DM-KCM and K-Vision Installations to Coperion K-Tron Feeders

The Office of Pharmaceutical Quality Research seeks to integrate five Coperion K-Tron continuous powder feeders—three QT20 units, one KT20 unit, and one MT12 unit—into a continuous manufacturing line by installing Human Machine Interface (HMI) controllers known as K-Tron Control Modules (KCMs) and connecting them to the K-Vision operator interface. These components are essential for centralized monitoring and control of all feeders under supervised conditions, enabling real-time process oversight and ensuring consistent product quality. The current integration platform lacks dedicated mounting space for the five KCMs, requiring physical and electrical modifications to accommodate them, along with full network connectivity between the KCMs and K-Vision to enable seamless, unified operation. This installation is critical for advancing regulatory science in pharmaceutical manufacturing by supporting the adoption of continuous process monitoring and control technologies that enhance process robustness and risk mitigation. The effort is formally forecasted under the title DM-KCM and K-Vision Installations to Coperion K-Tron Feeders, issued by the Food and Drug Administration’s Center for Drug Evaluation and Research. The work falls under NAICS code 334516 for the manufacture of industrial process control equipment and is intended to modernize pharmaceutical production capabilities through regulatory science innovation. The point of contact for program inquiries is the Cder Acquisition Liaison at cderacquisitions@fda.hhs.gov, while the contracting officer position remains to be filled. The forecast was posted on May 25, 2026, indicating a future procurement opportunity aimed at enabling fully integrated, supervised continuous manufacturing operations within the FDA’s research environment.