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FBO DAILY ISSUE OF AUGUST 24, 2006 FBO #1732
MODIFICATION

66 -- 320 KV X-Ray System

Notice Date

8/22/2006
 

Notice Type

Modification
 

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, MD, 20857-0001
 

ZIP Code

20857-0001
 

Solicitation Number

1019275
 

Response Due

8/25/2006
 

Archive Date

9/9/2006
 

Point of Contact

Joseph Pishioneri, Contract Specialist, Phone 301-827-7109, Fax 301-827-7101, - Elizabeth Osinski, Contracting Officer , Phone 301-827-7043, Fax 301-827-7101,
 

E-Mail Address

joseph.pishioneri@fda.hhs.gov, elizabeth.osinski@fda.hhs.gov
 

Small Business Set-Aside

Total Small Business
 

Description

This is modification number one to the combined synopsis below: Section III, Item 10 provides further detail on mounting instructions. Due to the modification, the deadline for quotes has been extended until Friday, August 25th 2006. 10) Vendor shall provide a mounting surface on the front of the Cabinet consisting of a vertically flat, square surface of no less than 2500 square centimeters and capable of withstanding a pressure of at least 200 grams per square centimeter without fatigue or failure. There will be two bolt holes in this mounting surface along the horizontal center line positioned at least 20 centimeters apart. Each bolt hole will be capable of supporting 100 kilograms without fatigue or failure. The center point between the two bolt holes will be vertically inline with the X-ray exit port and will be at least 40 centimeters below the X-ray exit port but no more than 70 centimeters below the X-ray exit port. When a bracket is attached to this mounting surface with a load of 100 kilograms positioned 30 centimeters from the mounting surface, the Cabinet will meet all other specifications in this document and will not present a stability risk. THIS IS A COMBINED SYNOPSIS/SOLICITATION FOR COMMERCIAL ITEMS PREPARED IN ACCORDANCE WITH THE FORMAT IN FAR SUBPART 12.6-STREAMLINED PROCEDURES FOR EVALUATION AND SOLICITATION FOR COMMERCIAL ITEMS-AS SUPPLEMENTED WITH ADDITIONAL INFORMATION INCLUDED IN THIS NOTICE. THIS ANNOUNCEMENT CONSTITUTES THE ONLY SOLICITATION; QUOTATIONS ARE BEING REQUESTED, AND A WRITTEN SOLICITATION DOCUMENT WILL NOT BE ISSUED. THIS SOLICITATION IS BEING ISSUED USING SIMPLIFIED ACQUISITION PROCEDURES. This solicitation is a Request for Quotation (RFQ). The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 05-11. The associated North American Industrial Classification System (NAICS) code for this procurement is 334516. The acquisition is 100% set-aside for small business. To qualify as a small business, the manufacturer and the distributor must be classified as a small business under the NAICS code identified above. This acquisition being procured using full and open competition. All interested quoters shall provide a quote for: Line Item 0001, One (1) 320 KVP x-ray system: General Description Constant potential x-ray generator and X-ray tube suitable for providing a reference x-ray field for calibration of radiation monitors for the FDA NVLAP accredited X-ray Calibration Laboratory. General Requirements The generator will be controlled by an existing FDA computer system using PC based LabView software. The vendor shall provide and install all connectors, hoses, and wiring needed for integration and functionality of the cooling pump, x-ray tube and generator. The control module shall provide means to disallow operation of the x-ray system at technique factors which would result in damage to the x-ray tube. Vendor shall install appropriate audio and visual safety indicators as required by state and federal regulations. Safety interlock system shall terminate x-ray production, and shall be independent of computer system. Bid responses must include all available advertising literature, technical manuals, and diagrams. I) Specifications for Comet MXR-321 Industrial X ray Tube, or equivalent 1) The tube shall be Metal Ceramic construction, and shall have a minimum rating of 4000 Watts. 2) The rated kilovoltage range shall be from 16 kV to 320 kV. 3) The focal spot size shall be 5 mm2 (former focal spot designation) or 8 mm2 (Focal spot acc. EN 12543). 