Finesse Solutions, Inc., Santa Clara, CA, a manufacturer of measurement and control solutions for life sciences process applications, announced the launch of SmartFactory, which is a uniquely configurable design architecture for single-use facilities. The Finesse SmartFactory is based on Finesse SmartParts, the measurement and actuation building blocks which comprise SmartSystem process automation solutions. Finesse now proudly introduces SmartMES, a complete operations-management solution for the Finesse SmartFactory.
SmartFactory has been designed with an open architecture that leverages Finesse SmartSystem universal controllers. This enables the process flow to be designed with user-preferred equipment in a modular and scalable manner, while fully maintaining quality and regulatory compliance in the electronic batch records. SmartFactory implementation is completely flexible, so that the user can focus on the level of automation required for each unit operation and the consistency of single-use film materials between upstream and downstream, without compromising the project budget or timeline. SmartFactory is based on the DeltaV© control and batch platforms from Emerson Process Management.
SmartMES optimizes plant-wide resource utilization, integrates manufacturing batch information, and facilitates training and validation record management. SmartMES is a COTS Level 3 solution based on the seamless integration of Finesse upstream (TruBio©) and downstream (TruPurTM, / TruChromTM) GAMP5 process control software.
"As the challenges in biologics and vaccine manufacturing increase with fewer blockbuster drugs, emerging markets, patent expiration, shorter time-to-market, reimbursement price pressure, and increased regulatory complexity, companies are turning to multi-product single-use facilities. These facilities can provide higher yield production with fewer employees at a greatly reduced capital expenditure. They also, however, require far greater operations management system flexibility," stated Dr. Barbara Paldus, CEO of Finesse Solutions. "Our SmartFactory platform is highly flexible and configurable so that it can serve customer needs for both newly developed products in a pilot plant providing clinical materials, to well-understood large scale commercial production in BRIC countries."