2_JA 2127576 Nuaire Airegard.pdf

Justification for Other than Full and Open Competition:

Brand Name at or Below the Simplified Acquisition Threshold

Project Title: ___AireGard NU-140-430 Vertical Laminar Airflow Workstation____

I . Identification of the agency and contracting activity

DHHS, NIH, NIAID, _VRC, VPP_______

Address of the requesting lab/office: 9W Watkins Mill Road, Ste #250, Gaithersburg, MD 20878

II. Description of the project, and supplies or services required to meet the agency’s needs A. Project Background

The Vaccine Production Program (VPP) is the development arm of the Vaccine Research Center (VRC). The mission of the VRC is to create and develop potentially lifesaving vaccines for HIV, Ebola, Zika, Malaria, SARS-COV-2 and other known pathogens and get these potentially lifesaving products into the clinic.

To support clinical product development, specifically clinical in-use stability studies, VRC vaccines must be compounded in IV bags and syringes in a sterile, ISO Class 5 environment as described in USP Chapter 797. The VPP requires the procurement of a Laminar Flow Hood with 8 feet of continuous workspace, enabling execution of these procedures. Laminar flow hoods are designed specifically in accordance with ISO Class 5 guidelines, enabling protection of vaccine samples and containers from particulate contamination. Acquisition of this equipment by the VPP Formulation group will provide new capabilities for clinical support rt studies, increase productivity, and minimize risk of sample contamination.

B. Description of the supplies/services to be purchased

The VPPL requires the procurement of an 8-foot Laminar Flow Hood with 8 feet on continuous workspace, enabling procedures that require two operators (smaller hoods will not meet requirements). AireGard NU-140-430 Vertical Laminar Airflow Workstation is an 8-foot unit, that is manufactured and shipped as two 4-foot units that are assembled as a single continuous 8-foot unit on site. The design allows the moving and installation of the equipment inside the building. The laminar flow hood is equipped with electric outlet and IV bar, which are required for the clinical in-use stability studies conducted in formulation group. The equipment produces a constant airflow across the surface, which predictably sweeps particles in a uniform direction from the cleanest area under the hood to the exit area, which is generally the sash opening. Airborne contamination is filtered through HEPA filters. The design ensures that the cleanest area will always be the upstream area closest to the filter face.

III. Identification of the statutory authority permitting other than full and open competition (SELECT ONE)

☒ 41 USC 3304(a)(1) a n d F A R P a r t 6 . 3 0 2 - 1 : Only one responsible source/Brand Name

IV. Demonstration that the proposed contractor(s) unique qualifications or the nature of the acquisition requires use of the authority cited.

A. Name and address of the proposed contractor(s)

Manufacturer: NuAire, Inc. 2100 Fernbrook Lane, Plymouth, MN, 55447, US

B. Describe why only the requested brand or brand name feature of the supply/service will meet the government’s needs

NuAire Vertical Laminar Airflow Work Station is the only laminar flow hood currently available on the market that meets all the following end-user’s requirements:

1) Eight feet of useable workspace (manufactured as two 4-foot units that are combined to create 8 continuous feet of workspace – two separate 4 foot units do not meet requirement).

2) Vertical Laminar Flow (Horizontal does not meet requirements)

3) Capable of creating an ISO Class 5 environment under normal working conditions.

4) Constructed from 16/18 gauge, Type 304 stainless steel to ensure compatibility with required cleaning procedures.

5) Filtration by HEPA filter protected by a perforated metal diffuser, to meet Federal pharmaceutical compounding requirements.

6) Filtration replacement available via front filter removal through the work zone without exterior disassembly (required for use in available facility space).

7) Option available for IV Bar with 6 stainless steel hooks available inside the hood.

8) Option available for electrical outlet within 12 inches of sash opening.

9) Positive pressure plenums surrounded by a vacuum relative to the room.

10) Meets the requirements of both the U.S. and Canada for electrical/mechanical integrity.

V. Certification This is to certify that the justification for the proposed acquisition has been reviewed and that to the best of my knowledge and belief the information and/or data provided to support my request (for the requestor) and approval (for the CO) of is accurate and complete.

Official Name & Title Signature Date

Requestor Certification

Contracting Officer Approval