Multi-Site Pharmaceutical Manufacturing Operation Standardizes on It's LIMS Solution

Thermo Fisher Scientific Inc., 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.”