4) The anode shall be stationary and oil cooled. 5) The anode material shall be tungsten. 6) The maximum anode current shall be at least 12 mA from 30 kV to 320 kV. 7) The anode angle shall be not less than 22o. 8) The emergent beam angle shall be not less than 40o. 9) The total inherent filtration shall be ≤ 3.0 mm Be. II) Specifications for Isovolt Titan 320 High Voltage Generator and Control Module or equivalent 1) The generator shall provide both a regulated constant potential tube bias and a regulated filament supply suitable for a Comet MXR-321 Industrial X ray Tube or equivalent. 2) The system must operate using existing power capabilities that are at the FDA facility. Either of the following can be used: 208 VAC, 3Φ Y, 60 Hz, 20 A or 400 VAC 3 Φ Y, 60 Hz, 20 A. 3) Both the x-ray tube voltage and current shall be closed-loop controlled from direct measurements of the generator output parameters. 4) The generator shall be capable of continuous operation at 320 kVp and 20 mA. 5) The output voltage shall have a minimum range of 16 to 320 kV and shall be fully regulated over this range. 6) The x-ray tube current shall have a minimum range of 0.05 to 12 mA and shall be fully regulated over this range. 7) The output voltage shall have a short term stability of ?0.05% or better in one hour, and a long term stability of ?0.1% or better. These limits shall not be affected by line voltage fluctuations up to ?10%. 8) The x-ray tube current shall have a short term stability of ? (0.05% + 0.001 mA) or better in one hour, and a long term stability of ? (0.1% + 0.002 mA) or better. These limits shall not be affected by line voltage fluctuations up to ?10%. 9) The reproducibility of the output voltage and tube current shall be ?0.1% or better. 10) The accuracy of the output voltage and tube current shall be ?2% or better. 11) The output voltage ripple envelope shall not exceed 150 V peak-to-peak at 12 mA or less for any normal operating conditions (this includes both the high frequency and line frequency). 13) System must include Isovolt Titan Control module or equivalent. The generator shall be digitally controlled through an RS232 or IEEE-488 computer interface. All functions and indications shall be provided for manual operation, independent of an external computer. 14) Through the interface port, the kilovoltage and tube current shall be selectable in steps no greater than 0.1 kV and 0.01 mA respectively, over the entire range. IMPORTANT: Bid responses must unequivocally state the resolution of the kV and mA demand. 15) Upon request from the controlling computer, the actual kilovoltage and current applied to the tube shall be returned with a resolution of 0.1 kV and 0.01 mA respectively, or better. IMPORTANT: Bid responses must unequivocally state the resolution of the kV and mA feedback. 16) All of the generator control functions shall be available through the interface port. This includes all command and status functions. The safety system, including interlock inputs and "x-ray on" status signals, shall be independent of the computer interface. 17) An analog output from the voltage divider shall be provided. This signal shall be suitable for observing the high voltage ripple on an oscilloscope. 18) Two instruction manuals shall be included. The manuals shall include a complete set of schematic diagrams. 19) Upon shutdown of the x-ray system, the oil cooling pump shall provide two minutes of cool down time for the x-ray tube. 20) A built-in real-time clock shall track the operating history and calculate the appropriate time needed for the warm-up cycle. 21) Vendor shall provide and install a manual power switch inside the room for the x-ray generator AC power. III) Specifications for Custom Shielded Cabinet with high speed x-ray shutter that will house Comet MXR-321 Industrial X ray Tube, or equivalent 1) Collimation of the exit beam to provide good beam geometry for 6 cm2 filter packs and transmission monitor. 2) High Speed shutter: Transient shutter time of ≤30 ms. 3) Fully closed and fully1 opened shutter indicator switches. 4) Discrete shutter activation signal customized for integration with FDA computer control system. 