Vaporized Hydrogen Peroxide Bio Decontamination Sterilization System

MARKET RESEARCH PURPOSES ONLY
NOT A REQUEST FOR PROPOSAL OR SOLICITATION

This is a sources sought to determine the availability and capability of small businesses in providing a Vaporized Hydrogen Peroxide Bio Decontamination Sterilization System. The associated North American Industry Classification System (NAICS) Code is 334516- Analytical Laboratory Instrument Manufacturing; Small Business Size Standard is 500 employees.

Part I: General Information (Introduction/Background/Scope)

The U.S. Food and Drug Administration (FDA), National Center for Toxicological Research (NCTR), offices of Microbiology Surveillance and Research Animal Diagnostic and Investigative Laboratory (Micro RADIL), within the Office of Scientific Coordination, conduct basic and applied research to support regulatory decision-making recommendations. This microbiology research involves the isolation, identification, and characterization of microorganisms potentially harmful to animals and humans and includes monitoring and evaluation of the sanitation levels of animal rooms, caging, equipment, and cage washing facilities. The microbiological monitoring of the test animals helps maintain the integrity of the research program by guarding against both primary and opportunistic pathogens that may interfere with research results.
Formerly, Micro RADIL used a sterilization system with an ethylene-oxide base unit. Ethylene-oxide is a highly toxic gas that is flammable, carcinogenic, and can cause damage to multiple organs (kidneys, lungs, the reproductive system, liver, upper respiratory tract, skin, eyes, and central nervous system). To ensure operator and environmental safety, the new system shall operate with low temperatures and dry, Vaporized Hydrogen Peroxide (VHP) methods. Hydrogen peroxide is a non-flammable, colorless, odorless liquid and is listed as GRAS (Generally Regarded as Safe). Dry VHP is produced by vaporization of 35% liquid hydrogen peroxide and maintaining the vapor concentration below the dew point throughout the sterilization cycle. VHP rapidly degrades in the environment to water vapor and oxygen; non-toxic innocuous byproducts.
Scope
The contractor shall provide a Vaporized Hydrogen Peroxide Bio Decontamination Sterilization System inclusive of inside delivery, installation, training, and up to four (4) option years of post-warranty preventive and corrective maintenance.

Part II: Technical Requirements

A. Vaporized Hydrogen Peroxide Bio Decontamination Sterilization System

At a minimum the contractor shall provide:
•VHP Low Temperature Sterilization System/Bio Decontamination Unit
•System that controls the VHP vapor concentration below the dew point throughout the sterilization cycle; thus providing dry sterilization
•Operator protection mechanisms to limit operator exposure to the liquid hydrogen peroxide
•Dispensing or transferring of the hydrogen peroxide draws directly from the bottle to the sterilization system to ensure operator safety
•Small footprint, countertop or cart size, due to limited laboratory space
•Minimum of three sterilization cycles, Lumen, Non-Lumen, and Flexible
•Minimum 60L volume
•Plasma-free processing
•Exhaust free system
•Equipment operation manuals; electronic format acceptable
•Maximum 15 Amp/115V/60/60Hz
•Turn-key solution which shall include, but not be limited to: all hardware, software, components, connectors, interfaces, instruments, kits, etc. required to meet these specifications and the FDA's stated need and intended use for the system.

B. Inside delivery, Installation Training

At a minimum the contractor shall provide:

•Inside delivery, installation, and clean-up of installation system with on-site training for up to five (5) system operators, including but not limited to system operations, quality control, instrument programming, basic and routine preventative maintenance procedures, and troubleshooting techniques.

C. Service Agreement
At a minimum the contractor will be required to provide:

I. Warranty
•Minimum 12-month warranty on the entire system inclusive of parts, labor, and travel expense to commence upon completion and acceptance of system and training.
•Warranty work shall guarantee operation of the equipment to FDA stated intended use in accordance with OEM specifications.

II. Post-Warranty System Service Plan: Preventive Maintenance/Corrective Maintenance Service
•One (1) scheduled preventive maintenance visit per contract year inclusive of parts, travel, and labor expense
•Unlimited corrective/remedial maintenance visits within 3 business days of call for service inclusive of parts, travel, and labor expense
•Unlimited technical support, Mondays - Fridays (excluding Federal Holidays) between the hours of 8:00 AM - 5:00 PM Central Time, within 8 business hours of contact for assistance (e.g., telephone-based, email-based, website-based, etc.)
•All maintenance and repair activities performed by trained and certified technicians/engineers, following Original Equipment Manufacturer (OEM) specifications, manuals, and service bulletins, using OEM replacement parts, components, subassemblies, etc.
•Access for the FDA Technical Point of Contact (TPOC) and system operator personnel to the manufacturer's call center for technical assistance, which is staffed by senior engineers to provide a high level of expertise for troubleshooting the instrument

Part III: Supporting Information

A.Place of Performance
System in-side delivery, installation, and training shall occur at:

U.S. Food and Drug Administration
National Center for Toxicological Research
3900 NCTR Road
Jefferson, AR 72079

B. Period of Performance
System in-side delivery, installation, and training shall occur within 60 calendar days (or less) from receipt of contract award.

Part IV: Instructions to Prospective Respondents

The offeror shall furnish sufficient information necessary for the Government to conclusively determine that the respondent is capable and otherwise qualified to provide the equipment, warranty, and post-warranty services identified herein. At a minimum, responses shall include the following:

•Business name and bio, DUNS number, business address, business website, business size status (i.e., SB, VOSB, SDVOSB, HUBZone SB, 8(a), SDB, WOSB, EDWOSB, LB), point of contact name, mailing address (if different from business address), phone number and email address;

Past performance information for the same or substantially equipment, warranty, and post-warranty services, description of work (should also include technical literature and specifications), dollar value, client name, client address, client point of contact name, client point of contact mailing address (if different from that provided for client), client point of contact phone number, client point of contact email address, and name of the manufacturer (to include DUNS number and size status) if not the respondent;

Descriptive literature, brochures, specifications, marketing material, etc. detailing the nature of the equipment and/or services the responding firm is regularly engaged in providing;

If applicable, identification of the firm's GSA Schedule contract(s) by Schedule number and SINs that are applicable to this requirement;

Although this is not a request for quote, informational pricing is encouraged;

The Government encourages any comments and/or suggestions from any interested party, regarding the specifications. While the Government will not respond directly to your comments and/or suggestions; we will consider them as we finalize the specifications in preparation for the forthcoming solicitation.

The Government is not responsible for locating or securing any information, not identified in the response.

Interested parties must respond with capability statements, which are due in person, by postal mail or email to the point of contact listed below on or before August 11, 2015 by 9:00 AM (Central Time in Jefferson, Arkansas) at the Food and Drug Administration, OO|OFBA|OAGS|DAP, Attn: Sondea Blair, 3900 NCTR Road, Bldg 50/Room 421, HFT‐320, Jefferson, AR 72079‐9502 or email sondea.blair@fda.hhs.gov. Reference Number 1152366 in all correspondence with the point of contact listed above.

Notice of Intent
Responses to this sources sought announcement will assist the Government in determining whether this requirement should be set aside for small business, made available to full and open competition or procured through other than full and open acquisition procedures.

Disclaimer and Important Notes
This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a combined synopsis/solicitation (No. FDA-15-223-SOL-1152366) may be published via FedBizOpps. However, responses to this notice will not be considered adequate responses to a solicitation.

Confidentiality
No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).