SOURCES SOUGHT
66 -- Brand Name or Equal Waters Acquity UPLC system with heart cutting capability
- Notice Date
- 6/20/2013
- Notice Type
- Sources Sought
- NAICS
- 334516
— Analytical Laboratory Instrument Manufacturing
- Contracting Office
- Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services, 5630 Fishers Lane, Room 2129, Rockville, Maryland, 20857-0001
- ZIP Code
- 20857-0001
- Solicitation Number
- FDA-RFI-1118803
- Point of Contact
- Juana Quinteros, Phone: 3018276764
- E-Mail Address
-
Juana.Quinteros@fda.hhs.gov
(Juana.Quinteros@fda.hhs.gov)
- Small Business Set-Aside
- N/A
- Description
- General Information: Document Type: SOURCES SOUGHT NOTICE Release Date: June 20, 2013 Response Date: June 24, 2013 at 4:30pm EST, via e-mail Contracting Office Address: Food and Drug Administration (FDA), Office of Acquisition and Grant Services Description: Brand Name or Equal Waters Acquity UPLC system with heart cutting capability NAICS Code: 334516--Analytical Laboratory Instrument Background: This is a SOURCES SOUGHT NOTICE to determine the availability of potential small businesses (e.g., 8(a), service-disabled veteran owned small business, HUBZone small business, small disadvantaged business, veteran-owned small business, and women-owned small business) in accordance with FAR 7.104(d). The potential small business will need to demonstrate the capability to provide a Brand Name or Equal Waters system with heart cutting capability. This request is for information and planning purposes only and shall not be construed as a solicitation or as an obligation on the part of the Food and Drug Administration (FDA) for any future solicitation. No official solicitation exists; therefore, please do not request a copy of a solicitation. If in the future an official solicitation is released, there is no guarantee that sources responding to this will be included on the source list. Telephone inquiries will not be accepted. The FDA makes no implied or in fact contract by issuing this RFI. Acknowledgement of receipt of responses will not be made, nor will respondents be notified of the FDA's view of the information received. Do not send any material that requires a non-disclosure agreement or that may be business sensitive. Responses received that include a non-disclosure agreement or identify information that is business sensitive will not be accepted. Responses to this notice will not be returned. Mission and Objectives: The Office of Regulatory Science at CFSAN-FDA is involved in development of new and robust approaches to solve complex problems pertaining to food safety. Our scientists develop full range of analytical methods and tests for the identification and quantification of substances/ contaminants/ additives in food and dietary supplements. The purpose of this acquisition is to purchase a brand name or equal Waters Acquity UPLC system. Technical Capability Is your company able to provide the following: 1) A primary pump. - Must be capable of pumping separately two solvents and blending them thereafter. - Must deliver the blended solvent at a flow rate from at least 0.010 to 2.000 mL/min. - For flow rates comprised in the 0.2 to 2.0 ml/min interval, the precision must be lower than 0.01 SD or 0.080% RSD, whichever is greater. - The pump must allow starting the elution gradient at a defined time before, simultaneously, or after the sample injection. - Up to the flow rate of at least 2.000 ml/min, the pump must be capable of delivering eluent at backpressures reaching at least 18000 PSI. - Each of the two compressors must allow the selection of 2 solvents stored in separated bottles, for a total of 4 solvents. - The pump must be equipped with a separate online degasser per each solvent line. -The pump must be equipped with a high pressure blender/mixer, with a volume not greater than 50 mcL. - The pump must be capable of delivering the blended 2 solvents following linear and non linear gradients. The number of selectable gradient curve shapes must be at least 11. 2) A sample manager, or auto injector. - The auto injector must be configured with the "flow through needle" design. - The auto injector must be capable of operating under the same flow rate/backpressure specifications of the primary pump. - The sample chamber or holder must be temperature controlled, allowing regulation of the temperature in the 4-40°C range with 1°C precision. - The sample manager carryover must be not greater than 0.002%. - The sample chamber/holder must shield samples from light, while waiting for their injection. - The auto injector must be capable of injecting sample portions included in the range of at least from 0.1 to 10 mcL. 3) Temperature controlled column compartment. - Must accommodate two columns having dimensions up to 4.6 mm I.D. and up to 150 mm length. - Must allow controlling the temperature from 20C to 90C. - Must allow pre-heating of the eluent before the separation column. - Must allow communication with the Waters eCord device which accompanies the UHPLC column we are currently using. This device stores the usage information of the separation column. - The connecting tubing composing the flow path must be in 0.003 inch internal diameter. 