SSJ_Hepa_Transfer_Cart_Revised_06_SEP_2018_Redacted.pdf

Control No:

"For Official Use Only”

Sole Source Justification (SSJ) in accordance with FAR subparts 13.106 or 13.5 using

Simplified Acquisitions Procedures (SAP)

1. Contracting Activity: The Contracting Activity responsible for this action is the US Army Medical Research Acquisition Activity (USAMRAA), Fort Detrick MD.

2. Requiring Activity: The Requiring Activity for this action is the Walter Reed Army Institute of Research (WRAIR), Pilot Bioproduction Facility (PBF).

3. Nature of Action:

Commercial Item Non-Commercial Item New Requirement Follow-on Requirement Mod to Existing Purchase Order/Contract Number

Pricing: Firm-Fixed Price* Time & Materials** Cost*

* See FAR 12.207(a) ** See FAR 12.207(b).

For Hybrid Contracts, list percentage of each type of pricing:

* Firm Fixed Price: ________

**Time & Materials: ________

* Cost: ________

Funds: RDT&E Operations and Maintenance, Army (OMA)

Other Funds:

Fiscal Year of Funds: ____

Estimated Total Dollar Value including Options:

4. Contractor Name:

Name of Proposed: Contractor(s):

Street Address:

City, State, Zip:

Phone:

DUNS:

Cage Code:

5. Description of Supplies/Services: The HEPA Transfer Cart and the 4 x 4 Cleanroom Module are a combination, customized pairing of equipment. The Transfer Cart is a self-contained Class 100 enclosure with a particle counter. The unit is designed for transport of product from classified areas through unclassified areas back to a classified area. The Cleanroom Module is an integrated containment system for the cart that Allows transfer of aseptic filled vaccine from a Class 100 BSC into the HEPA Tranfer Cart while providing a continual Class 100 air environment during transfer. This continuous Class 100 environment is a cGMP requirement for open vaccine product.

6. Authority Cited: 41 U.S.C. 1901 OR 41 U.S.C. 1903

(a) FAR 13.106-1(b)(1)(i): Only one source reasonably available (e.g., urgency, exclusive licensing agreement, brand name or industrial mobilization); OR

(b) FAR 13.106-1(b)(1)(ii): Only one source can provide a portion of the purchase that is a particular brand-name item; OR

(c) FAR 13.501(a)(1)(i): Only one source reasonably available (including brand name); OR

(d) FAR 13.501(a)(1)(ii): Only one source can provide a portion of the purchase that is a particular brand-name item.

7. Reason for Authority Cited: This system is a requirement to allow the PBF to produce manually-filled vaccine material when circumstances prevent them from putting the material into the automated fill line (e.g. a live virus vaccine or other material that may cause a cross-contamination risk, or vial sizes for which we do not have fill line change parts). A HEPA transfer cart is required to move materials between the Biological Safety Cabinet and the lyophilizer because the background air quality is lower than that required by FDA for open product transfer. Due to space constraints and room configuration, the transfer cart must be custom made to fit the space and needs of the PBF. The Current manufacture is the only vendor capable of providing the customized piece of equipment to meet the specific specification based on the outline and the space provided within the PBF.

The system itself must be equipped with an access opening composed of one Lexan sliding door and silicone gaskets to function with the current operating procedures within the current facility. This unit must also be supplied with an integrated particle sampling port that can be connected to an external particle sampler currently used, such as the MetOne system. The Integrated Containment Systems unit is the only manufacturer that can provide the combination of needs in this customized system.

If the PBF does not acquire this system, vaccine materials will be exposed to both increased risk of contamination and also actual loss of manually filled vaccine due to much less than optimal vaccine material transfer alternatives. This can adversely impact all end users and ultimately significantly reduce the capability of the PBF to vial aseptic vaccines and possibly significantly decrease the client base of the PBF.

There is no alternative to the HEPA Transfer Cart that can be connected to the existing MetOne system external particle sampler currently used, and accommodate the existing room configuration.

8. Efforts to obtain Competition: Not applicable. No effort will be made to solicit offers as there is only one source that can be assured to provide the proper specifications to ensure that the cart will work with the MetOne system external particle sampler already in use in the facility. A Notice of intent to sole source will be posted to FedBizOpps for 15 days prior to award.

a. Effective competition. No effective competition is anticipated. Current Market Research has identified that no alternatives exist for this item.

b. Subcontracting competition. No subcontracting is expected..

9. Actions to remove or overcome barriers Competition: WRAIR will continue to explore alternative options for this requirement.

10. Market Survey: WRAIR conducted market research through the System for Award Management (SAM) and on multiple search engines using multiple key terms and criteria specific to this effort. We found no other businesses that were able to meet the PBF requirement. Internet searches were also conducted, including a search of GSA Advantage and ECAT, to determine if any other vendors were capable of meeting the requirement as well as other means of procuring this item. Based on the results of the market research, Integrated Containment Systems was the only vendor identified that could meet all of the mission essential characteristics needed for this requirement.

11. Interested Sources: To date, no other sources have written to express an interest in this requirement.

12. Procurement History and any other facts:

Previous Contract or Purchase Order Number: N/A

Previously competed? No, this contract was previously not competed.

Previous authority for less than Full & Open Competition: No.

13. Technical / Requirements Certification: I certify that the support data under my cognizance which are included in this SSJ are accurate and complete to the best of my knowledge and belief.

Submitted by Signature:

Printed name:

Agency/Position/Title:

Date:

14. Contracting Officer Certification and Approval: I certify that this justification is accurate and complete to the best of my knowledge and belief. Based upon the facts described herein, I hereby determine that the anticipated price/ cost to the Government will be fair and reasonable, and a determination of price reasonableness will be documented and placed in the contract file.

Contracting Officer Signature:

Printed name:

Agency/Position/Title:

Date: