Loren Data's SAM Daily™

FBO DAILY ISSUE OF AUGUST 29, 2009 FBO #2835
MODIFICATION

66 -- 10 Station Glove Water Test System

Notice Date

8/27/2009
 

Notice Type

Modification/Amendment
 

NAICS

339112 — Surgical and Medical 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

72079-9502
 

Solicitation Number

1060420
 

Archive Date

9/19/2009
 

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

Total Small Business
 

Description

This is a combined synopsis/solicitation for commercial items prepared in accordance with the Federal Acquisition (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. This requirement is being issued in conjunction with FAR part 13 Simplified Acquisition Procedures, as applicable. This solicitation is issued as a Request for Quote (RFQ). The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2005-36. The associated North American Industry Classification System (NAICS) code is 339112-Surgical and Medical Manufacturing. Small Business Size Standard is 500 employees and is set aside for small business concerns. The Food and Drug administration is soliciting for a contractor to provied a 10 Glove Station Water Testing System and Spare parts. The Minimum requirements are: Each of the ten (10) test positions will feature a volumetric piston based cylinder for improved accuracy, and calibration and repeatability. The cylinder will be connected by flexible tubing to the holding tubes, which are designed to secure the gloves with a manually applied polymer ring or trap. The control system allows the fill sequence to be offset, based upon the time required to inspect the glove providing a consistent hang/test time between stations. Indicator lights located at each test position indicate the status of the station. Red (Not ready), Flashing Green (Alert Operator that observation period is approaching) and Green (Observation period is active). After the observation period is over the sequence flashes alternate Red/Green (Observation period is ending) and Red (Observation period is over). Each sequence duration is programmable through the control system and will repeat for each of the ten stations upon initiation of each cycle. A flashing Red light indicates a station is deactivated and should be skipped during the observation period. Specifics for machines and spare parts: _ Anodized Aluminum frame for corrosion resistance with leveling feet, casters, fluorescent lighting and a mirrored rear splash panel for improved inspection viewing of gloves. Testing frame designed to fit within a 64” wide area. Test frame is approximately 26 inches deep and 84 inches tall. _ Ten (10) glove connection/test positions spaced on compact 5-inch (125 mm) centers are provided. Each test support tube is provided with a Velcro and 0-ring manual retention method for the glove cuff. _ Glove connection points to be 60mm (2.375 inch) O.D tubes per ASTM D5151. Each mounting tube will offer ± 90Ί of rotary motion to aid in inspecting the product. _ Scribe lines will be provided on each tube, 44mm (1.5” ) above the open end forlocation/positional guidance. _ System timing and sequencing is accomplished through a PLC. A 3” monochrome operator interface terminal (OIT) is provided to monitor system parameters and change settings. _ One (1) multicolored light will be provided at each of the ten (10) test stations. The light(s) will sequence based upon the elapsed timeafter the water has been released to the station. (Note Timer values for each step are programmable through the O.I.T.) The system will be programmed as follows: Red light will illuminate first between 0 – 100 seconds, flashing green will illuminate from 101 seconds to 110 seconds and green will illuminate from 111 to 130 seconds, alternating red/green will illuminate from 131 to 140 seconds and red will illuminate after 141 seconds. Stations that are not active will flash red. _ Capability through the OIT is provided for activation/de-activation of solenoid valves, which control the flow of fill water from the upper reservoir cells to each of the ten (10) test positions. _ Programmable timers are provided to control the fill sequence allowing for programmable offset between filling positions from 0 – 999 seconds. Timer will be provided via the PLC and may be calibrated/verified with hand held stop watch. Positions that are not active based upon OIT settings for stations enable/disable will be by-passed. _ A proportioning valve for automated fill and temperature regulation of the supply water to the upper reservoir is utilized. Buyer supplied water lines will connect to two (2) standard Ύ” hose fittings – one for cold and one for hot water. _ One (1) five micron filter will be supplied after the proportioning valve to aid in removing debris from Buyer’s water supply and to aid in protecting the control valves. Seller recommends the use of an upstream 20 micron filter to remove coarse debris and extend the life of the on-board filter. _ Temperature of water supply is monitored by a remote temperature-monitoring device. Temperature probe will be a three wire RTD to improve sensor accuracy. _ If the temperature varies from the set point by a programmable offset, an alarm will sound, however testing/filling will continue. _ A water boost pump system will be supplied and located after the proportioning valve to increase the water pressure above the system set point to insure minimum pressure is supplied to the system to aid in performance and to limit control faults. The 110 volt boost pump will be integrated to the control system for the Test Stand, however pressure setting for the pump will be local to the pump unit, which will be mounted on the back lower side of the frame. _ Lower holding tank constructed from white Polyethylene with a 110 volt, single phase, 60 Hz drain pump to remove test water to Buyer supplied drain. _ Two copies of a machine manual will be provided including parts list, mechanical layout/assembly drawings and equipment electrical schematics. _ IQ/OQ documentation will be supplied and utilized to review and inspect the Water Test system prior to shipment. One day in-house testing in vendor's facility inspection and validation should be included in the base price. If additional time is required please specify time and price. Buyer to perform final OQ and PQ testing. Spare Parts Kit: The spare parts package consists of both long lead commercial items that may fail due to wear or use as well as standard wear items, specifically related to the glove attachment area, which the operator interfaces with. The Spare Part Package includes: _ Two sets (10) Velcro retention straps – total 20 _ 100 Silicone O-rings _ One Upper Valve manifold piped for quick replacement _ One Lower Valve manifold piped for quick replacement _ Two Fill Cylinders (1000 ml) _ Four Clear Mounting Tubes _ Two Solenoid Driver Boards _ Two Red/Green LED light _ One Pump Relay & Relay Socket _ One Lot of Fuses _ One 24 VDC Power Supply _ Two RTD Temperature Probes _ Two Flow Switches _ Two Water Valve Solenoid Cables _ One Reservoir Level Switch _ One PLC with preloaded program _ Two PLC replacement batteries _ One OIT with preloaded program _ One Temperature Monitor _ 100 Quarter-turn M8 T-slot Nuts & M8 Bolt & Washers _ 100 Cable Tie T-Slot Clip Polymer Blocks _ 50 T-Slot Clop Blocks with M6 Threaded Hole _ 50 T-Bolt Kit with Nut M-10 Offerors must include a complete copy of the provisions at FAR 52.212-3 Offerors representations and certifications - Commercial Items with its offer. Offerors must also be registered in CCR, they may do so at the VVR web site http://www.ccr.gov 52.203-6 (SEP 2006) Restrictions on Subcontracting Sales to the Government 52.212-1 (JUNE 2008) Instructions to Offerors - Commercial 52.212-2 (JUNE 2008) Evaluation - Commercial Items - (a) The Government will award a contract resulting form this solicitation to the responsible offeror whose offer conforming to the solicitation will be most advantagous cost wise to the Government. 52.212-3 (AUG 2009) Offeror Representations and Certifications - Commercial Items (Offerors must include a completed copy of 52.212-3 with their offer). The full text of this clause can be located at www.arnet.gove/FAR. 52.212-4 (MAR 2009) Contract Terms and Conditions Commercial Items 52.212-5 (JUNE 2008) Contract Terms and Conditions Required Required to Implement Status or Executive Order - Commercial Item. (The following Clauses are applicable to this requirement: 52.222-3, 52.222-19, 52.222-21, 52.222-26, 52.222-37, 52.222-50, 52.225-1, 52.225-3, 52.225-4, 52,225-13, 52.225-30 and 52.232-33 52.215-5 (OCT 1997) Facsimile Quotations 52.204-7 (APR 2008) Central Contractor Registration 52.219-4 (JULY 2005) Notice of Price Evaluation for HubZone Small Business Concerns 52.219-8 (MAY 2004) Utilization of Small Business Concerns
 

Web Link

FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/NCTR/1060420/listing.html)
 

Place of Performance

Address: 19701 Fairchild, Irvine, California, 92612, United States

Zip Code: 92612
 

Record

SN01930121-W 20090829/090828083138-fd98de1704cec36b6b537ff6e9272c02 (fbodaily.com)
 

Source

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

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