4) Secondary quaternary UHPLC pump. - Must be able to deliver eluent at a flow rate of at least from 0.020 to 2.000 ml/min. - Must be capable of dynamically blend 4 solvents at low pressure, before the high pressure compressor. - Must be able to deliver the blended eluent at a backpressure up to 15000 PSI at a flow rate up to 2.000 ml/min. - Must be equipped with an online degassing unit, with a separate chamber per each solvent line (4). 5) DAD detector. - Must be capable of acquiring simultaneously the absorbance signal in the wavelength range of at least from 200 to 800 nm, with a spectral resolution of at least 1.2 nm. - Must be capable of operate with 250 nL and 500 nL flow cells. - The controlling software must allow the independent control of filter settings and acquisition data rate. 6) 6 ports two position valve, for heart cutting applications. - must be fully controlled by the chromatography software, allowing coordinate hearth cutting from the first column eluent and injection to the second separation column. - must be capable of operating at the flow rates/pressures specified for the pumps/injector described above. - must include all the components (i.e. controllers, power suppliers, cables) to be operational in the chromatographic system. 7) Fraction collector. - plumbed after the DAD detector, must allow the collection of the eluent from the separation column in separate containers. - Must be capable of collecting fractions into containers of various sizes, from standard test tubes to large (250-500 ml) bottles. - Must be equipped with a 3 way valve, which deviates the stream to waste when the eluent is not collected. - Must be controllable through the chromatography software. - Must be able to operate at flow rates from 0.1 to 10 mL/min. 8) Computer software operating the system. - Must be capable of simultaneously controlling all the above described components, and coordinate them in a comprehensive method of analysis. - Must be able of acquiring and storing the detector signal, process the acquired data to provide quantification results, and build reports. - Must be able of operating under the Windows 7 OS platform. - Must be able to independently control at least two chromatographic systems. - Must allow access to the software to at least 5 users. Size of Business State whether your company is a large business, small business (and also state your under socioeconomic status), College/University, or a non-profit organization. Estimated Dollar Value Range Based on the government's mission, objectives, and scope of work, what dollar value range would you determine to be the most accurate rough estimate. Under $100,000.00 Over $100,000.00 and Under $150,000.00 Over $150,000.00 and Under $200,000.00 RFI Instructions This is not an invitation for bid, request for proposal or other solicitation and in no way obligates FDA to award a contract. The sole intent of this Sources Sought Notice is to obtain capabilities for set-aside and procurement planning purposes. Please provide the follow Business information: 1. DUNS Number; 2. Company Name; 3. Company Address; 4. Company Point of Contact, phone number and email address; 5. Type of company under NAICS, as validated via the System for Award Management. Additional information on NAICS codes can be found at www.sba.gov. Any potential government contract must be registered on the SAM website located at http://www.sam.gov; 6. Corporate structure (corporation, LLC, sole proprietorship, partnership, limited liability partnership, professional corporation, etc.); 7. Current GSA Schedules appropriate to this Sources Sought; 8. Current Government Wide Agency Contracts (GWACs); 9. Point of Contact, phone number and email address of individuals who can verify the demonstrated capabilities identified in the responses; 10. Responders should also include a statement about whether or not they have an approved Federal audited accounting system. If the responder has an approved accounting system, please provide the certification in which the accounting system was deemed adequate (e.g. the name of the audit agency and audit number). You may submit as an attachment, which will not count towards the overall page limit; Interested parties having the capabilities necessary to perform the stated requirements may submit capability statements via email to Attn: Juana Quinteros, Contract Specialist at Juana.Quinteros@fda.hhs.gov. CAPABILITY STATEMENTS MUST DEMONSTRATE THE MINIMUM REQUIREMENTS OUTLINED ABOVE. Please address each in order listed above. All capability statements shall be submitted via e-mail to the point of contact listed above. Responses shall be limited to 3 pages. Responses must be submitted no later than 6/24/13.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/FDA-RFI-1118803/listing.html)
- Place of Performance
- Address: 5100 Paint Branch Parkway, College Park, Maryland, 20740, United States
- Zip Code: 20740
- Zip Code: 20740
- Record
- SN03094854-W 20130622/130620235002-f3b2a3da64a794a803c21c8a35ab7c27 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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