revRequirements Document (3).pdf
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- Solicitation number
- CDER-2026-131716
About this file
This is a Statement of Work (SOW) for the retrofit of a Glatt GCG-70 Continuous Dry Mixer owned by the Food and Drug Administration's Office of Pharmaceutical Quality Research (OPQR). The OPQR supports modernization of pharmaceutical manufacturing through regulatory science research on emerging continuous manufacturing (CM) technologies for oral solid dosage forms. The current GCG-70 mixer lacks communication capability with other equipment and systems, requiring a retrofit to enable integration into a CM production line through interface with a supervisory control system.
The contractor must provide all labor, materials, equipment, transportation, and supervision to retrofit the mixer for signal exchange with third-party equipment. Key requirements include: enabling electronic communication with a SIMATIC PCS 7 Distributed Control System (DCS), allowing remote control of blender speed with start/stop and feedback functionality, preserving all existing operational capabilities including local control functions, providing a minimum one-year warranty covering parts and labor from the delivery date, and supplying updated qualification documentation, instruction manuals, and engineering drawings. Deliverables include retrofit hardware (1 lot), on-site installation services (1 lot), on-site commissioning and qualification (1 lot), and a documentation package (1 lot), with all hardware packaging, shipping, delivery, installation, and commissioning costs incurred by the contractor. The anticipated period of performance is 120 days from contract award, with delivery to Scott Krull at the FDA facility in Beltsville, Maryland (Suite G, 5901 Ammendale Road). The government will review all deliverables against specifications in the SOW, and the contractor must implement necessary changes within 10 business days of receiving change notification.
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Statement of Work (SOW)
Statement of Work (SOW)
Retrofit of Glatt GCG-70 Continuous Dry Mixer
1. 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 solid dosage forms has been recognized by the Food and Drug Administration (FDA) as an emerging technology.
Continuous process monitoring and manufacturing process control are critical for establishing a robust CM process that consistently produces products of the desired quality while identifying and mitigating manufacturing risks.
Currently, OPQR possesses a Glatt GCG-70 Inline Continuous Screw Blender-Mixer for Powders (480 Volts), Glatt (CAT#: STEM-GLEPO-0082-LJX) continuous dry mixer. However, the GCG-70 lacks the capability to communicate with other existing office equipment or systems. To integrate the GCG-70 into a CM production line, a retrofit is required to enable it to interface with a supervisory control system. This upgrade will enhance the functionality and integration capability of the GCG-70.
This requirement includes both hardware and site services necessary to retrofit the GCG-70 dry mixer to facilitate signal exchange with other existing equipment. The retrofitted system shall be adaptable to continuous manufacturing operations and support seamless integration with upstream and downstream unit operations. The retrofit will also enable synchronized control of process parameters across unit operations through automated modulation.
This retrofit is essential to support the New Drug Application (NDA) and Abbreviated New Drug Application (ANDA) review processes for continuous manufacturing applications.
2. Scope of Work
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.
3. Requirements and Deliverables
Item 1 & Item 2: Retrofit of GCG-70 Dry Mixer for Signal Exchange with Third-Party Equipment
The contractor shall ensure that the GCG-70 retrofit meets the following salient characteristics:
• Enable electronic communication with the SIMATIC PCS 7 Distributed Control System (DCS) to allow integration with other equipment.
• Allow remote control of blender speed, including start/stop, with feedback indicating operational status and actual speed.
• Do not restrict or inhibit any existing operational capabilities of the GCG-70, including local control functions.
• Provide a minimum one (1) year warranty, including parts and labor, beginning on the date of delivery.
• Provide updated qualification documentation, instruction manuals, engineering drawings/diagrams, and all related equipment documentation associated with the retrofit.
Item 3: Delivery, Installation, and On-Site Commissioning
The contractor shall incur all costs associated with the following:
• Hardware packaging, shipping, and delivery.
• On-site hardware installation.
• On-site commissioning and qualification.
Deliverables Table
Deliverable Description Quantity Delivery Timeframe
Retrofit Hardware Hardware components required to enable signal exchange between the GCG-70 and third-party equipment
1 Lot Within the period of performance
Installation Services On-site installation of retrofit hardware 1 Lot Upon hardware delivery
Commissioning & Qualification
On-site commissioning and qualification of the retrofitted system 1 Lot After installation
Documentation Package
Updated qualification documents, manuals, drawings, and related documentation 1 Lot At time of commissioning
Warranty Minimum one (1) year warranty including parts and labor 1
Begins upon Government acceptance
4. Delivery Location
Hardware Delivery Location
Attn: Scott Krull Food and Drug Administration
5901 Ammendale Road Suite G Beltsville, MD 20705
5. Place of Performance
Attn: Scott Krull Food and Drug Administration 5901 Ammendale Road Suite D Beltsville, MD 20705
6. Period of Performance
The period of performance shall begin upon contract award and continue through completion of delivery, installation, commissioning, and qualification of the retrofitted GCG-70 system.
The anticipated period of performance is 120 days from the date of award, unless otherwise agreed upon by the Government and the Contractor.
7. Inspection and Acceptance
The Government will review all deliverables in accordance with the specifications and standards identified in this SOW and any directives issued by the COR.
• The contractor shall submit deliverables to the COR according to the delivery schedule.
• The contractor shall implement any necessary changes within 10 business days of receiving change notification.
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