This Pre-Solicitation opportunity from Department Of Health And Human Services was posted on July 29, 2026. The submission period has ended. Browse the details below for market research, or find similar active opportunities.
TSI AeroTrak®+ Portable Airborne Particle Counters, Model A100-50
Contract Overview
Solicitation details, issuing organization, response deadlines, documents, and interested companies for this government contract opportunity.
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AI Contract Overview
The National Cancer Institute is proceeding with a sole source procurement of four TSI AeroTrak+ Portable Airborne Particle Counters, Model A100-50, under FAR 6.302-1, due to the absence of any other responsible source capable of meeting its specific regulatory and operational needs. These instruments are critical for non-viable airborne particle monitoring in the Surgery Branch T30 Cell Production Facility, a cGMP-compliant environment where patient safety and product integrity depend on strict environmental controls aligned with ISO 14644-1, ISO 21501-4, EU GMP Annex 1, and FDA regulations. TSI Incorporated, as the original equipment manufacturer, is the only provider that can supply the exact model with factory-authorized Installation and Operational Qualification services, proprietary accessories, and manufacturer-supported warranty coverage required to maintain validated operations and regulatory compliance without disruption. Standardization on the TSI AeroTrak+ Model A100-50 is essential to preserve continuity with existing environmental monitoring protocols, personnel training, calibration procedures, and historical data records. Introducing an alternative device would necessitate costly revalidation, documentation revisions, and extensive retraining, posing unacceptable risks to ongoing manufacturing activities and compliance status. While the acquisition is planned as a sole source award, the government is inviting capability statements from any responsible party through August 7, 2026, to assess whether competition is feasible—though any decision not to compete remains at the government’s discretion. The award is anticipated within five days after the response deadline, with all submissions directed to haunp@mail.nih.gov, and the contract will be performed at the facility in Bethesda, Maryland.
General Info
Agency
NAICS
Place of Performance
Bethesda, MD, 20892, USASet-Aside
Documents
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Timeline
Submission Closed
Organization & Contact Information
Full Description
Authority: FAR 6.302-1 – Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements
Contracting Activity:
National Cancer Institute
Proposed Contractor:
TSI Incorporated
Description of Requirement:
TSI AeroTrak®+ Portable Airborne Particle Counters, Model A100-50
Justification for Sole Source:
NCI intends to negotiate and award a sole source contract to TSI Incorporated pursuant to FAR 6.302-1, Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements.
This acquisition is for four (4) TSI AeroTrak®+ Portable Airborne Particle Counters, Model A100-50, including all required accessories and Installation Qualification/Operational Qualification (IQ/OQ) services, to be procured on a sole source basis from TSI Incorporated, the original equipment manufacturer (OEM).
The TSI AeroTrak®+ Model A100-50 is required to support non-viable airborne particle monitoring for cleanroom classification, routine environmental monitoring, and ongoing regulatory compliance within the National Cancer Institute (NCI) Surgery Branch T30 Cell Production Facility (CPF). The CPF is a current Good Manufacturing Practices (cGMP) facility used to manufacture and process cell therapy products intended for patient infusion. Maintaining a controlled manufacturing environment is essential to ensuring product quality, regulatory compliance, and patient safety.
These particle counters are required to meet mandatory monitoring and certification requirements established by ISO 14644-1, ISO 21501-4, EU GMP Annex 1, applicable FDA current Good Manufacturing Practice (cGMP) regulations, and 21 CFR Parts 210 and 211. Four units are necessary to simultaneously monitor multiple classified cleanroom areas and aseptic processing operations, ensuring continuous compliance during manufacturing activities and environmental qualifications.
TSI Incorporated is the only source capable of providing the required AeroTrak®+ Model A100-50 particle counters, proprietary accessories, factory-authorized IQ/OQ services, and manufacturer-supported warranty coverage. The IQ/OQ services must be performed using TSI-approved procedures and documentation to ensure the equipment is installed, qualified, and validated in accordance with manufacturer specifications and regulatory expectations. Procurement from any other source would not provide the OEM-certified equipment, qualification documentation, or factory-authorized support required to maintain validated operations within the CPF.
Standardizing on TSI AeroTrak®+ instruments also maintains compatibility with the facility's existing environmental monitoring program, established standard operating procedures, personnel training, calibration practices, and historical monitoring data. Introducing an alternate manufacturer's equipment would require extensive revalidation activities, revisions to controlled documentation, retraining of personnel, and demonstration of data equivalency, resulting in unnecessary cost, schedule delays, and potential disruption to manufacturing operations.
For these reasons, no other source can satisfy the Government's minimum requirements without unacceptable technical, operational, and regulatory risk.
Notice to Interested Parties
This notice is not a request for competitive quotations or proposals. However, any responsible source, including small businesses, 8(a) firms, HUBZone small businesses, service-disabled veteran-owned small businesses (SDVOSBs), women-owned small businesses (WOSBs), veteran-owned small businesses (VOSBs), and small disadvantaged businesses (SDBs), may submit a capability statement demonstrating its ability to satisfy the Government's requirement.
Capability statements will be evaluated solely to determine whether a competitive procurement should be conducted. A determination by the Government not to compete the proposed requirement based upon responses to this notice is solely within the Government's discretion.
Anticipated Award
The Government anticipates making an award approximately five (5) calendar days after the closing date of this notice unless the Government determines that another responsible source is capable of satisfying the Government's requirements.
Capability statements must be submitted via email to haunp@mail.nih.gov no later than 9:00 a.m. EDT on August 7, 2026.
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