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66 -- Vacuum/Gravity, Microcomputer-Controlled Steam Sterilizer

Notice Date
Notice Type
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, UNITED STATES
ZIP Code
Solicitation Number
Response Due
Archive Date
Point of Contact
London Johnson, Contract Specialist , Phone 301-827-7041, Fax 301-827-7039, - London Johnson, Contract Specialist , Phone 301-827-7041, Fax 301-827-7039,
E-Mail Address
London.Johnson@fda.hhs.gov, London.Johnson@fda.hhs.gov
****Amendment 01 is to add the Model number for the Vacuum Gravity microcomputer-controlled Steam Sterilizer. The Model number is Model 533LS. All questions about this solicitation should be in writing and sent to London.Johnson@fda.hhs.gov***** The United States Food and Drug Administration?s Center for Biologics Evaluation and Research (CBER)/Division of Product Quality in the Office of Vaccines Research and Review is seeking offers for a vacuum/gravity, microcomputer-controlled steam sterilizer. The procurement should be delivered as a unit. This is a combined synopsis/solicitation for commercial items (as defined by FAR 2.101) prepared in accordance with the format in Federal Acquisition Regulation (FAR) Subpart 12.6, as supplemented with additional information in this notice. This announcement constitutes the only solicitation. A written request for quotations will not be issued. This acquisition is subject to FAR Subpart 13.5 regarding the application of simplified acquisition procedures. This acquisition is issued as Request for Quotation (RFQ) FDA-SOL-07-00338. All responsible business sources may submit an offer that will be considered. The NAICS code is 334516. The small business size standard is 500 employees. This is NOT a small business set-aside. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2005-18. Offers in response to this RFQ shall be submitted by 3:00 p.m. EDT, August 13, 2007. Quotes and questions shall be submitted via electronic mail to: Mrs. London Johnson. The email address is London.Johnson@fda.hhs.gov. This is an unrestricted solicitation. Offerors shall bid on ALL or NONE of the items identified in this solicitation. The following information contains notations regarding special features of this unit. A) TECHNICAL REQUIREMENTS: the chamber inside, which should be a measurement of 21" x 21" x 38" is required to accommodate trays of vials for reagent preparation. This unit must have multiple pre-programmed cycles and vertical sliding door to accommodate space limitations in the Reagent Preparation area. The unit must be equipped to perform cycles that include gravity, vacuum, liquid cycles and a Vacuum Leak Test cycle. The unit must have operating displays that are easily understood and visible in the controlled environmental area. Programmed cycle settings are protected with only authorized supervisors having access control. The size is critical at this time, as a limited amount of space in new construction has been allocated for the unit; the unit must have a vertical sliding door that minimizes space requirements for the door swing in a controlled environmental area. This unit shall be microprocessor-controlled, automatic steam sterilizer designed to sterilize heat and moisture-stabile laboratory, research and animal care supplies using gravity or downward displacement with positive pulsing conditioning for dynamic air removal, and sterilize liquids in self-venting or unsealed containers using controlled exhaust for linear and consistent cool down. The temperature range is selectable from 110C to 135C (230F to 275F), for liquid cycles from 104C to 135C(219F to 275F.) which is necessary to sterilize many types of packaged goods such as vials, stoppers and instruments. Construction of this unit is of 316Ti stainless steel sectional U channels (jacket) welded around the 316Ti stainless steel inner chamber vessel. The vessel can withstand working pressure of 45 psig and full vacuum. Welded construction complies with ASME Code Section VIII division 1, U1 stamped vessel to allow installation into renovated area. A stainless steel frame will rigidly support the pressure chamber and allow for some variance in height as the unit has adjustable feet; this will be a distinct advantage in the incorporation of the unit into the construction. The unit is equipped with a safety valve (ASME approved and so stamped) for pressure vessel which is set at the approved maximum operating pressure of the vessel. The valve is sealed so that setting cannot be altered, and will blow down at least 2 psig before closing. The valve is sized so that pressure in vessel will not rise more than 10 percent over the set pressure. This unit as described is equipped with a Cross Contamination Barrier (CCB) designed to maintain air differential between the controlled environment where vials are prepared and the outside service areas. A steel flange will be fully welded to load side of the sterilizer. The manufacturer of the unit supplies stainless steel sheet metal paneling to span distance from flange plate to wall opening and seals the flange plate/wall junction with silicone caulking compound, creating the required barrier separation. The unit is also equipped with a safety and cross contamination door interlock to prevent the door from opening until successful completion of cycle. This unit is equipped with a vertical sliding Manual Door with the following properties to conserve space in the controlled environment where the vials are packaged. Additionally, the door is constructed of 316Ti Stainless Steel plate and reinforced to withstand