Downloads, White Papers

Accelerating the Commissioning Process in Life Sciences: How Process History Data Can Be Used to Streamline Commissioning
by Mark Cubine and Ed Sullivan

Request a copy of this paper - please click here.

Paper Overview
Everyone in Life Science manufacturing understands that there is tremendous value in finding ways to accelerate the commissioning process. A great deal of time and money is at stake. Commissioning is unavoidable because governmental regulations require that Life Science manufacturing companies qualify the validity of the end product manufactured in the plant. In order to do this, companies must establish and document how the production process for each product will produce the desired result with perfect predictability and consistency. Creating and refining a production process in this way is the work of commissioning.

In this paper, EnteGreat authors Mark Cubine and Ed Sullivan discuss an approach to accelerating commissioning that several Life Science manufacturers have embraced. This approach is based on using process data historians, a common software application that is an element in many automation architectures, to facilitate a process that accelerates commissioning and can reduce the time and cost associated with this necessary task.

Paper Outline

• Introduction
• The Manufacturing Challenges that Come with the Commissioning Process
• How Process History Data Can Be Used to Streamline Commissioning
• Key Steps Towards a Streamlined Commissioning Process
• Conclusion

About the Authors
Mark Cubine has over 24 years of experience in manufacturing, including work within the Food & Beverage, Consumer Products, Pulp & Paper, Steel, Specialty Chemicals/Fibers/Films, Printing, Pharmaceuticals, Biotech, Automotive, and Electronics industries. He has gained experience across the entire range of technologies employed in manufacturing, from control systems to ERP. Mark has worked for Honeywell, Hewlett-Packard, Measurex, Rust International, and Raytheon.

Ed Sullivan has over 19 years experience designing, developing, and implementing manufacturing and supply chain system solutions in both North America and Europe. This experience includes roles ranging from consulting to system design and implementation across a variety of industries including Life Sciences, Food, Beverage, Chemical, and Metals. He has a BS IE and MBA from the University of Pittsburgh and an MS IE from Arizona State University. He is a registered professional engineer with membership in both ISPE as well as APICS, with both CPIM and CIRM certifications.

Request a copy of this paper - please click here.