Tools for Streamlining the Manufacturing Process

René Schwarz of Rockwell Automation tells NGP why manufacturing execution systems are important for achieving operational excellence.

What are the chief advantages offered by MES?

René Schwarz. During previous years pharmaceutical and life sciences companies have faced a multitude of new challenges. Economic pressures, changing regulatory environment and portfolio pressures are demanding answers. Corporate initiatives like Lean manufacturing, Six-Sigma programs and real-time enterprise have been established to achieve operational excellence. Life Sciences companies often define operational excellence as the organizational capability to simultaneously meet regulatory and productivity requirements. Manufacturing execution systems (MES) can provide the tools and support methods to achieve operational excellence by providing visibility, tracking and control.

How can pharmaceutical and life sciences companies use manufacturing execution systems to streamline their manufacturing processes and achieve operational excellence?

RS. One of the major concerns of pharmaceutical and life sciences companies is the cost of compliance. MES can help by enforcing processes and specifications, as well as reduce the time required for batch report reviews and effort for investigations. It enables paperless production by eliminating paper batch records and other documents, such as equipment logbooks and standard operating procedures from the shop-floor.

Another issue is the time a company requires to launch a new product. Using MES can reduce scale-up times from product development through clinical to commercial manufacturing by employing standards like general and site recipes, as well as re-usable building blocks. In fact, these concepts can improve time-to-recipe in general and they help to establish and propagate best practices, which is key for continuous improvement.

Decisions about where a product is manufactured can be a critical cost factor. MES can provide value by simplifying the so-called tech-transfer, the transfer of a master recipe from one site to another.

What specific types of MES software tools are most useful in helping companies uphold production while maintaining the highest quality?

RS. For quite some years the application customers' realize the quickest return-on-investment has been weigh and dispense, which is unlikely to change in the near future. The weighing operator is guided through pre-defined workflows, which helps to reduce operator errors. Error-prone and time-consuming calculations are history. Furthermore, the software compiles a comprehensive weighing report that includes all information required by regulation. Material, equipment and personnel involved in the weighing process are tracked. The software enforces processes or specifications and manages deviations in a GxP-compliant manner. Weigh and dispense ensures compliance with regulations while it can significantly safe time and reduce cost.

However, what pharmaceutical and life sciences companies are striving for today is electronic batch recording (EBR). After achieving paperless production in the weighing booths, the next step is eliminating the paper still predominant in the manufacturing and packaging area. EBR presents electronic instructions on a screen to the operator and ensures that the batch documentation is always complete and correct. Manual data entry is limited to the absolute necessary and always checked against specifications and limits. If possible, process values are gathered directly from equipment and sensors to ensure its correctness. In any case an integrated exception management manages deviations from processes or specifications, which is key for review by exception. With that, significant reductions in batch review cycle time and effort for investigations related to deviations can be achieved.

In addition, manufacturing intelligence and performance management tools offer sophisticated reporting and data analysis capabilities as well as dashboards, and with that can help to turn the data that has been gathered during production into valuable information – information that is vital to establish further processes improvements.

How do you expect the use of MES to develop within the pharmaceutical industry in the future?

RS. MES has been primarily adopted by larger pharmaceutical companies and for their larger sites. However, best practices that have been established throughout past years, which combined with technology innovation will further reduce cost of deployment as well as total cost of ownership (TCO) for MES. With that the entry point becomes low enough to make MES reality for smaller pharmaceutical companies respective smaller sites.

Furthermore the pharmaceutical industry will consequently pursue trends like process analytical technology (PAT) and quality by design (QbD). Best practices and standards have been developed by industry associations, suppliers and customer themselves and MES will follow with supporting functionality and interfaces.

René Schwarz is the Product Manager of FactoryTalk Pharma Suite. René has been working for more than 20 years in various roles developing software products and solutions tailored to the needs of the life sciences industry. His domain knowledge covers product and process development throughout clinical to commercial primary and secondary manufacturing.