PORTABLE XRF ANALYZERS

This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Subpart 12.6, in conjunction with Far 13.5 as applicable and as supplemented with additional information included in this notice. This announcement constitutes the only solicitation. This is a Request for Quotations (RFQ); a written solicitation will not be issued. The Food and Drug Administration, Center for Drug Evaluation and Research has a requirement for the following: Handheld X-Ray Fluorescence Spectrometers 5 Ea $________ $_________ Specifications Five (5) handheld x-ray fluorescence spectrometers that meet or exceed the following specifications: Instrument specifications: 1. Handheld format, weighing less than 10 pounds, and battery operated. 2. Capable of measuring x-ray fluorescence from elements Magnesium through Uranium. 3. The instrument must include a portable central processing device that is capable of controlling the instrument. A single, portable central processing unit must be capable of supporting the measurement of all elements from magnesium through uranium. The central processing unit must be capable of storing data, and transferring data to other computers. The central processing unit must be capable of data transfer by standard USB connection or by Bluetooth wireless data transfer. 4. The instrument must use an x-ray tube source with a rhodium anode. The x-ray tube is required for safety (i.e., the instrument must not have a radioactive source) and the rhodium anode is required for measurement of high Z elements. Rhodium is also required because it is not commonly found in pharmaceutical materials, and will therefore not interfere with detection of potential metal impurities in pharmaceutical products. 5. The instrument detector must be capable of collecting and analyzing x-rays at high count rates, exceeding 100,000 x-ray counts per second. This is required to increase signal-to-noise ratio and decrease measurement time. 6. Instrument bandwidth should not exceed 145 eV full width at half maximum, measured at the manganese K-alpha line at a signal rate typical of routine measurements. This is required to reduce overlap of nearby peaks in the XRF spectrum, and thereby improve the quantitative accuracy and detection limit of the instrument. A pertinent measure of detection limit can be demonstrated by the following procedure, which tests the capability of the instrument to measure lead in the presence of a large bismuth background: (a) Measure and report the unprocessed XRF spectrum of 10 ml of liquid Pepto Bismol (Original Strength) over the 9-15 keV spectral range using a 5 minute integrated collection time. (b) Measure and report the unprocessed XRF spectrum of 10 ml of liquid Pepto Bismol (Original Strength) spiked with 0.2 ml of a 10,000 part per million lead standard solution over the 9-15 keV spectral range using a 5 minute integrated collection time. (c) Report the difference spectrum between (b) and (a) without smoothing. (d) Measure and report the unprocessed XRF spectrum of 10 ml of liquid Pepto Bismol (Original Strength) spiked with 0.02 ml of a 10,000 part per million lead standard solution over the 9-15 keV spectral range using a 5 minute integrated collection time. (e) Report the difference spectrum between (d) and (a) without smoothing. The detection limit will be determined from the difference spectra as the extrapolated concentration that results in a signal-to-noise ratio of 3, the signal being measured as the peak of the lead 10.5 keV line, and the noise being measured as the root mean squared average noise of the spectrum. 7. The instrument must include user-controlled calibration facilities, including selection of up to at least 25 elements for analysis. The calibration sequence must allow the user to specify concentrations of elements in standard samples for user-defined calibrations. User-defined calibration options must include linear, quadratic, cubic and higher order polynomial calibration equations. 8. The instrument must have user-controlled instrument control including source voltage and current, and user selectable filters. 9. Instrument must have at least 5 fixed internal filters. 10. Instrument must allow the user to develop methods that utilize at least three filters in a programmable sequence, with user specified calibration. 11. The instrument must be capable of storing sets of user-specified instrument parameters and calibration parameters to support user-generated analytical methods. 12. The instrument must be capable of operation in pass/fail mode on the basis of user-selected calibration and user-specified threshold concentration. 13. The instrument must be capable of operation in fundamental parameters mode. 14. The handheld instrument must include additional portable equipment necessary to facilitate the sensitive determination of light elements, including magnesium, aluminum, silicon, phosphorous, sulfur, chlorine, potassium, calcium and scandium with high sensitivity. 