SOLICITATION NOTICE
66 -- Sterilizer Units
- Notice Date
- 4/14/2009
- Notice Type
- Modification/Amendment
- 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, Maryland, 20857-0001
- ZIP Code
- 20857-0001
- Solicitation Number
- FDA-SOL-09-1054788
- Archive Date
- 5/1/2009
- Point of Contact
- Tara R. Hobson,, Phone: 3018279691, Doreen Williams ,, Phone: 3018273366
- E-Mail Address
-
Tara.Hobson@fda.hhs.gov, doreen.williams@fda.hhs.gov
- Small Business Set-Aside
- N/A
- Description
- THIS SOLICITATION WILL BE EXTENDED TO APRIL 16, 2009 AT 4:30PM NO MORE QUESTIONS WILL BE ACCEPTED AT THIS TIME. 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 purchase order will include all applicable provisions and clauses in effect through the Federal Acquisition Circular 05-31. This announcement constitutes the only solicitation and a written solicitation will not be issued. The Government intends to award a fixed priced purchase order. The NACIS code for this procurement is 334516, for full and open competition. The Food and Drug Administration (FDA) is located at 5100 Paint Branch Parkway, College Park, MD 20740. We are in need of three, new, sterilizers. Each autoclave/sterilizer unit shall have a single door unit with hinged, fully opening, manual, radial arm door with solid silicone gasket. Sliding doors, and gasket doors, inflated by either steam or air, ARE NOT ACCEPTABLE. Used or Refurbished sterilizers ARE NOT ACCEPTABLE. Line Item 001: (1) Consolidated Model SR-24D-ADVPRO, 24” x 36” x 48" sterilizer Line Item 002: Installation-Removal and disposal of old sterilizer, delivery, installation, set-in place new sterilizer, hook up to disconnects, test and demo to customer Line Item 003: (1)Consolidated Model SR-24D-ADVPRO, 24” x 36” x 48" sterilizer Line Item 004: Installation-Removal and disposal of old sterilizer, delivery, installation, set-in place new sterilizer, hook up to disconnects, test and demo to customer Line Item 005: (1) Consolidated Model SR-24D-ADVPRO, 24” x 36” x 48" sterilizer with the following accessories: Line Item 006: Installation-Removal and disposal of old sterilizer, delivery, installation, set-in place new sterilizer, hook up to disconnects, test and demo to customer Line Item 007: Shipping/Delivery Price Warranty: Warranty must be of the product explicitly stated. CCR: Vendor must be registered in the Central Contractor Register (CCR) prior to the award of the contract. You may register by going to www.ccr.gov. Mandatory Requirements: 1.Units supplied shall conform to the specifications outlined in this document. 2.Units shall be 24”x36”x48 with electric steam generators. 3.Electric steam generators must have automatic water fill and low water cutoff protection 4.Steam generator blow down shall be provided. 5.The vendor, who is awarded the Purchase Order and/or their assigned representative, is required to visit the site to familiarize themselves with 1) access to the building 2) location of the utilities with respect to the installation site and 3) the area in which the unit is to be installed. 6.The successful vendor must provide up to 1 hrs of training at installation site. 7.The vendor who is awarded the bid will be responsible that all final connections coordinate with the existing utility infrastructure that is in place. 8.The vendor who is awarded the bid must insure that their equipment is compatible with the existing utilities. Confirm through a site visit if necessary. 9.The pressure vessel must meet ASME code section VIII, Division 1, standards. 10.Piping and wiring drawings are required by the awarded vendor and must accurately reflect the locations of all items related to the sterilizer. 11. Over and above the 1-year warranty the sterilizer’s chamber and doors shall be warranted for a minimum of 15 years. A copy of the standard warranty that would apply to this vessel and doors must be submitted with the proposal. 12.The sterilizer supplier will be responsible for activation and commissioning of new unit. 13.The sterilizer(s) shall be recessed and must fit in the space. 14.The vessel jacket and reinforcements shall be fabricated of carbon steel. 15.The vessel jacket shall be insulated. 16.The vessel jacket shall provide a pressure relief valve (PRV). The PRV shall be piped in a safe manner that eliminates inadvertent exposure of personnel to a steam release. The PRV shall be set at a value that protects the jacket from over pressure or exceeding the pressure rating of the jacket. The PRV is a critical component and must be manufactured from a reliable vendor and covered by awarded bidder’s warranty. 17.The chamber shall be fabricated of type 316 stainless steel. The chamber shall be polished. All welds must be ground smooth and continuous The interior chamber finish shall be Ra*30 (150 Grit Size) polished. 18.The inner chamber floor shall be furnished with appropriate number of chamber drains (removable strainers included) to facilitate drainage. 19.The sterilizer chamber shall be equipped with baffled steam inlet. The internal steam baffling, made of 316 stainless steel, shall be designed to direct condensate to the chamber floor drain to minimize load wetting by direct impingement on the load by condensate, and help assure proper steam temperature distribution in the chamber. 20.All piping and fittings must be steel piping or better, malleable iron check valves and/or brass. 21.Steam connections to the chamber shall consist of steel piping or better, malleable iron check valves, brass solenoids and fittings. 22.All electrical components must be hardwired. 