Retrofit to Glatt GCG-70 Inline Continuous Screw Blender-Mixer for Signal Exchange

The U.S. Food and Drug Administration is seeking information from qualified vendors to assess industry capability, availability, and interest in providing retrofit hardware and integration services for the Glatt GCG-70 Inline Continuous Screw Blender-Mixer. The retrofit is required to enable the equipment to communicate with other existing office equipment or systems and to integrate with a supervisory control system. The contractor shall provide all labor, materials, equipment, transportation, and supervision necessary to retrofit the Glatt GCG-70 Dry Mixer to enable communication and signal exchange with third-party equipment. The key requirements include enabling electronic communication with the SIMATIC PCS 7 Distributed Control System, allowing remote control of blender speed, and providing a minimum one-year warranty. Some key points to consider are: • The equipment lacks the capability to communicate with other existing equipment or systems. • The retrofit is essential to support the New Drug Application (NDA) and Abbreviated New Drug Application (ANDA) review processes for continuous manufacturing applications. • The contractor shall ensure that the GCG-70 retrofit meets the specified salient characteristics. • The deliverables include retrofit hardware, commissioning and qualification, and documentation.