GEA North America LLC ConsiGma standalone Process Analytical Technology (PAT) Rig, or equivalent
Overview
Buyer
Place of Performance
NAICS
PSC
Set Aside
Original Source
Timeline
Qualification Details
Fit reasons
- NAICS alignment with historical contract wins in similar service areas.
- Scope strongly matches core technical capabilities and delivery model.
Risks
- Past performance thresholds may require one additional teaming partner.
- Potential clarification needed on staffing minimums before bid/no-bid.
Next steps
Validate eligibility requirements, assign capture owner, and schedule partner outreach to confirm teaming strategy before submission planning.
Quick Summary
The U.S. Food and Drug Administration (FDA), specifically the Center for Drug Evaluation and Research (CDER), Office of Pharmaceutical Quality Research (OPQR), is seeking a GEA North America LLC ConsiGma standalone Process Analytical Technology (PAT) Rig, or an equivalent instrument. This equipment is required to expand an existing integration platform for continuous manufacturing (CM) of oral solids. Quotes are due by June 17, 2026.
Opportunity Overview
This combined synopsis/solicitation (RFQ) aims to procure a PAT Rig that enables in-line property measurements of powder blends and facilitates easier sampling within continuous manufacturing operations. The system must provide smooth, controlled flow of powder blend over a near infrared (NIR) probe for consistent spectra measurement and be adaptable for seamless integration with upstream and downstream unit operations.
Key Requirements
- Product: GEA North America LLC ConsiGma standalone PAT Rig or equivalent.
- Functionality: Smooth, controlled powder flow over NIR probe; adaptable to CM operations; seamless integration.
- Material: Stainless steel product contact surfaces (pharmaceutical grade finish); FDA-compliant non-metal parts.
- Testing & Qualification: Factory acceptance testing, site commissioning, calibration, installation, and operational qualification.
- Portability: Must include casters and brakes.
- Flow Control: Continuously adjustable speed for powder exit.
- Cohesive Powder Handling: Must permit flow without impacting NIR accuracy.
- Warranty: Minimum one (1) year parts and labor from installation/commissioning.
- Manufacturing: Systems must be newly manufactured.
- Turn-key Solution: Contractor responsible for all hardware, components, instruments, computers, and software.
- Installation & Training: Factory-certified personnel for installation and operator training.
- Documentation: Operations and maintenance manuals.
- Accessibility: Compliance with Section 508 for Information and Communication Technology (ICT).
Contract Details
- Contract Type: Firm Fixed-Price for commercial products.
- Period of Performance: Delivery, installation, qualification, and training expected within 280 days of contract award.
- NAICS Code: 334516 – Analytical Laboratory Instrument Manufacturing (Small Business Size Standard: 1,000 employees).
Eligibility & Submission
This is a full and open solicitation, meaning any sized business under the applicable NAICS code may submit a quote.
- Submission Deadline: Quotes must be submitted via email to Suzanne Martella (suzanne.martella@fda.hhs.gov) by June 17, 2026, 3:30 PM Central Time.
- Quote Requirements: Include descriptive material, literature, brochures, and technical specifications. For "equal" products, provide a narrative detailing how each salient characteristic is met. Include Unique Entity ID (UEI) and an Accessibility Conformance Report (ACR) for non-508 compliant items. Offerors agree to hold prices firm through September 30, 2026.
Evaluation Criteria
Award will be made to the lowest priced technically acceptable responsible quoter. Technical acceptability requires sufficient information to demonstrate the quoted product meets or exceeds all specified requirements.