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PRIME CONTRACT

Definitive Contract - W911QY21C0065

OVERVIEW

Awardee
Original Description
SBIR PHASE I
Place of Performance
Austin, TX USA
Pricing
Fixed Price
Set Aside
Small Business Set Aside - Total (SBA)
Extent Competed
Full And Open Competition After Exclusion Of Sources
Related Opportunity
None

SBIR DETAILS

Research Type
Small Business Innovation Research Program (SBIR) Phase I
Title
Innovative Approach to Produce Shatter Resistant Auto-Injector Formula Containers
Abstract
Impact cracks and checks in Type I glass cartridges arising from damage during manufacturing, handling, and transportation can be prevented by incorporating a shrinkable, high-clarity elastomeric sheath around the exterior of the cartridge. Rx Bandz proposes to explore the addition of an energy-absorbing polymer jacket to the exterior of the cartridge surface, augmenting its strength and destroying defective units in production. Rx Bandz will design, develop, and test Type I 1mL cartridges reinforced with a perfluoroalkoxy (PFA), fluorinated ethylene propylene (FEP), or silicon jacket. These materials were considered for their shrink recovery, energy absorption and ease to integrate into a medical device. Assembly of the sheath over the cartridge will take advantage of the shrink recovery of the proposed elastomers by first expanding the sheath and then allowing it to recover around the cartridge. The compression of the recovered elastomer on the foot and shoulder of the cartridge permanently secures the sleeve. During assembly of the sheath, the elimination of critical defects resulting from upstream manufacturing processes is also considered. Destroying unidentified defective cartridges by exposing them to forces defined by the shrinking sheath will prevent failure during operation. This approach not only increases ruggedness and reliability, but also benefits from the low-cost and low-risk provided by maintaining a standard Type I pharmaceutical glass as the primary container. Rx Bandz' solution does not change properties of the glass or expose the pharmaceutical to new materials, which allows for leveraging existing data to demonstrate compliance with ISO 11608-1, ISO 13926, ISO 70788, and USP 661 (protection, delamination, chemical composition, compatibility, clarity, quality, etc). This low-risk design's success in increasing ruggedness by using energy absorption to protect brittle materials against impact and vibration is well documented. Energy absorption protects the glass from cracks and scratches that would increase criticality and weaken strength. Strength property of glass is not constant, but rather defined by its surface quality arising from the defect disturbances. Eliminating and preventing these defects are essential to mitigate the risk of a cartridge fracturing during use. A protection system of this type increases the ruggedness and reliability of the cartridge during the lifetime of the auto-injector.
Topic Code
CBD202-003
Solicitation Number
20.2
Contact
Myrna Walsh
(806) 690-3101
Myrna@RxBandz.com

STATUS
(Complete)

Period of Performance

5/12/21

Start Date

11/12/21

Current End Date

11/12/21

Potential End Date
100% Complete

Obligations

$167.5K

Total Obligated

$167.5K

Current Award

$167.5K

Potential Award
100% Funded

AWARD RELATIONSHIPS

Definitive Contract

W911QY21C0065

Subcontracts

-

Definitive Contract

W911QY21C0065

Subs

-

ACTIVITY TIMELINE

SUBCONTRACT AWARDS

Opportunity Lifecycle

HISTORY

COMPETITION
Solicitation Procedures
Negotiated Proposal/Quote
Number of Offers Received
2
Other Than Full and Open Competition
None
Evaluated Preference
None
Commercial Item Acquisition
Commercial Item Procedures Not Used
Simplified Procedures for Commercial Items
No

OTHER CATEGORIZATIONS

Subcontracting Plan
Plan Not Required
National Interest Action
None
IT Commercial Item Category
Not Applicable
AGENCY DETAIL
Created By
susan.e.ruzicka2.civ.w911qy@mail.mil
Last Modified By
susan.e.ruzicka2.civ.w911qy@mail.mil
Approved By
susan.e.ruzicka2.civ.w911qy@mail.mil
Awarding Office
W911QY W6QK ACC-APG NATICK
Funding Office
W56XNH W6DZ JPMO CBD JPMO MCS (06)

LEGISLATIVE MANDATES

Clinger-Cohen Act Compliant
No
Construction Wage Rate Requirements
Not Applicable
Labor Standards
Not Applicable
Materials, Supplies, Articles & Equipment
Not Applicable
Last Modified: 7/8/21


PIID: W911QY-21-C-0065