SOURCES SOUGHT
66 -- Vacuum/Gravity Steam Sterilizer System
- Notice Date
- 6/22/2009
- Notice Type
- Sources Sought
- 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-09-1059113
- Point of Contact
- Karen R. Petty, Phone: 301-827-8774
- E-Mail Address
-
karen.petty@fda.hhs.gov
(karen.petty@fda.hhs.gov)
- Small Business Set-Aside
- Total Small Business
- Description
- General Information: Document Type: Sources Sought Release Date:June 22, 2009 Response Date: June 29, 2009 at 5:00pm, EST via e-mail to Contract Specialist: Karen Petty at karen.petty@fda.hhs.gov. Contracting Office Address: Food and Drug Administration 5630 Fisher Lane Rockville, Maryland 20857 Description: Vacuum/Gravity Steam Sterilizer system. This is a SOURCES SOUGHT NOTICE to determine the availability and capability of small business (including certified 8(a), Small Disadvantage businesses, HUB Zone businesses; veteran-owned small businesses, and women-owned small businesses. This notice is being posted for fact finding and planning purposes only and shall not be construed as an Invitation for Bid, a Request for Proposal, Solicitation, Request for Quotes, or an indication the Government will contract for the items or services herein. This notice is not to be construed as a commitment on the part of the Government to award a contract, nor does the Government intend to pay for any information submitted as a result of this notice. The Government does not reimburse respondents for any cost associated with submission of the information being requested or reimburse expenses incurred to interested parties for responses to this source sought. Any response received will not be used as a proposal. No official solicitation currently exists in connection to this request for information (RFI). Also, if in the future an official solicitation is released, there is no guarantee that sources responding to this RFI will be included on the source list. **QUESTIONS WILL NOT BE ENTERTAINED AS A RESULT OF THIS NOTICE** The Food and Drug Administration (FDA), Office of Acquisitions and Grants Services (OAGS), Division of Acquisition Operations (DAO) is seeking to obtain a Vacuum/Gravity Steam Sterilizer system. Specifications: A contractor would be required to provide a 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 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 one 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. >> 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 140°C. >> 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 must 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 generator’s operational life, and minimize steam generator related maintenance requirements. >> This purification system must 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. The FDA anticipates using a firm fixed price type contract for these services. The NAICS code is 334516. Part A. Capability and Technical Experience – Interested parties should submit capability statement describing adequate training and experience in scientific and technical appropriateness in reference to providing a Vacuum/Gravity Steam Sterilizer. Part B. Size of Business – Please provide your business size (including certified 8(a), Small Disadvantage businesses, HUB Zone businesses; veteran-owned small businesses, and women-owned small businesses) and submit copies of any documentation such as letters of certifications to indicate the firm status. Part C. Organizational Conflict of Interest (OCI) – If any; provide disclosure of business activities of your company, your affiliates, and your team members and affiliates of your team members which create either a conflict of interest or the appearance of a conflict of interest in the performance of the possible work on evaluation listed above. Part D. Cost Estimate – Please provide a cost estimate for the prospective services to be conducted under the potential to provide a Vacuum/Gravity Steam Sterilizer. Cost should consist of the type of personnel need, hourly rate/days, material and travel expense if applicable or related to the proposed project. Part E. Small Business – Describe your ability to meet the requirements in accordance with 52.219.14 – Limitation of Subcontracting. Responses shall adhere to the following: 1. Reference the Sources Sought number when submitting Capability Statement. 2. The capability statement shall be no more than five (5) pages in length. 3. The marketing materials shall not be included. 4. The capability statement shall be e-mailed to the attention of the Contract Specialist listed above. FDA makes no implied or in fact contract by issuing this Sources Sought. Acknowledgement of receipt of responses will not be made, nor will respondents be notified of the FDA’s view of the information received. Material that requires a non-disclosure agreement or that may be business sensitive will not be accepted. Please note that responses to this notice will not be returned.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/FDA-09-1059113/listing.html)
- Place of Performance
- Address: 19701 Fairchild, Irvine, California, 92612, United States
- Zip Code: 92612
- Zip Code: 92612
- Record
- SN01852191-W 20090624/090622235611-84d45ce5a0a00ee198025d3312cdba5d (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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