Abstract
In an environment where cost, timeliness, and quality drives the business, it is essential to look for answers in technology where these challenges can be met. In the Novartis Pharmaceutical Quality Assurance Department, automation and robotics have become just the tools to meet these challenges. Although automation is a relatively new concept in our department, we have fully embraced it within just a few years. As our company went through a merger, there was a significant reduction in the workforce within the Quality Assurance Department through voluntary and involuntary separations. However the workload remained constant or in some cases actually increased. So even with reduction in laboratory personnel, we were challenged internally and from the headquarters in Basle to improve productivity while maintaining integrity in quality testing. Benchmark studies indicated the Suffern site to be the choice manufacturing site above other facilities. This is attributed to the Suffern facility employees' commitment to reduce cycle time, improve efficiency, and maintain high level of regulatory compliance. One of the stronger contributing factors was automation technology in the laboratoriess, and this technology will continue to help the site's status in the future. The Automation Group was originally formed about 2 years ago to meet the demands of high quality assurance testing throughput needs and to bring our testing group up to standard with the industry. Automation began with only two people in the group and now we have three people who are the next generation automation scientists. Even with such a small staff,we have made great strides in laboratory automation as we have worked extensively with each piece of equipment brought in. The implementation process of each project was often difficult because the second generation automation group came from the laboratory and without much automation experience. However, with the involvement from the users at ‘get-go’, we were able to successfully bring in many automation technologies. Our first experience with automation was SFA/SDAS, and then Zymark TPWII followed by Zymark Multi-dose. The future of product testing lies in automation, and we shall continue to explore the possibilities of improving the testing methodologies so that the chemists will be less burdened with repetitive and mundane daily tasks and be more focused on bringing quality into our products.