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FBO DAILY ISSUE OF JULY 31, 2011 FBO #3536
SOLICITATION NOTICE

66 -- X-Ray Spectrometery

Notice Date

7/29/2011
 

Notice Type

Combined Synopsis/Solicitation
 

NAICS

334516 — Analytical Laboratory Instrument Manufacturing
 

Contracting Office

Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services, Bldg 50 Room 422, Jefferson, Arkansas, 72079, United States
 

ZIP Code

72079
 

Solicitation Number

1089977
 

Archive Date

8/23/2011
 

Point of Contact

Karen J. Moore, Phone: (870) 543-7479
 

E-Mail Address

karen.moore@fda.hhs.gov
(karen.moore@fda.hhs.gov)
 

Small Business Set-Aside

N/A
 

Description

Notice Type: Combined Synopsis/Solicitation Set Aside: Total Small Business Synopsis: This is a combined Synopsis/Solicitation for commercial items prepared in accordance with the Federal Acquisition Regulation (FAR) format in Subpart 12.6 as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued. The solicitation number is 1089977. This solicitation is issued as a Request for Quote (RFQ) and is set aside for small businesses. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2005-53, 5 July 2011. The associated North American Industry Classification System (NAICS) Code is - 334516 - Analytical Laboratory Instrument Manufacturing; Small Business Size Standard is 500 in number of employees. Respondents are responsible for delivery in person, by email, fax, mail or other delivery method their complete proposal and any additional documents before 3:00 pm (Central Standard Time - Local Prevailing Time in Jefferson, Arkansas) on August 8, 2011 to Karen.moore@fda.hhs.gov Fax (870) 543-7990, or mail to the U.S. Food and Drug Administration, OC/OSS/OAGS, Attention Karen Moore, 3900 NCTR Road, Jefferson, AR 72079-9502. PLEASE NOTE: The above contact information is for the Contracting Office and not necessarily the delivery address. The delivery address is indicated in the FOB Destination section below. When appropriate, Respondents should consult with delivery providers to determine whether their documents will be delivered prior to the scheduled time. For information regarding this solicitation, please contact Karen J. Moore by email at Karen.moore@fda.hhs.gov. The Food and Drug Administration is soliciting quotes for an X-ray (XRF) spectrometry capable of detecting metals in drugs at the part per million (ppm) level. This technology can be used to identify metal impurities in pharmaceutical materials that can reduce the shelf life of pharmaceutical products. The technical requirements are: 1) The instrument must be small enough to sit on a typical laboratory bench. 2) The instrument should only require 110 volt power, 15 amps. The instrument should be air cooled and not require cooling water or liquid nitrogen for operation. 3) The instrument must be capable of measuring x-ray fluorescence from elements Sodium through Uranium. 4) The instrument must be capable of measuring a variety of samples including loose powders, pressed tablets, capsules, liquids, suspensions, etc. 5) Ideally the instrument will be capable of single part per million detection limits for cadmium, arsenic, lead and mercury in a variety of matrices. 6) The instrument must use an x-ray tube source capable of supporting X-ray fluorescence measurement of high Z elements including palladium, Ruthenium, rhodium, osmium, iridium and platinum. The x-ray tube should generate at least 50 watts of radiation, and have an operating voltage that can reach at least 50 kilovolts. 7) 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. 8) The instrument must have an energy dispersive detector with a bandwidth not to exceed 150 eV full width at half maximum, measured at the manganese K-alpha line at a signal rate of not less than 100,000 counts per second. 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. 9) A pertinent measure of detection limit and bandwidth capability can be demonstrated by the following procedures, 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 ((c) and (e) above ad the extrapolated concentration that results in a signal-to-noise ration 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. 10) The instrument must have user-control of source voltage and current. 11) The instrument must have an automated sample holder that automatically advances to the next sample after a measurement is complete, with at least 12 positions for 12 separate samples. Additional sample carrousels with fewer positions that allow measurement of larger samples may also be included. 12) Instrument must have at least 5 secondary targets and source polarization elements, to support sensitive measurement of elements from sodium through uranium. The instrument must be able to automatically switch between secondary targets during a typical measurement of a single sample to cover all elements. 13) The instrument must have a facility to purge the region between the sample, detector and x-ray tube with nitrogen or helium. 14) The instrument must include a complete computer system (e.g., computer, monitor, mouse, keyboard, etc.) required for operation, including instrument control software and software to develop calibration models based on fundamental parameters and empirical parameters. 15) The software should be user friendly and easy to operate. Facilities to develop qualitative and quantitative methods and standardless semiquantitative methods are desirable. 