SSJ PharmaGard - Comfort_Redacted.pdf
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- Solicitation number
- N0018926XXXXX
About this file
This is a Justification for Sole Source document under simplified procedures for a federal procurement on behalf of the U.S. Navy. The contracting activity seeks to acquire a PharmaGard NU-PR797-400 Compounding Aseptic Isolator (CAI) manufactured by NuAire, Inc. (CAGE Code 58194) as a primary engineering control designed for ISO Class 5 positive-pressure pharmaceutical compounding environments aboard naval hospital ships. The CAI features a sealed, glove-box design with HEPA-filtered laminar airflow and meets USP 797 standards for sterile compounding.
The procurement is justified as a sole source acquisition under FAR 12.102(a) because the CAI unit is standardized across the Navy's hospital ship platform (USNS Comfort and USNS Mercy) and is the only authorized unit approved for pharmacy spaces aboard these vessels. The justification cites standardization requirements, space mounting constraints, fitment compatibility with existing systems, alignment with AMAL 6234 pharmacy equipment standards, and the fact that current units are beyond their life expectancy. The estimated procurement value and specific contract value are redacted. The required delivery date is 15 September 2026 in support of the Continuing Promise 2026 mission in the Southern Command Area of Responsibility. The sole source justification precludes full and open competition, with no substitutes available for the specified supplies and services.
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| File | Type | Posted |
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| Synopsis.pdf |
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Source Selection Information – See FAR 2.101 and 3.104
☒ The supplies or services must be compatible in all aspects (form, fit and function) with existing systems presently installed/performing. Describe the equipment/function you have now and how the new item/service must coordinate, connect, or interface with the existing system.
The new CAI unit must adhere to current AMAL 6234, Pharmacy Equipment and Durable Consumables assemblage standards.
Other information to support a sole source action:
PharmaGard NU-PR797-400 by Nuiare is the only authorized unit approved for hospital ship platforms due to standardization, space mounting and fitment. In addition, pharmacy durables and consumables are directly aligned with this unit and would cause waste of funds if another unit was purchased.
TECHNICAL/REQUIREMENTS CERTIFICATION:
I CERTIFY THAT THE INFORMATION PROVIDED ABOVE IS COMPLETE AND ACCURATE TO THE BEST OF
MY KNOWLEDGE. I UNDERSTAND THAT THE PROCESSING OF THIS SOLE SOURCE JUSTIFICATION
PRECLUDES THE USE OF FULL AND OPEN COMPETITION.
I HEREBY DETERMINE THAT THE CIRCUMSTANCES JUSTIFYING ONLY ONE SOURCE IS REASONABLY
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