TSI AeroTrak®+ Portable Airborne Particle Counters, Model A100-50

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.