Multi-Site Pharmaceutical Manufacturing Operation Standardizes on Thermo Scientific Solution
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(TM). 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 firstname.lastname@example.org or visit http://www.thermo.com/informatics
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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