pressure and vacuum without deflection or leakage. A silicon rubber O ring gasket is self compensating and housed in a 316Ti stainless steel channel as part of chamber end ring. Gasket shall be easily replaced without the use of tools. The vertical sliding door is counterbalanced for ease of operation. When open, it is totally out of the way, allowing safe and complete access to the chamber with the trays of vials. Opening or closing the manual door requires only gentle upward or downward hand pressure. The installer insures that the exterior of the sterilizers and door(s) shall be covered with a minimum of 1.5" fiberglass insulation. Sterilizer is equipped with one standard chamber instrumentation port so in-house validation can be performed as needed. This port is provided to facilitate insertion of test equipment and instrumentation leads. Microcomputer controls are PACS 3000 with cycles preprogrammed specifically designed for clean room facilities. Controls are fabricated using state-of-the-art PLC technology. The PACS 3000 controller incorporates F sub 0 functions as part of the software base and utilizes connected printed circuit boards (Control and Printer). The control side is provided with OP30 operating panels; the display is a 5.7 inch diagonal color screen. Control panel(s) with touch pads and digital printer are located above the chamber. Program control is subject to Cycle Backup so that, in case of a power failure, the back-up system holds cycle in phase for up to 1 minute until power is restored from Generators at the NLRC facility. When power returns, event is recorded on printout and cycle resumes or restarts, depending on what phase cycle was in at time of power failure. The program microcomputer monitors and controls all phases of separate steam sterilizing cycles. Temperature display on the printer and and printout units may be recorded or observed either degrees F or degrees C; pressure display in psig/in Hg or Bars, and time either standard AM/PM or Military format. In the laboratory mode of operation, sterilize temperature overdrive, over-temperature point, under-temperature point and chamber pressure points can be set by the operator. The printer must be capable of providing a duplicate print switch to furnish a duplicate printout of entire cycle data (when unit is not in cycle) or of current cycle status (during a cycle). For validation purposes, the printout must have the with date, cycle count, daily cycle number, starting time of each cycle, sterilize temperature selected, sterilize and dry time selected, key transition points in the cycle, and any deviations which may jeopardize sterilization process. Piping used must be copper and brass threaded with standard National Pipe Thread and sealed with pipe sealant prior to tightening. Piping, fittings and connections required to connect the sterilizer to building supply lines are by others. B) INSTALLATION REQUIREMENTS: The installer shall provide the following with the unit: 1) Wall trim panels 2) Boiler Control and Safety Device (CSD-1). Satisfies state ASME requirements for secondary low water cut-off as required by local jurisdiction.), 3) 304 Stainless Steel piping for clean steam Tissue Culture applications. (Required house steam to jacket) 4) Thermocouple Gland, 5) Load RTD for temperature control of a liquid load, 6) Vacuum Pump (533LS w/ house steam only), and 7) Automatic Steam Boiler Blowdown C) UTILITY REQUIREMENTS: 1) Plant Steam Supply: 3/4 inch (19) NPT, 40-50 psig, 96 lbs/hr, 2) Cold Water: 3/4 inch (19) NPT, 30-60 psig, 6 gpm, 3) Compressed Air: 1/4inch(7) NPT, 70-100 psig dynamic, 1 SCFM, 4) Drain:1/2 inch (38) ODT, 5) Electric:1/2 inch (13), 115V, 50/60 Hz, and 6) Hot Water:1/2 inch (13) NPT, 20-50 psig (min.), 0.4 gpm. The unit shall carry a one (1) year warranty for parts and labor and the ASME pressure vessel will carry a fifteen (15) year warranty for workmanship or structural failure. D) LINE ITEMS AND COST REQUIREMENTS: 1) INSTALLATION, 2) PREVENTIVE MAINTENANCE PLAN, 3) TOTAL CARE PLAN, 4) STEAM FILTER PACKAGE, 5) VACUUM GRAVITY MICROCOMPUTER-CONTROLLED STEAM STERILIZER. The cost of the unit shall include all line items solicited as well as documentation packages that address all Installation Qualification Documentation and Operational Qualification Documentation & records to record the execution of such procedures. E) TERMS AND CONDITIONS: The Provisions of FAR 52.212-1 Instructions to Offerors- Commerical Items (Sept 2006), FAR 52.212-4 Contract Terms and Conditions-Commerical Items- (Feb 2007) are hereby incorporated by reference. FAR 52-212-3 Offeror Representations and Certifications- Commercial Items (Nov 2006) ?offerors shall complete only paragraph (k) of this provision if the offeror has completed the annual representations and certifications electronically at http://orca.bpn.gov. If an offeror has not completed the annual representations and certifications electronically at the ORCA website, the offeror shall complete only paragraphs (b) through (j) of this provision. FAR 52.212-5 Contract Terms and Conditions Required to Implement Statutes or Executive Orders-Commercial Items (June 2007), applies as follows: (a)(1) and (a)(2); (b)(15)(16)(17)(18)(20)(24)(25)(ii)(27) and (32). FAR provisions and clauses can be found at www.arnet.gov
Place of Performance
Address: United States Food and Drug Administration, Center for Biologic Evaluation and Research, NLRC RMD 174 HFM-407, 5516 Nicholson Lane, Kensington, Maryland
Zip Code: 20895
SN01358567-W 20070803/070801220642 (fbodaily.com)
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