Process Analytical Technology (PAT) rig with Near Infrared (NIR) Spectrometer
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) is conducting market research through a Sources Sought Notice (SSN) to identify qualified vendors, particularly small businesses, capable of providing a Process Analytical Technology (PAT) rig with a Near Infrared (NIR) Spectrometer. This is not a solicitation but aims to gather information on available sources for a ConsiGma (or equivalent) system. Capability statements are due by April 24, 2026.
Scope of Work
The FDA requires a Standalone Laboratory PAT Test rig and an NIR Spectrometer.
PAT Rig requirements include:
- Construction from stainless steel and FDA-compliant materials.
- Capability to handle pharmaceutical powders with minimal mixing or turbulence.
- Adaptability to continuous manufacturing operations.
- Minimum one-year parts and labor warranty.
NIR Spectrometer requirements include:
- Construction from stainless steel and FDA-compliant materials.
- Wavelength range of 1200 – 2000 nm.
- Reflection probe with a sapphire window.
- High accuracy and precision.
- Integrated data acquisition and storage system compatible with standard spectral processing software.
- Detachable accessories for reference measurement.
- Minimum one-year parts and labor warranty.
General system requirements:
- Components must be newly manufactured and provided as a turn-key solution.
- Installation by factory-certified personnel.
- Operations and maintenance manuals.
- On-site operator training for at least two attendees.
- Warranty for not less than one year from FDA acceptance.
- Delivery, installation, qualification, and training expected within 40 weeks of contract award.
Submission Requirements
Interested contractors must submit capability statements via email to suzanne.martella@fda.hhs.gov by April 24, 2026, 10:00 am Central Time. Responses should demonstrate capability and include:
- Business information
- Past performance
- Descriptive literature and technical information
- GSA Schedule/BIC contract information (if applicable)
- Place of manufacture Informational pricing is requested but not mandatory.
Eligibility & Set-Aside
The FDA is primarily seeking small business sources, but other interested parties are encouraged to respond. Vendors must be capable of supplying a U.S. product/service from a small business vendor or producer.
Additional Notes
This notice is for planning purposes only and does not constitute a solicitation. Responses with weblinks will not be opened. Do not include proprietary, classified, confidential, or sensitive information. The government reserves the right to use any non-proprietary technical information. Comments regarding potentially restrictive requirements are welcome.