5) Leakage Radiation shall be ≤ 0.5 mR/h at 5 cm. 6) X-ray tube yoke that helps facilitate beam alignment. 7) Horizontal or vertical louvers for cables. 8) Shielded housing safety interlock system. 9) Center of X-ray aperture opening to be located 1.25 meters above floor. 10) Vendor shall provide mounts for existing FDA provided transmission monitor and filter wheel. FDA will provide needed information to facilitate this process. 11) A fixture capable of holding a 2.25? diameter disc for positioning apertures at the center of the exit beam on the shielded x-ray tube cabinet shall be provided. IV) Specifications for GE water-recooled oil circulation Pump OW 4002 or equivalent that is compatible with a Comet MXR-321 Industrial X ray Tube, or equivalent 1) A safety circuit shall monitor the cooling oil supply to the x-ray tube. The circuit shall include a fail-safe oil turbine flow rate monitor, which opens the circuit in case a minimum flow rate of the cooling oil (17 l/min) is not ensured. Reset of switch shall be automatic. 2) A thermostat switch opens the circuit in case the cooling oil temperature exceeds the set temperature (50?C). Reset of switch shall be automatic. 3) Vendor shall integrate oil cooling system into FDA furnished chilled water system. Accessories shall include, but are not limited to all Vendor Standard Delivery Scope items, as well as Input and output connections for all sections listed above. V) Delivery, Shipping and Installation Vendor shall provide and include cost for the following: Shipping to FDA White Oak Facility. Be responsible for the moving and installation of all parts. Training of multiple users on the use of the x-ray system. Warranty: Minimum of 1 year warranty of all parts and labor after installation. Award shall be made to the vendor whose quote meets all required technical specifications as determined by a review of documentation submitted in accordance with this solicitation and quotes the lowest price. Evaluation of Technical Capability shall be based on the information provided in the quotation. Vendors providing quotes shall include the manufacturer, make and model of the product, manufacturer sales literature or other product literature which CLEARLY DOCUMENTS that the offered product meets or exceeds the specifications stated herein. The full text of the FAR provision or clause may be accessed electronically at http://acquisition.gov/comp/far/index.html. The following provision applies to this acquisition: FAR 52.212-1, Instructions to Offerors-Commercial Items. The following clauses apply to this acquisition: 52.204-7 Central Contractor Registration 52.212-4 Contract Terms and Conditions-Commercial Items; 52.212-5 Contract Terms and Conditions Required to Implement Statutes or Executive Orders-Commercial Items including subparagraphs: 52.219-6, Notice of Total Small Business Set-Aside 52.222-3, Convict Labor 52.222-19, Child Labor-Cooperation with Authorities and Remedies 52.222-21, Prohibition of Segregated Facilities 52.222-26, Equal Opportunity 52.222-36, Affirmative Action for Workers w/Disabilities 52.225-1, Buy American Act-Supplies 52.225-2, Buy American Act-Certificate 52.225-13, Restrictions on Certain Foreign Purchases 52.232-33, Payment by Electronic Fund Transfer-Central Contractor Registration. All vendors providing quotes should also submit the following: 1). An original and one (1) copy of a quotation which addresses Line Item 0001. 2). Two (2) originals of technical description and/or product literature. All quotes must be sent to the Food and Drug Administration, OAGS, Attn: Joe Pishioneri, 5630 Fishers Lane, Room 2091, HFA-500, ROCKVILLE, MD 20857. Vendors providing quotes shall ensure the RFQ number is visible on the outermost packaging. Submission must be received by 3:00 p.m. EST on Tuesday, August 23, 2006. E-MAIL QUOTES TO Joseph.Pishioneri@fda.HHS.GOV WILL BE ACCEPTED, HOWEVER, MUST INCLUDE ALL REQUIRED INFORMATION. FAX QUOTES WILL NOT BE ACCEPTED.
 

Place of Performance

Address: FDA, Twinbrook Pkwy, Rockville

Zip Code: 20852

Country: UNITED STATES
 

Record

SN01121798-W 20060824/060822220414 (fbodaily.com)
 

Source

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

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