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66 -- Vacuum/Gravity Steam Sterilizer System

Notice Date
Notice Type
Combined Synopsis/Solicitation
339113 — Surgical Appliance and Supplies 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
Solicitation Number
Point of Contact
Karen R. Petty, Phone: 301-827-8774
E-Mail Address
Small Business Set-Aside
Total Small Business
This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in FAR 12.6. This announcement constitutes the only solicitation and a written solicitation will not be issued. This synopsis, NAICS code 339113, is to notify contractors that the Food and Drug Administration (FDA) is seeking competition of this requirement in accordance with FAR Part 13.106 for the following statement of work, under the simplified acquisition procures. Under the simplified acquisition procedures and the resultant purchase order will include all applicable provisions and clauses in effect through the Federal Acquisition Circular 05-32. This synopsis is designated for 100% Small Business Set Aside competition for a firm fixed-price purchase order. Prospective offerors are responsible for monitoring the FedBizOpps website for the release of any amendments to this solicitation. Hard copies will be provided to individuals eligible under the Americans with Disabilities Act and Rehabilitation Act upon request. The Government reserves the right to award a contract without discussions if the Contracting Officer determines that the initial offer(s) is/are providing the Best Value and discussions are not necessary. This combined synopsis solicitation is issued as a Request for Quotations (RFQ). The FDA intends to award a purchase order for a Vacuum/Gravity Steam Sterilizer System. 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-porous 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, Division 1), the Uniform Plumbing Code, and California building 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. >> Shall be micro-computer controlled with both built-in color computer screen display and printer for displaying and 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, etc.). Must include the ability to display real time 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. >> Shall include easily accessible, selectable, pre-programmed and password protected sterilization cycles (a minimum of 15) to include a combination of preset vacuum, gravity and liquid cycles, and a vacuum leak test cycle. Each factory installed cycle must be validated against ANSI/AAMI ST8, and the user must be able to adjust cycle parameters (i.e., time, temperature) in response to local requirements. >> Selectable cycle temperatures shall range from 230F to 275F for solids cycles and 219F to 275F for liquid cycles with temperature selectivity in 0.1F (or 0.1C) increments. >> Cycle Timing functions shall be selectable in one-second increments and be accurate to plus/minus one percent. >> Cycle run functions shall 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. >> Shall include serial communication capabilities (i.e., an RS-232 port) that will allow for central data backup/storage/collection (i.e., by a LIMS), and remote service support/analysis by a vendor. >> Shall include discharge water control system (i.e., a blow-down unit) that limits discharge water temperature to less than 140C. >> Shall 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: >> Shall 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 shall 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 shall have at least two levels with the upper level adjustable and removable. The transfer carriage shall also easily slide between the loading car and the sterilizer chamber Steam Generator & Feed Water Pump: >> Shall 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 shall interface seamlessly with the sterilizer and include an automated blow-down feature for boiler maintenance. Water Purification System: >> Shall 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 generators operational life, and minimize steam generator related maintenance requirements. >> This purification system shall interface seamlessly with the steam generator. (NOTE The above components (sterilizer, loading cart and carriage, steam generator and water purification system) must be purchased as an integrated unit in order for the system to function seamlessly.) Installation: >> At least one pre-install walk through by the installation team to review site to verify that required facility related requirements (plumbing, electrical, structural, etc.) are in place. >> Shall include uncrating and moving of equipment from contiguous on-site location to point of installation, and leveling and hanging equipment as necessary. >> Shall include connecting to existing utilities (electrical, water & waste) and final operational/functional check-out. >> Shall include seismic anchoring. >> Shall include removal of associated debris to customer provided receptacles. >> Shall include at least two post install return visits for adjustments as necessary during the warranty period. Warranties: >> Shall include preventive maintenance inspections and parts replacement required during the warranty period. EVALUATION AND AWARD: Award will be made to the party whose quote offers the best value to the Government, technical, price, and other factors considered. The Government may award this purchase order to other than the lowest price technically acceptable quote. The Government will evaluate information based on the following evaluation criteria: 1) Technical Capability factor "Meeting or Exceeding the Requirement," and 2) Price-- price warranty to include four (4) option years. Technical Capability is significantly more important than price. The FDA intends to make an award immediately after the response date of this notice. The award will be made in accordance with FAR Part 13, Simplified Acquisition Procedures. Place of Performance: Food and Drug Administration 19701 Fairchild Irvine, CA 92612 CCR: Vendors must be registered in the Central Contractor Register (CCR) prior to the award of a contract. You may register by going to www.ccr.gov. You will need your Dun & Bradstreet number and banking information. All responsible sources that can provide and meet the above requirements, shall submit written quotation by the response date. QUESTIONS DUE: All questions must be received by email to: karen.petty@fda.hhs.gov, no later than 5:00pm, EST on or before Monday, July 20, 2009. QUOTATIONS DUE: All quotations must be received by email to: karen.petty@fda.hhs.gov, no later than 5:00pm, EST on or before, Thursday, July 23, 2009. Telephone calls will not be accepted. 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 52.217-8, FAR 52.222-26, FAR 52.222-35, FAR 52.222-36, and FAR 52.232-33. Clauses and provisions are incorporated by reference and apply to this acquisition.
Web Link
FBO.gov Permalink
Place of Performance
Address: 19701 Fairchild, Irvine, California, 92612, United States
Zip Code: 92612
SN01876186-W 20090717/090716000009-503890da35e71e05aeed9c0475224c0e (fbodaily.com)
FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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