23.The sterilizer(s) shall be single door type, radial type, made of 316 stainless steel. Provide following minimum autoclave door safety features: Multiple Holding Arms: Door arms designed so that failure of any one arm shall not cause the door to fail. Remaining arms shall take up the load and remain below their tensile limit. Visual Arm to End Frame Engagement: Door engagement shall be clearly visible to the operator allowing for confirmation of closure before beginning any cycle. Operator Chamber Gauge: Complying with ASME code, provide a chamber pressure gauge that is accessible to the operator. Control Lockout Switch: Door limit switch shall inform the control when door is fully closed and locked. Cycles shall not start without this signal. If signal is lost during a cycle, operation shall cease. Total control failure shall leave all mechanical safety features intact. Mechanical Steam Pressure Lock: Radial door pressure clutch assembly shall lock the door post when there is pressure in the chamber. Chamber pressure shall force a membrane against the clutch plate, engaging the lock mechanism. This membrane shall permit tightening, but not loosening of the door if positive pressure exists in the chamber. Venting: When radial door handles are turned to close, the arms shall extend out and into the end frame. Arms shall be designed to fully extend before door seal is compressed. Continuing to rotate door handles shall not cause door arms to further extend, but shall press door against sealing surface to compress seal. Also, pressure shall not be built up unless door is pressed firmly against sealing surface, which shall insure door arms are fully engaged in end frame. 24.Door must have gaskets to insure a tight closure. Steam or air inflated gasket shall not be acceptable. 25.Door gaskets shall be solid silicone and mounted on the door. 26.The sterilizer shall be fitted with adjustable leveling legs. The base of the leveling legs shall provide a flat surface that adjusts to floor pitch. Legs must be capable of fastening to the floor. The adjustable legs must be secured to maintain level. 27.An effluent tempering mechanism is required. 28.Terminals, motor contactors and other relevant electrical control, etc. shall be housed in a cabinet located on the piping frame of the service area. 29.The sterilizer must minimally provide local alarm systems for all aspects of the sterilizer cycle and status. 30.Fascia access panels are required for servicing the sterilizer where appropriate. 31.Bidder must price and bid the most current sterilizer product line offered at the time of the bid and the equipment must be manufactured within 6 months of the award date. 32.The steam sterilizer shall be configured with one standard off-the-shelf Allen-Bradley brand PLC programmable logic control¬ler with full-function 18-bit color touch screen display available with a 6” (15.24cm) or 10” (25.4cm) screen size. a.Color display shall be 6” (15.24cm) screen with a resolu¬tion of 320 x 240 pixels, b.A built-in menu shall be included. c.The controller shall have a multi-layered password access. 33.The controller shall include the following alarm functions: a.Cycle Over Buzzer Count i.When a cycle ends, sterilizer buzzer shall sound for one minute or until the door is opened. The “buzz count” specifies how many times the buzzer will be activated if the door remains closed. A four minute quite period between on minute buzzer activation shall be provided. b.Recycle Alarm i.Alarm when enabled shall cause the buzzer to sound for thirty seconds when the chamber temperature drops below the sterilization temperature setting during the “sterilize” phase of a cycle. Recycle message will always be printed. c.Over Temperature Alarm i.Alarm when enabled, causes buzzer to sound for thirty seconds if temperature in chamber exceeds the sterilizing temperature setting by the over temperature amount. d.Time Limit Alarm i.Alarm when enabled, causes buzzer to sound for thirty sec¬onds if the time to achieve a specific temperature, or pressure, vacuum exceeds the associated temperature, pressure, or vacuum alarm time limits. 34.All equipment and parts must be new and unused. 35.Supplier must visit site to verify delivery path to final placement has necessary clearances to accommodate delivery of all products. 36.Supplier shall provide all necessary labor and materials for delivery and placement into final installation location. 37.Must furnish and install all laboratory equipment with necessary components and accessories required to ensure a complete installation and ready for intended use as specified. 38.Must operate with a minimum of 50 PSI dynamic pressure. 39.Interior chamber must have a track assembly that works in conjunction with the loading cart. 40.Must be UL approved. 41.Must meet AAMI/ANSI8. 42.Temperature ranges for cycles must be between 215 degrees F and 275 degrees F depending on type of cycle. 43.Supplier shall provide one (1) loading cart and carriages with each sterilizer purchased. QUESTIONS DEADLINE: all questions must be received by email (Tara.Hobson@fda.hhs.gov) before April 10, 2009 at 4:30pm EST. RESPONSES to this RFQ are due by email to Tara.Hobson@fda,hhs.gov no later than April 15, 2009 at 4:30pm EST. Delivery of the product will be FOB destination. The contractor shall deliver the product to 5100 Paint Branch Parkway, College Park, MD 20740. Award will be made to the party whose quote offers the best value to the Government, lowest price, technically acceptable. The Government will evaluate information based on the following evaluation criteria: 1) Technical 2) Price. Technical Capability is more important than price. Offerors must meet the mandatory requirements listed above. PROVISIONS and CLAUSES: The provision at FAR 52.212-1, Instructions to Offerors Commercial Items applies to this solicitation. The following agenda has been attached to this provision: None. Offerors shall include a completed copy of the provision at FAR 52.212-3, Offeror Representations and Certifications Commercial Items. The clause at FAR 52.212-4, Contract Terms and Conditions, Commercial Items applies to this acquisition. The following agenda has been attached to the clause: None. The clause at FAR 52.212-5 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 52.204-7, FAR 52.232-33. Clauses and provisions are incorporated by reference and apply to this acquisition.
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