Foster-Miller developed a first-of-its-kind laboratory automation system for one of the world's largest pharmaceutical companies to support its drug stability and release testing and drug development. In order to receive Food and Drug Administration (FDA) approval, every new drug developed for use in the U.S. must be tested to determine its safety, and then repeatedly tested over time to validate its effectiveness and stability. Scientists and chemists normally conduct these tests using manually intensive methods to prepare a large battery of drug samples for analysis with sophisticated instruments. Stability and release testing generates significant volumes of data that must be collected, evaluated, approved and stored, in compliance with the FDA's 21CFR Part 11 requirements.The laboratory automation system Foster-Miller developed consists of a series of work cells that continuously process incoming samples that can be in the form of a powder, tablet, capsule or liquid. The incoming samples are automatically divided, and then transported from work cell to work cell by an autonomous robot system that simultaneously delivers and retrieves multiple samples. The automated work cells not only prepare the incoming samples without a chemist's involvement, they also perform the various analytical tests called for by the stability/release protocol. All of the sample preparation processes (measuring, mixing, extracting, filtering, diluting, etc.), plus analysis testing and data collection are performed in accordance with specified and validated procedures called "e-methods." The system uses a state-of-the-art software system that identifies and tracks all samples and is GXP/21 CFR Part 11 compliant. The laboratory automation system allows pharmaceutical companies to shave time off the stability/release drug testing cycle, thereby speeding drugs to market. In addition, the amount of manual labor and personnel exposure to drugs and solvents is greatly minimized. This innovative solution also allows record keeping and approval processes to be moved from a paper-based environment to an electronic environment.
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