Blood Plasma Spray Drying System

Title:  Blood Plasma Spray Drying System

This is a Notice of Intent to Sole Source an award on the basis of other than full and open competition in accordance with 10 United States Code (U.S.C.) 3204(a)(1) as implemented in FAR 6.302-1(b)(1)(i), Unique supplies or services available from only one source or only one supplier with unique capabilities.

This is not a Request for Quotes or Proposals. No contract award will be made on the basis of the responses to this notice. The purpose of this notice is to allow interested parties to assert and explain their capability to satisfy the requirement described.

The U.S. Army Medical Research Acquisition Activity (USAMRAA) located at 808 Schreider

Street, Fort Detrick, MD on behalf of the US Army Institute of Surgical Research (USAISR), intends to award a sole source firm fixed price contract to Velico Medical, Inc. for a Velico FrontlineODP System.  The product is a blood plasma spray drying system and market research has identified it as the only available product that meets the USAISR’s needs.  The anticipated award date is 1 June 2025.

Required Capabilities:

The Blood Plasma Spray DryingSystemmust meet the following Minimum Essential Characteristics (MECs):

The system should contain a spray dryer, a sealer and the plastic consumable components that are sterile-docked to blood plasma bags in a completely closed, aseptic process. The system should be able to produce a dried plasma product in bag suitable for transfusions. The system will need to be able to produce a product suitable for clinical transfusions without the need for a sterile room. System should be able to produce a spray dried unit of plasma greater than or equal to 48g.

Additionally, the system should meet the following specifications/MECs:

A. Modular equipment with no more than 3 separate units (Dryer, Sealer, Clean Dry Air System).

B. Drying Modular Unit Specifications

1. Equipment should have dimensions equal to or smaller than 32x25.2x77.5 (DxWxH) inches.
2. The weight of the equipment should be less than 560 pounds.
3. The electrical requirement should be 208VAC at 60hz and 30amps.
4. Equipment should utilize an L6-30P connector.
5. Unit should have an air flow of at least 800 SLPM (Standard Liters Per Minute).
6. The operating pressure should be between 90-120 pounds per square inch (psi).
7. Equipment should have a dedicated exhaust.
8. Equipment should be capable of operating in 15-40˚ C temperatures with relative humidity less than or equal to 75%.
9. The safe operating altitude should be between sea level and 6,750 feet.
10. The recommended operating pressure should be between 0.95-1.05 atmospheres.
11. The recommended operating noise should equal to or less than 65 decibels.
12. Should operate with an integrated, simple user interface

C. Sealing Modular Unit Specifications

1. The sealing modular unit should have dimensions equal to or less than 34.7x29.3x77 (DxWxH) inches.
2. The weight of the equipment should be between less than 550 pounds.
3. The voltage of the equipment should be 208VAC at 60hz and 20amps.
4. The equipment should utilize a L6-30P connection for electricity.
5. The air requirements for the devices should be 90-105psi and it should utilize a quick disconnect adaptor.
6. Equipment should be capable of operating in 15-40˚ C temperatures with relative humidity less than or equal to 75%.
7. The safe operating altitude should be between sea level and 6,750 feet.
8. The recommended operating pressure should be between 0.95-1.05 atmospheres.
9. The recommended operating noise should equal to or less than 70 decibels.

D. Utilizes a clean Dry Air System

1. Oil-free air compressor.
2. Desiccant dryer.
3. Air-tank.
4. Ancillary filters.

E. Utilizes single-use consumables.

1. Equipment should come with 50 to 470 units of plasma drying chambers.
2. Equipment should come with 50 to 470 units of plasma pretreatment containers.
3. Equipment should come with 50 to 470 units of sterile water for injection.
4. Equipment should come with 50 to 470 units of transfer sets.
5. Equipment should come with 50 to 470 units of packing including desiccant.

Eligibility

The applicable North American Industry Classification System (NAICS) code for this requirement is 334519 - Other Measuring and Controlling Device Manufacturing. The Product Service Code (PSC) is 6695 - Combination and Miscellaneous Instruments.

Submission Details

If a vendor challenges the basis for this requirement, please submit a capability statement that includes sufficient detail and with convincing evidence that clearly demonstrates the capability to provide a Blood Plasma Spray Drying Systemwith all required capabilities and that meets all MECs.  Responses should appear on company letterhead and include affirmation of active registration in the System of Award Management (SAM)  and indicate whether they are a large business, small business, small disadvantaged business, 8(a) concern, woman-owned small business, HUBZone, service disabled veteran-owned small business, or qualify as socially or economically disadvantaged and whether they are U.S. or foreign owned.

Responses shall be submitted via email to jeremy.l.mcmurry.civ@health.mil in either Microsoft Word or Portable Document Format (PDF) no later than 12:00 PM Eastern Standard Time on 9 March 2025 and reference this Notice ID number in the subject line of your e-mail and on all enclosed documents. All data received in response to this Notice of Intent that is marked or designated as corporate or proprietary will be fully protected from any release outside the Government. Responses to this notice will be used to determine the availability of this type of product and/or service. All responsible sources may respond to this notice and all responses will be considered by the agency. Information and materials submitted in response to this request WILL NOT be returned.