Waters' real-time technology increases production efficiency

Waters Corporation recently unveiled its new Waters' Patrol Uplc process analyser, which is a real-time process analytical technology (PAT) system that will be able to detect and quantify complex multiple components, manufacturing samples and final product on the production floor. It is 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 the 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 Patrol Uplc creates a foundation of confidence by enabling quantifiable, real-time, in-process analysis directly on the manufacturing floor," said Craig Dobbs, Senior Manager Pharmaceutical Business Operations, Waters Division. "Liquid chromatography is the 'gold standard' for analytical testing because of its unmatched selectivity, sensitivity, and dynamic range, combined with its unique ability to resolve and quantify related and unrelated compounds. However, until today, LC has not been a viable PAT technique due to unacceptably long analysis times needed for sufficient resolution, lack of efficient automation, and the need for often-complex data reduction and analysis. Waters Patrol Uplc analytical power and speed redefines the PAT equation," added Dobbs.

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 products with existing resources compared to a time-consuming, off-line QC process. Early analysis supports Patrol Uplc, as it can enable process recovery 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.

Thoughtfully 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 the industry's most popular and powerful chromatography data software application package. Additionally, Patrol Uplc is designed to maximise the ease and speed of routine service, including fitting the system with Waters connections insight for real-time service requirements or alerts.