Background
The Office of Pharmaceutical Quality Research (OPQR) supports the modernization of pharmaceutical manufacturing by conducting regulatory science research on emerging technologies. Continuous manufacturing (CM) of oral solids has been recognized as an emerging technology by the FDA. Continuous process monitoring and manufacturing process control are critical for establishment of a robust CM process that can consistently produce product of desired quality, while identifying and mitigating manufacturing risks.
Currently, OPQR possesses a Glatt GCG 70 continuous dry mixer. However, the GCG 70 lacks the capability to communicates with other equipment or systems. To integrate the GCG 70 into a CM line, a retrofit is required to enable it to interface with a supervisory control system. This upgrade will enhance the functionality of the GCG 70.
This package includes both hardware and site services for retrofitting the GCG 70 dry mixer to facilitate signal exchange with other equipment. The retrofitted GCG 70 should be adaptable to CM operation which includes options for the seamless integration of upstream and downstream unit operations. It will also enable synchronized control of process parameters of other unit operations through automatic modulation.
This retrofit is essential to support the New Drug Application (NDA) and Abbreviated New Drug Application (ANDA) review processes for CM applications.
Scope
To retrofit the GCG 70 Dry Mixer to communicate with the other equipment of systems.
Requirements
The GCG 70 retrofit shall meet the following salient characteristics:
- Shall enable electronic communication with SIMATIC PCS 7 distributed control system for integration with other equipment.
- Shall enable setting blender speed remotely, including start/stop, as well as feedback indicating that the blender is running and the actual speed.
- Shall not restrict or inhibit any existing operational capabilities of the GCG 70, including local control capability.
- Shall include one (1) year parts and labor with warranty from date of shipment.
Delivery, Installation, and On-site Commissioning
The vendor will cover all costs associated with the following:
- Hardware packaging, shipping, and delivery.
- On-site hardware installation, commissioning, and qualification.
- On-site assistance with supervisory control system commissioning.
- Updated qualification documents, instruction manuals, drawings/diagrams, and other related equipment documentation for the GCG 70
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- INSPECTION/ACCEPTANCE CRITERIA
Inspection and acceptance shall be in accordance with the base clause 52.212-4(a). Contracting officer’s representative (COR) is responsible for the inspection and acceptance of the deliverables for this requirement.
CONTRACT TYPE
This is firm fixed price.
PERIOD OF PERFORMANCE
The period of performance (POP) is for 180 days after award.
PLACE OF DELIVERY AND PERFORMANCE
U.S. Food and Drug Administration
5901 Ammendale Road
Suite G
Beltsville, MD 20705
Attn: POC to be identified at time of the award.
