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66 -- Ultra Performance Liquid Chromatograph

Notice Date
Notice Type
Combined Synopsis/Solicitation
334516 — Analytical Laboratory Instrument Manufacturing
Contracting Office
Department of Health and Human Services, Food and Drug Administration, Office of Field Finance & Acquisition Services, HFT-320, 3900 NCTR Road, Jefferson, Arkansas, 72079-9502
ZIP Code
Solicitation Number
Archive Date
Point of Contact
Karen J. Moore, Phone: (870) 543-7479, Marcia O Park, Phone: (870) 543-7405
E-Mail Address
karen.moore@fda.hhs.gov, marcia.park@fda.hhs.gov
(karen.moore@fda.hhs.gov, marcia.park@fda.hhs.gov)
Small Business Set-Aside
This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in FAR 12.6, simplified acquisition procedures and the resultant of a firm fixed price purchase order will include all applicable provisions and clauses in effect through the Federal Acquisition Circular 05-32. The NAICS Code is 334516. This announcement constitutes the only solicitation; a solicitation document will not be issued. This synopsis is to notify contractors that the government is seeking competition in accordance with FAR Part 13.106 for equipment with the following specifications, under the simplified acquisition procedures. Prospective offeror’s are responsible for downloading the solicitation and any amendments. It is the offeror’s responsibility to monitor the FedBizOpps website for the release of any amendments to this solicitation. The Government reserves the right to award a contract without discussions, if the Contracting Officer determines that the initial offer(s) is/are providing the Best Value and discussions are not necessary. This solicitation is issued as a request for Quotation (RFQ). The Food and Drug Administration (FDA) is seeking competition for vendors capable of providing the following: A Ultra Performance Liquid Chromatograph (UPLC) for the Division of Personalized Nutrition and Medicine in Arkansas and a UPLC for the Division of Seafood Science and Technology in Alabama. Instruments must be newly manufactured units, not used or refurbished or previously used for demonstration. Minimum Technical Specifications: Solvent Delivery System The solvent delivery system must have a flow rate range of 0.010-2.0 ml/min, in 0.001 ml increments. It must be able to delivery gradients with eleven gradient curve shapes (linear, 2 step, 4 convex, 4 concave). The Pressure fluctuation must be 0.5% of system backpressure or 50 p.s.i at 10,000 p.s.i. The system must be a binary solvent delivery system, yet allow the user to choose between two mobile phases for each of the two solvent channels. It must have automatic and continuous compressibility compensation, requiring no user intervention. It must have a built in high efficiency, low volume, 6 chamber vacuum degassing system with a separate channel for each mobile phase solvent and 2 channels for Sample Manager wash solvents. The system must have a compositional accuracy is <0.5% and compositional precision is <0.15% RSD or +/- 0.04min SD. The system must also include an automated software assisted purge function for ease of solvent changing and system purging/priming. It must be able to operate at pressures up to 15000 psi up to 1 ml/min, 9000 psi up to 2 ml/min. The system must have an integral, active and programmable plunger seal wash system. The Solvent Delivery System must be able to run, at flow rates above 0.5 ml/min, newer, smaller particle size columns, such as those with sub-2.0um diameter particles. The system must not require any hardware modifications to be able to run these columns. The system must be also able to run HPLC columns with particle sizes of 3.0, 3.5, 5.0, 7.0 um without any modifications to the system hardware. Sample Management System The Sample Management System must be able to accommodate the following sample of configurations without the use of an external sample handling device: 2 x 96 well plates 2 x 384 well plates 2 racks of 2 ml vials (48 vials/rack) 2 racks of 4 ml vials (24 vials/rack) 2 racks of 0.65ml microcentrifuge tubes (48 tubes/rack) 2 racks of 1.5 microcentrifuge tubes (24/rack) It must be able to inject 1 to 99 injections per sample, depending on sample volume available and injection volume, and support up to THREE injections modes : full loop, partial loop and partial loop using needle overfill (PLNO). The sample management system must have a sample delivery precision of 0.3% RSD, with a full injector loop, 5-50 ul. It must be >0.999 coefficient of deviation from 2-10 ul. The system must limit carryover with a specification better than 0.005% or 2.0 nL of the compound assayed, whichever is greater and temperature of the sample compartment must be maintained from 4 to 40 ºC, programmable in 1 ºC increments. Miscellaneous Requirements: The system control software must be qualified for use in a Pharmaceutical environment. The vendor must be able to provide and, if necessary, perform Installation Qualification (IQ), Operational Qualification (OQ) for each component of the HPLC system (including software) and Performance Qualification (PQ) for the entire system. The system must have diagnostic capabilities, it must be able to export diagnostic data and allow the user to access all diagnostic functions through a graphical interface. Price: The vendor shall provide a price in accordance with the requirements of the technical specifications. The proposed price shall also include the manufacturer’s two year for parts and labor. Evaluation factors for selection of a UPLC system are as follows: Award will be made to the vendor whose quote offers the best value to the Government, technical, price and other factors considered. The Government may award this purchase order to other than the lowest price technically acceptable quote therefore descriptive literature that must be sufficient enough that questions would not have to be asked of the vendor or a search for supplemental literature would not be necessary should accompany quote. The Government will evaluate information based on the following evaluation criteria: 1) Technical Capability factor “Meeting or Exceeding the Requirement,” Past Performance and 2) Price. Technical Capability significantly is more important than price. The FDA intends to make an award immediately after the response date of this notice. The award will be made in accordance with FAR Part 13, Simplified Acquisition Procedures. PROVISIONS and CLAUSES: The provisions at FAR 52.212-1, Instructions to Offerors Commercial Items applies to the solicitation. The following agenda has been attached to this provision: NONE. The clause at FAR 52.212-3, Offeror Representations and Certifications, Commercial Items and FAR 52.212-4, Contract Terms and Conditions, Commercial Items applies to this acquisition. The following Agenda has been attached to this clause: NONE. The clause at FAR 51.212-5 Contract Terms and Conditions Required to Implement Statues or Executive Orders, Commercial Items applies to this acquisition. The following FAR clauses cited are applicable: FAR 52.217-8, FAR 51.222-26, FAR 52.222-35, FAR 52-222-36. Clauses and provisions are incorporated by reference and apply to this acquisition. CCR: Vendor must be registered in the Central Contractor Registration (CCR) prior to the award of a contract. You may register by going to www.ccr.gov. You will need your Dun & Bradstreet number and banking information.
Web Link
FBO.gov Permalink
Place of Performance
Address: 3900 NCTR Road, Jefferson, Arkansas, 72079, United States
Zip Code: 72079
SN01837698-W 20090607/090605235639-9f842e0fc644f04172f841fb06fac9ba (fbodaily.com)
FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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