October 2008 www.thecolumn.eu.com The Column Q&A Getting Real Craig Dobbs from pharmaceutical business operations at Waters reveals what the company can offer scientists involved in implementing process analytical technology (PAT) and why the company has launched a chromatography system dedicated to this market that offers real-time monitoring. Why is PAT important at the moment? Manufacturers across all industries have become highly focused on maintaining consistent quality while increasing operational efficiencies. Most have implemented Six Sigma or Lean Manufacturing Programmes to begin to address these needs. PAT is one component of a total quality system that enables manufacturers to achieve operational efficiencies and increase revenues and profitability. For the pharmaceutical industry in particular, the FDA has created a number of initiatives around driving the consistent quality of the medicines we all take. Quality and consistency are two key parameters that cannot be “tested” into a product — meaning that final quality control (QC) can only tell you if you’ve achieved your product specifications but can’t help you consistently meet or exceed those specifications. PAT is designed to enable manufacturers to consistently meet or exceed their product specifications by having the ability to dynamically adjust the manufacturing process based on real-time feedback information. software. It is critical for a Manufacturer’s Quality, PAT or Six Sigma Team to work very closely with their vendors and consultants to ensure the system solutions chosen meet both their tactical and strategic objectives. It is critical that the solution chosen is thoughtfully designed for a specific function and purposefully built for that task. Why has Waters designed an instrument aimed specifically for PAT applications and what benefits does it offer scientists involved in implementing PAT? Because most in-process quality control work is done in off-line QC labs, there exists a significant delay between sampling from the production line and receiving the results. A MIT study showed that manufacturers often spend more time analysing the product than manufacturing it.1 In one case study, five of the six manufacturing processes profiled required more time for analysis than the actual manufacturing time. This new PATROL UPLC system was designed to enable these manufacturers to bring real-time QC analysis to the production floor, virtually eliminating analysis delays. What do manufacturers evaluating PAT need to consider? PAT is just one component of an overall quality system — it is not as easy as simply plugging in a sensor or adding new Contact: Craig Dobbs E-mail: craig_dobbs@waters.com What benefits does this technology offer specifically? The new system combines the performance benefits of liquid chromatography (LC) analysis with real-time result reporting. A number of technologies exist today for real-time PAT in-process 29
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Table of Contents for the Digital Edition of The Column - October 2008