About this archived opportunity

MARKET RESEARCH PURPOSES ONLY NOT A REQUEST FOR PROPOSAL OR SOLICITATION The U.S. Food and Drug Administration (FDA), Office of Acquisitions and Grants Services (OAGS) is issuing this source sought announcement on behalf of the Center for Devices and Radiological Health (CDRH), in order to determine if there are existing small business sources capable of providing a Protective Clothing Blood Penetration Resistance Tester. Other than small business concerns, especially vendors who may be able to offer domestic products are also encouraged to submit a capability statement that provides company information, as well as information demonstrating that it can meet all of the minimum requirements included below, to include the country of manufacture of products offered. If your firm is considered a small business source under North American Industry Classification System (NAICS) Code 334516 - Analytical Laboratory Instrument Manufacturing; with a Small Business Size Standard of 1,000 employees and you believe that your firm would be able to provide the FDA with the supplies/services described below, please submit an email to Warren.Dutter@fda.hhs.gov. Background: The U.S. Food and Drug Administration (FDA), Center for Devices and Radiological Health (CDRH), Winchester Engineering and Analytical Center Laboratory (WEAC), requires the purchase of one (1) Protective Clothing Blood Penetration Resistance Tester to support future regulatory testing. The Protective Clothing Blood Penetration Resistance Tester will be used to perform a verification method to test for viral penetration of level 4 medical gowns at the request of CDRH. Level 4 medical gowns provide the highest level of protection against bloodborne pathogens; they are critical in protecting healthcare workers used during risk medical procedures. The gold standard in testing is performed manually and takes specific expertise and an excess of 100 hours to complete. This automated tester would cut hands on time by 75% while increasing consistency and repeatability to the test. Minimum Technical Requirements: Shall provide four (4) independent working positions capable of running four individual tests simultaneously. Shall include an automatic timer capable of initiating and terminating testing without manual intervention. Shall accommodate test samples with minimum dimensions of 70 mm × 70 mm. Shall be capable of achieving a minimum test pressure of 13.8 kPa. Shall provide real-time pressure monitoring during testing. Shall automatically monitor and adjust pressure throughout the test cycle. Shall operate using compressed air. Shall include autoclavable test cells. Shall be capable of processing a minimum of 60 mL of fluid in each test cell. Shall include an integrated touchscreen user interface. Shall be capable of performing testing in accordance with ASTM F1670 and ASTM F1671/F1671M standards. Additional System Requirements: The components and equipment shall be newly manufactured, not used or refurbished, or previously used for demonstration. Offered systems shall be a turn-key solution i.e., the contractor shall be responsible for providing all hardware, components, instruments, computers, software, and that otherwise required to meet these specifications and the FDA’s stated need. The systems shall be delivered with all necessary supplies and accessories required for installation and start-up. The system and associated accessories shall include operations and maintenance manuals covering proper operation, routine maintenance, and troubleshooting for the system and controlling software. All manuals and documentation shall be provided in hard copy and/or electronic format. The Contractor shall provide all labor, travel, and tools to install the equipment at the address provided below, to include shipping. The contractor shall demonstrate upon installation that the item meets or exceeds all performance specifications. Upon acceptance of the system, the contractor shall provide on-site operator training/familiarization. Such familiarization shall include system operations, calibration, optimization, troubleshooting and basic operational maintenance procedures. The Contractor shall provide Installation Qualification (IQ) and Operational Qualification (OQ) documentation and services for the instrument, including execution and documentation of IQ/OQ protocols, to verify that the system is installed and operates in accordance with the manufacturer's specifications and the requirements of this procurement. Systems shall be warranted for not less than one (1) year from FDA acceptance of the system(s). Warranty service shall include troubleshooting capabilities based on complete knowledge of the entire system, and immediate access to replacement parts. Phone and email technical support shall be included for a minimum of one (1) year. Delivery/Place of Performance: FOB Point Destination. All items shall include shipping, handling, installation, IQ/OQ, and inside deli

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