HEPA Transfer System

INTENT TO SOLE SOURCE:
This notice announces the intent by the U.S. Army Medical Research Acquisition Activity (USAMRAA) in support of the Walter Reed Army Institute of Research (WRAIR), Pilot Bioproduction Facility (PBF), to procure HEPA Transfer Cart (with accessories) without competition as prescribed in FAR 13.106(b)(1)(i). Specifically, the Government will procure this system manufactured by Integrated Containment Systems. The required HEPA Transfer system can only be purchased from Integrated Containment Systems who has no resellers.

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.

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). The 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 manufacturer 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. 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.

The North American Industry Classification System (NAICS) for this requirement is 339112 and FSC 6515.

Proposed solicitation number: W81XWH-18-R-0122.

This announcement fulfills the synopsis requirements under FAR 5.102(a)(6) and 5.203(a). USAMRAA intends to publish a solicitation no sooner than 15 days after publishing this synopsis. This Special Notice of Intent is not a request for competitive quotes. Information received in response to this notice will be considered solely for the purpose of determining whether a competitive procurement is in the best interest of the Government. If no written
responses are received by the date listed below, which reflects at least fifteen (15) days after the publication of this notice, the solicitation will be issued as sole source.

All questions and responses concerning this notice shall be emailed to Ayi Ayayi at ayi.j.ayayi.civ@mail.mil.

Interested concerns must identify their capability in writing to the email address listed above no later than 4:00 PM ET, 20 September 2018.

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