16) The instrument must include radiation shielding and safety interlocks that protect the user from exposure to x-ray radiation. 17) Price should include one year parts and labor warranty. 18) Price should include installation and on site training. Installation must include installation qualification and operational qualification (IQ/OQ). 19) Price should include any cost for shipping and handling. TRADE AND SERVICE CRITERIA: 1. The instrument must be new, neither a demonstration model nor a refurbished instrument. The life cycle of this instrument is intended to be greater than ten years at full performance. The Food and Drug Administration must be able to reasonably expect service and technical support from the vendor during its lifecycle. 2. The instrument must have one (1) year of warranty and support from the date of installation. The vendor shall provide a copy and pricing for any available extended warranties and service contracts. The vendor must be also capable of servicing the accessory through the period of any purchased extended warranty or service contract. This information shall not obligate the FDA to purchase an extended warranty. 3. The instrument must have 24/7 days a week technical support should a problem arise. Unit Price:_______________________ Extended Price:___________________ Make:___________________________ Model:__________________________ Part Number:_____________________ GSA Contract Number (if applicable):_________________________________ FOB Destination - Food and Drug Administration, 1114 Market Street, Room 1002, St. Louis, MO 63103 Contract Type - Commercial Item - Firm Fixed Price - Simplified procurement procedures will be utilized. An official authorized to bind the Offeror must sign the terms and conditions of the offer. Offerors that fail to furnish required representations and certifications, or reject the terms and conditions of the solicitation, may be excluded from consideration. CCR REQUIREMENT - Company must be registered on the Central Contractor Registration (CCR) before an award could be made to them. If company is not registered in CCR, they may do so by going to CCR web site at http://www.ccr.gov The provision at FAR 52.212-1 Instructions to Offerors - Commercial Items applies to this solicitation. The provision at FAR 52.212-2 Evaluation-Commercial Items is applicable to this solicitation. The specific evaluation criteria to be included in paragraph (1) of that provision are as follows: The Government will award a contract resulting from this solicitation to the responsible offeror whose offer conforming to the solicitation will be the most advantageous to the Government, price and other factors considered. The following factors shall be used to evaluate offers: (i) Technical capability of the items offered to meet the Government's requirement, which includes in order of importance, the following: Degree to which the vendor meets or exceeds the detailed technical specifications. Emphasis will be placed on the sensitivity of the instrument to lead, mercury, arsenic and cadmium. Ability of the vendor to demonstrate that their instrument has been used successfully for analyzing trace metals in pharmaceuticals. (ii) Price The government will award an order to the lowest price technically acceptable quote. Technical acceptable will be determined by review of information submitted by the quoter which are listed above. The government is not responsible for locating or securing any information, which is not identified in the proposal. To ensure information is available, vendors must furnish as part of their proposal all descriptive material necessary for the government to determine whether the service meets the technical requirements. Quotes 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 provision at FAR 52.212-3, Offerors Representations and Certifications-Commercial Items, applies to this acquisition. An offeror shall complete only paragraph (b) of the provision if the offeror has completed the annual representations and certifications electronically at http://orca.bpn.gov The clause at 52.212-4, Contract Terms and Conditions - Commercial Items, applies to this acquisition. The following addenda have been attached to the clause: None The clause at FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders-Commercial Items, applies to this acquisition. The following additional FAR clauses cited in this clause are applicable: 52.222-2, 52.222-19, 52.222-21, 52.222-36, 52.225-3, 52.225-13, and 52.223-33. Clauses and provisions are incorporated by reference and apply to this acquisition. Clauses and provisions can be obtained at http://www.arnet.gov CCR Requirement - Company must be registered on Central Contractor Registration (CCR) before an award could be made to them. If company is not registered in CCR, they may do so by going to CCR web site at http://www.ccr.gov The Defense Priorities and Allocations Systems (DPAS) and assigned rating are not applicable to this solicitation notice.
 

Web Link

FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/NCTR/1089977/listing.html)
 

Place of Performance

Address: 1114 Market Street Room 1002, St. Louis, Missouri, 63101, United States

Zip Code: 63101
 

Record

SN02515718-W 20110731/110729235312-6437bde8b2f8b7306a72703543abb35c (fbodaily.com)
 

Source

FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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