15. The instrument must include a stand to support the instrument on a benchtop. 16. Instrument must include an interface to a user supplied computer via USB or similar common interface. The instrument must include desktop computer software for analysis and display of data from the handheld instrument. Desktop software should allow direct control of the handheld XRF spectrometer for calibration and method development. 17. Include one year parts and labor warranty. 18. Include on-site training. The solicitation number is FDA-SOL-08-00858. Quotations are due by September 8, 2008, by 2:00 p.m. Central Daylight Time in Jefferson, AR; at Food and Drug Administration, OC/OSS/OFFAS, Attention: Sandra Davis, 3900 NCTR Rd., Jefferson AR 72079-9502. The North American Industry Classification System (NAICS) Code is 334516 and the size standard is 500 employees. The award will be made on the basis of full and open competition from among all responsible business concerns submitting offers. All responsible sources may submit a quotation, which if received timely, shall be considered by the Agency. Offers must reference solicitation number FDA-SOL-08-00858. Contract Type: Commercial-Item Firm Fixed Price, using simplified acquisition procedures. FOB Point of Delivery for equipment and supplies provided will be Food and Drug Administration, 1114 Market Street, RM 1002, St. Louis, MO 63101 Offerors must include a completed copy of the provisions at FAR 52.212-3, Offeror Representations and Certifications - Commercial Items with its offer. Applicability of FAR Provisions: the following Federal Acquisition Regulation (FAR) provisions and clauses apply to this request for quotes and are incorporated by references. The solicitation document and incorporated provisions and clauses are those through Federal Acquisition Circular (FAC) 2005-26 dated June 12, 2008. COMMERCIAL CLAUSES IN ACCORDANCE WITH FAR PART 12 - INCORPORATED IN FULL TEXT: 52.212-1 Instructions to Offerors'Commercial Items (June 2008) 52.212-2 - Evaluation - Commercial Items (JAN 1999) (a) The Government will award a contract resulting from this solicitation to the responsible offeror whose offer conforming to the solicitation will be most advantageous to the Government, price and other factors considered. The following factors shall be used to evaluate offers: Technical, Price and Past Performance. Technical and past performances, when combined, are equal to cost. The technical quotations will receive paramount consideration over cost and past performance; however, cost will be evaluated for price reasonableness. Each offeror must (1) submit written information that pertains to their capability to supply the required equipment, (2) identify two sources for which the offeror has provided the same or similar items that are required herein (include contracts within the past two years, Points of contact and telephone numbers). The Government may make its decision on the basis of initial quotations received and not have discussions. Therefore, each initial quotation should contain the offeror's best terms from both a price and technical standpoint. Offerors shall include technical specifications, descriptive material, literature, brochures and other information corresponding to each minimum required item, which demonstrates the capabilities of the offeror. The Government is not responsible for locating or securing any information, which is not identified in the proposal. Before the offer's specified expiration time, the Government may accept the offer (or part of an offer), whether or not there are negotiations after its receipt, unless a written notice of withdrawal is received before award. 52.212-3 - Offeror Representations and Certifications - Commercial Items (June 2008) 52.212-4 - Contract Terms and Conditions'Commercial Items (Feb 2007) 52.212-5 - Contract Terms and Conditions Required to Implement Statutes or Executive Orders'Commercial Items (June 2008): The following additional FAR clauses cited in this clause are applicable: 52.222-3; 52.222-21; 52.222-26; 52.222-35; 52.222-36; 52-222-37; 52.222-50 and 52.232-33 Clause and provisions can be obtained at HTTP://WWW.ACQUISITION.GOV CCR Requirement - Offeror's must be registered in the Central Contractor Registration (CCR) before an award can be made. If offeror's are not registered in CCR, they may do so by accessing the CCR web site at: http://www.ccr.gov. Period of Performance - Within 60-90 days after receipt of purchase order. A standard commercial warranty on parts and workmanship is required. The Defense Priorities and Allocation System (DPAS) and assigned rating are not applicable to this solicitation notice.