Waters Patrol keeps a close eye on PAT

The new 'real time' system is able to carry out in process analysis of multiple component manufacturing samples and final product samples directly on the production floor without the manufacturing process having to wait for off-line results from the QC department in order to proceed. For the first time it makes liquid chromatography a realistic option for PAT, according to the company. The liquid chromatography system uses the same technology platform as the Acquity UPLC system first introduced by Waters in 2004. It uses a dual wavelength tuneable UV/visible detector with Empower 2 chromatography data software, automatic sample preparation and has a wide choice of column chemistries suitable for different applications. The Waters concept of this system envisages it being introduced to monitor several critical stages in a manufacturing process in industries such as pharmaceuticals, food, biopharmaceuticals and the petrochemical industries (particularly at purification and polishing stages). The Patrol system is currently being evaluated by several large pharmaceutical companies for introduction into their manufacturing processes. The claimed advantages will be to save time (reduce process cycle times), increase safety as more analyses can be carried out at each critical stage and to increase manufacturing output. Out-of-specification problems can also be detected at an earlier stage and process recovery implemented more quickly if required. The system will know what compounds to look for at any particular stage and will provide reports rapidly, accurately and more often than would normally be expected. Craig Dobbs, senior manager, pharmaceutical business operations, at Waters, said: "Waters Patrol UPLC creates a foundation of confidence by enabling quantifiable, real-time, in-process analysis directly on the manufacturing floor.​" PAT techniques are becoming more and more important to large industries and the Patrol system can provide a QC laboratory at each stage. The system, which gives highly reproducible QC results, allows capabilities such as automated purity and yield results, automated sign off, final release testing and real time release (detection of impurities to 0.01 per cent). In addition the system can be fitted with Connections INSIGHT, which is an intelligent service delivery system that can provide remote servicing, diagnostics and alerts with continuous system monitoring. Dobbs added: "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." ​