Waters Corp.

March 12, 2008
UPLC PAT System Integrates In-Process Analysis

Waters Corp. recently unveiled its new Waters PATROL UPLC Process Analyzer, a real-time Process Analytical Technology (PAT) System able to detect and quantify complex multiple component manufacturing samples and final product on the production floor.

Designed with the same enabling technology platform as Waters ACQUITY Ultra-Performance Liquid Chromatography (UPLC) System, PATROL UPLC moves existing liquid chromatography (LC) analysis from off-line Quality Control (QC) laboratories directly to the manufacturing stream resulting in significant improvements in production efficiency with real-time analysis, reducing both process cycle times and assuring product quality.

Waters is currently collaborating with several global pharmaceutical companies to quantify PATROL UPLC’s impact on the manufacturing process. A goal of real-time PAT is to produce more product with existing resources compared to a time-consuming, off-line QC process. Early analysis supports PATROL UPLC can enable process recovery increases during major manufacturing steps, virtually eliminating the need for any reprocessing. In general, increase in process recovery results in increase yield, which in turn translates into higher profits per batch.

Pharmaceutical, biopharmaceutical, petrochemical and food manufacturers are under increased internal and external pressure to evaluate their respective PAT Programs and techniques. Global regulatory initiatives, such as US Food and Drug Administration and European Medicines Agency Critical Path and PAT Initiatives, and manufacturing total quality programs, such as Six Sigma, are driving corporations to assess and implement novel PAT solutions.

Engineered to be simple to operate, rugged, and reliable, Waters PATROL UPLC provides highly reproducible QC laboratory capabilities such as automated purity and yield results, automated sign-off, and real-time release. This total system solution from Waters integrates and automates sample preparation capabilities, liquid chromatography instrumentation, a rich portfolio of column chemistries, process control communication interfaces, and a powerful chromatography data software application package.