and urgently needed medical products. The
project is intended to harmonize processes, automate operations and consolidate
data management in a single LIMS across all three sites.
The multi-phase project will initially involve the deployment
of Darwin's inherent Environmental Monitoring functionality enabling facilities
to move from manual systems onto an automated system for microbiological samples
from the sterile manufacturing environment.
The second phase of the project will feature an integrated LIMS
and Chromatography Data System (CDS) implementation followed by the third phase
of the LIMS rollout including SAP interfaces across all sites.
Hector Jimenez, Senior Director of Quality Operations at
APP, commented: "We selected Darwin LIMS because it offers purpose-built
functionality for pharmaceutical manufacturing - the solution is extremely easy
to configure and use for our environmental and our chemistry laboratories. In
addition, we are confident that Darwin LIMS will provide efficiency improvements
in the tracking of samples and in capabilities of trending data as well as
compliance."
Thermo Scientific Darwin LIMS is a purpose-built LIMS for
pharmaceutical manufacturing R&D and QA/QC laboratories. Since it contains
an Environmental Monitoring module as standard, implementation and validation
time and costs are greatly reduced versus generic LIMS. Environmental monitoring
is essential for product monitoring and compliance. Thermo Scientific Atlas CDS
is a GLP and 21 CFR Part 11 compliant enterprise CDS. Atlas CDS provides
comprehensive multiple vendor instrument control. With ease of deployment and
validation across laboratories and sites, laboratory efficiency is gained by
automating the laboratory.
For more information about Thermo Scientific Darwin LIMS,
please call +1 866-463-6522, e-mail marketing.informatics@thermofisher.com or visit
www.thermo.com/informatics
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Thermo Scientific is part of Thermo Fisher Scientific, the
world leader in serving science.
About Thermo Fisher Scientific
Thermo Fisher Scientific Inc. (NYSE: TMO) is the world leader in serving
science, enabling our customers to make the world healthier, cleaner and safer.
With an annual revenue rate of more than $9 billion, we employ 30,000 people and
serve over 350,000 customers within pharmaceutical and biotech companies,
hospitals and clinical diagnostic labs, universities, research institutions and
government agencies, as well as environmental and industrial process control
settings. Serving customers through two premier brands, Thermo Scientific and
Fisher Scientific, we help solve analytical challenges from routine testing to
complex research and discovery. Thermo Scientific offers customers a complete
range of high-end analytical instruments as well as laboratory equipment,
software, services, consumables and reagents to enable integrated laboratory
workflow solutions. Fisher Scientific provides a complete portfolio of
laboratory equipment, chemicals, supplies and services used in healthcare,
scientific research, safety and education. Together, we offer the most
convenient purchasing options to customers and continuously advance our
technologies to accelerate the pace of scientific discovery, enhance value for
customers and fuel growth for shareholders and employees alike. Visit
www.thermofisher.com.
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