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FBO DAILY ISSUE OF AUGUST 15, 2010 FBO #3186
SOLICITATION NOTICE

66 -- STEAM STERILIZER/STEAM GENERATOR SYSTEM

Notice Date
8/13/2010
 
Notice Type
Combined Synopsis/Solicitation
 
NAICS
339113 — Surgical Appliance and Supplies Manufacturing
 
Contracting Office
Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services, NCTR-50 RM422 HFT-320, Jefferson, Arkansas, 72079, United States
 
ZIP Code
72079
 
Solicitation Number
FDA-10-223-SOL-00302
 
Archive Date
9/1/2010
 
Point of Contact
Roy E. Mutch, Phone: 404-253-1258
 
E-Mail Address
roy.mutch@fda.hhs.gov
(roy.mutch@fda.hhs.gov)
 
Small Business Set-Aside
Total Small Business
 
Description
The Food and Drug Administration intends to award a Purchase Order for a Steam Sterilizer/Generator System. This is a 100% Set-Aside for a Small Business. The requirements will be awarded using Simplified Acquisition Procedures in accordance with FAR 13.5. This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in FAR 12.6, as supplemented with additional information included in this notice. This announcement constitutes the solicitation: Proposals are being requested and a written solicitation will not be issued. The solicitation number is FDA-10-223-SOL-00302. This solicitation is issued as Request for Quote (RFQ). The associated North American Industry Classification System (NAICS) is 339113. Contract Type: Commercial Item-Firm Fixed Price. All responsible sources may submit a quote which shall be considered. The Food and Drug Administration is soliciting the following: 1. SR-24F-ADVPRO Steam Sterilizer/Generator System, 24'x36"x72" - 1 each REQUIREMENTS: Vacuum/Gravity Steam Sterilizer System for Steam Sterilization and decontamination of laboratory materials for life sciences applications, i.e., wrapped and unwrapped and porous and non-porosus hard goods, textiles and linens, and liquids in self-venting or unsealed containers. Instrument components must comply with the ASME Code for Pressure Vessels (Section VIII, Civision 1), the Uniform Plumbing Code, and California buliding code requirements for Seismic Anchoring. STEAM STERILIZER: Cabinet model (not recessed) with single door hinged on the left. The interior sterilization chamber must be at least 26 inches wide, at least 35 inches high, and have a minimum chamber volume of 33 cubic feet. The chamber finish must be polished and must include a threaded opening that can be used to permit the passage of thermocouple leads to monitor interior and load temperatures. Must be micro-computer controlled with both built-in color computer sereen display and printer for displaying snd reporting run information (sterilizer identification, run cycle, run number, run start time and date) and adjustable cycle parameters (run duration, phase transition points and associated temperatures, pressures and times, verification of time at min/max temperatures, pressures and times, verification of time at run information, include audible alarms that provide notification of deviations from specified operating parameters, and include a screen saver function that will maximize the life of the screen. Selectable cycle temperatures shall range from 230* F to 275* F for solids cycles and 219* F to 275* F for liquid cycles with temperature selectivity in 0.1* F (or 0.1* C) increments. Cycle timing functions must be selectable in one-second increments and be accurate to plus/minus on percent. Cycle run functions must include automated sterilizer startup and shut down capabilities that allow the user to schedule/program cycle start-ups at least 72 hours in advance, i.e., schedule a cycle startup in the afternoon to begin early the next morning or late on a Friday for pre-work hours Monday morning. Must include serial communication capabilities that will allow for central data backup/storage/collection (i.e., by a LIMS), and remote service support/analysis by a vendor. Must include a battery back-up system capable of holding/maintaining stored program cycle data in the event of a power failure. STAINLESS STEEL LOADING CAR AND CARRIAGE: Must include a stainless steel loading car and transfer carriage that will provide for ergonomic and efficient loading and unloading of the sterilization chamber. The load car must be able to accommodate up to 525 lbs of materials, and include instrument interface and wheel locks to hold the cart/carriage in place during carriage transfers and loading/unloading. The transfer carriage must have at least two leverls with the upper level adjustable and removable. The transfer carriage must also easily slide beween the loading car and the sterilizer chamber. STEAM GENERATOR AND FEED WATER PUMP: Must include a integrated steam generation system (no house steam available) that provides the sterilizer with the proper quality and quantity of steam required at tha proper temperatures and pressures for it operate effectively and efficiently. The transfer carriage must have at least two levels with the upper level adjustable and removable. The transfer carriage must also easily slide between the loading car and the sterilizer chamber. STEAM GENERATOR AND FEED WATER PUMP: Must include an integrated steam generation system (no house steam available) that provides the sterilizer with the proper quality and quantity of steam required at the proper temperatures and pressures for it to operate effectively and efficiently. This steam system must interface seamlessly with the sterilizer and include an automated blow-down feature for boiler maintenance. WATER PURIFICATION SYSTEM: Must include an integrated water purification system that feeds the steam generator with the proper quality and quantity of water needed to produce the volumes of steam required for the sterilizer to function at full capacity, extend the steam generator's operational life, and minmize steam generator related maintenance requirements. This purification system must interace seamlessly with the steam generator. (Note - The above components (sterilizer, loading cart and cariage, steam gererator and water purification system) must be purchased as an integrated unit in order for the system to function seamlessly) INSTALLATION AND TRAINING: At least one pre-install walk through by the installation team to review site to verify the required facility related requirements (plumbing, electrical, structural, etc..) are in place. Must include uncrating and moving of equipment from contiguous on-site location to point of installation, and leveling and hanging equipment as necessary. Must include connecting to existing utilities (electrical, water and waste) and final operational/functional check-out. Must include seismic anchoring. Must include removal of associated debris to customer provided receptacles. Must include at least two post install return visits for adjustments as necessary during the warranty period. Must include on-site training. WARRANTY: Must include a minimum of one year service warranty that covers travel, parts and labjor. Must include preventative maintenamce inspections and parts replacement required during the warranty period
 
Web Link
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/NCTR/FDA-10-223-SOL-00302/listing.html)
 
Place of Performance
Address: FDA, TED DUNN, 19701 FAIRCHILD, IRVINE, California, 92612, United States
Zip Code: 92612
 
Record
SN02240008-W 20100815/100813235450-59a4e665b19f82206d070a250e67193d (fbodaily.com)
 
Source
FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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