Leading Oral Health Product Manufacturer, Ultradent, Takes Steps to the Future with Critical Manufacturing MES

Ultradent’s manufacturing facilities are highly vertically-integrated and incorporate many interdependent manufacturing capabilities, such as weighing and dispensing, mixing, injection molding, primary package filling, kitting, laboratory, CNC machining, assembly, printing, and other specialized operations. There are many manual operations, as well as automated equipment and robotics throughout the operation to ensure efficiency and tight tolerances. Ultradent also has an ongoing robust pipeline of new, innovative products and product improvements at all times.

Ultradent adheres to good manufacturing practices, strict medical device practices, and pharmaceutical documentation standards. Each manufactured lot requires a unique batch or device history record to demonstrate that each product is manufactured in accordance with its design specification, or Device Master Record (DMR).

The new MES will provide fully electronic Batch Records (eBR) and electronic Device History Records (eDHR), including critical process parameters and critical quality attributes to streamline production while ensuring the highest product quality. While the MES eliminates paper in manufacturing, it will also enable shop floor to top floor visibility and provide actionable insights to manufacturing processes in order to support continuous process improvement.

The Critical Manufacturing MES is a state-of-the-art, highly-configurable and modular MES/MOM platform, designed to enable the benefits of a smart factory, based on the Industry 4.0 manufacturing model. The Critical Manufacturing MES is well-suited for medical device manufacturers, and with its special weigh and dispense capabilities, it is well-suited for both batch chemical formulations as well as discrete manufacturing. The MES will also integrate into existing PLM, ERP, LIMS, and control systems using very little code.

Chuck Anger, VP of Operations at Ultradent said: “The Critical Manufacturing MES will augment our vertically-integrated manufacturing operations at Ultradent. We want a path to the benefits that smart manufacturing offers. The new MES will enable us to increase efficiency, make adherence to quality procedures more robust, and reduce costly paperwork and manual interventions. We will be able to respond more quickly to customer demands and changing order requirements.”

Ultimately, the Critical Manufacturing MES will enable a smooth transition to Industry 4.0, allowing traditional production methods to run alongside smart, dynamic ones. By using real-time data and advanced analytics, continuous process improvements can be implemented, and with real-time analysis of process performance, quality can be built into all steps of the production line.

Mohamed Benkirane, VP Medical Device Practice for Critical Manufacturing said, “The use of electronic records and real-time data will help Ultradent both enhance quality and reduce costs. In addition, our advanced analysis and search tools will enable them to improve manufacturing processes and consistently learn from electronic records. Everyone will benefit – Ultradent, their customers, and their suppliers.”

The Critical Manufacturing MES functions will include recipe and specification management, weighing and dispensing, and manufacturing data acquisition, which will be fed into the eBR for batch chemistries and eDHR for discrete products. The system will give Ultradent a clear view of all shop floor processes with supervisory dashboards and real-time factory floor status.

Chuck Anger concluded, “After a long and well-engineered due diligence process, we selected Critical Manufacturing MES because of its modularity, inherent flexibility to support the many and varied processes we have, and its clear path to an Industry 4.0 production model. We also believe that working directly with the Critical Manufacturing team in Portugal to be an advantage during implementation and for years to come. Our company has grown year on year over the past four decades, but this investment is the start of a particularly exciting time for our business and one, I believe, that will be the cornerstone of our future innovation and growth.”