RAPID STERILITY INSTRUMENT

MARKET RESEARCH PURPOSES ONLY

NOT A REQUEST FOR PROPOSAL OR SOLICITATION

The U.S. Food and Drug Administration (FDA), Office of Acquisitions and Grants Services (OAGS) is issuing this source sought announcement on behalf of the Irvine Medical Products Laboratory (IRVLMP), in order to determine if there are existing small business sources capable of providing a Rapid Sterility Instrument. Other than small business concerns, especially vendors who may be able to offer domestic products, are also encouraged to submit a capability statement that provides company information, as well as information demonstrating that it can meet all of the minimum requirements included below, to include the country of manufacture of products offered.

If your firm is considered a small business source under North American Industry Classification System (NAICS) Code 334516 - Analytical Laboratory Instrument Manufacturing; with a Small Business Size Standard of 1,000 employees and you believe that your firm would be able to provide the FDA with the supplies/services described below, please submit an email to Warren.Dutter@fda.hhs.gov.

Background:  

The Food and Drug Administration (FDA), Irvine Medical Products Laboratory (IRVLMP), is an ISO/IEC 17025 accredited regulatory testing laboratory that performs microbiological analyses of medical products to determine compliance with United States Pharmacopeia (USP) requirements and other applicable regulatory standards. Sterility testing conducted by the laboratory plays a critical role in supporting regulatory enforcement actions, compliance determinations, and public health protection.

Traditional sterility testing under USP <71> requires extended incubation periods, which may delay final results. In high-priority or time-sensitive situations, delays in sterility determinations can impact the FDA’s ability to take timely regulatory or public health action.

To enhance responsiveness in critical cases, IRVLMP requires a Rapid Sterility Instrument capable of reducing incubation time and providing faster sterility results compared to conventional USP <71> methods. The system will support accelerated detection of microbial contamination while maintaining compatibility with compendial testing workflows and regulatory standards. The objective is to obtain reliable sterility results more quickly to enable informed, timely decisions that protect public health.

Minimum Technical Requirements:

1. The instrument shall utilize ATP-bioluminescence technology for microbial detection.
2.  The instrument shall be compatible with USP <71> compendial media, specifically Soybean-Casein Digest broth media and Fluid Thioglycollate broth media.
3. The instrument shall be capable of analyzing both filterable and non-filterable pharmaceutical products.
4. The instrument shall be compatible with both direct inoculation and membrane filtration procedures found in USP <71>.
5. The instrument shall be compatible with a closed canister filtration testing process.
6. The instrument preparation protocol must preserve the original pharmaceutical product preparation to allow for additional incubation, subculturing and identification of isolates.
7. Instrument protocols for sterility testing of pharmaceutical products shall provide results in 7 days or less.
8. The instrument shall have a testing capacity of at least 28 tests per hour.
9. The process of reagent additions and reading of results shall be automated and handled by the instrument.
10. Software to control the instrument and obtain results shall be provided and must be compliant with 21 CFR Part 11.
11. Instrument shall be a benchtop model with a footprint that shall be no larger than 24 inches x 24 inches x 24 inches (WxDxH). Instruments with dimensions exceeding this footprint will require review for bench space availability; otherwise may be determined to be unacceptable).
12. Electrical requirement must be compatible with a standard US outlet, 100-240V, 50 or 60 Hz.

Installation, Training and Additional System Requirements:

1. The components and equipment shall be newly manufactured, not used or refurbished, or previously used for demonstration.
2. Offered systems shall be a turn-key solution i.e., the contractor shall be responsible for providing all hardware, components, instruments, computers, software, and that otherwise required to meet these specifications and the FDA’s stated need.
3. The systems shall be delivered with all necessary supplies and accessories required for installation and start-up.
4. The system and associated accessories shall include operations and maintenance manuals covering proper operation, routine maintenance, and troubleshooting for the system and controlling software.  All manuals and documentation shall be provided in hard copy and/or electronic format.
5. The Contractor shall provide all labor, travel, and tools to install the equipment at the address provided below, to include shipping. The contractor shall demonstrate upon installation that the item meets or exceeds all performance specifications, to include verification testing. Upon acceptance of the system, the contractor shall provide on-site operator training/familiarization for two (2) users. Such familiarization shall include system operations, calibration, optimization, troubleshooting and basic operational maintenance procedures.    
6. Systems shall be warranted for not less than one (1) year from FDA acceptance of the system(s). Warranty service shall include troubleshooting capabilities based on complete knowledge of the entire system, immediate access to replacement parts. Phone and email technical support shall be included for a minimum of one (1) year. 

Place of Performance:

FOB Point Destination. All items shall include shipping, handling, installation, and inside delivery to the destination identified herein.

FDA/IRVLMP

19701 Fairchild

Irvine, CA  92612

Period of Performance:

Delivery, installation and training shall occur within 90 calendar days from date of award.

Responses to this Sources Sought shall unequivocally demonstrate that the respondent is regularly engaged in the sale of same or substantially similar product/service.  Though the target audience is small business vendors or small businesses capable of supplying a U.S. service of a small business vendor or producer all interested parties may respond. At a minimum, responses shall include the following:

• Business name and bio, unique entity identification (UEI) number, business address, business website, business size status (i.e., SB, VOSB, SDVOSB, HUBZone SB, SDB, WOSB, LB), point of contact name, mailing address (if different from business address), phone number and email address. Provide this same information again if responding to provide a service offered by another firm.

• Past Performance information for the manufacturer and/or sale of same or substantially similar product and service or similar brand instruments to include date of sale, description, dollar value, client name, client address, client 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 UEI number and size status) if not the respondent.

• Descriptive literature, brochures, marketing material, etc. detailing the nature of the product and service the responding firm is regularly engaged in manufacturing and/or selling.

• The offeror shall furnish sufficient technical information necessary for the Government to conclusively determine that the offered items/services meet the technical requirements identified above.

• If applicable, identification of Best in Class (BIC) contract information or other Government-wide or HHS-wide contracts that the equipment/service is available on.

• If applicable, identification of the firm's GSA Schedule contract(s) by Schedule number and SINs that are applicable to this potential requirement are also requested.

• If a large business, provide whether subcontracting opportunities exist for small business concerns.

• Standard commercial warranty and payment terms.

• Provide place of product manufacture or service performance and any other applicable information to enable review and analysis pertaining to the Buy American statute and requirements relating to Made in America in the event a nonavailability waiver request through the MIAO Digital Waiver Portal is needed.

• Informational pricing is desired.

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

Interested Contractors must respond with capability statements which are due by email to the point of contact listed below on or before March 10, 2026, by 1:00 PM Central Time at the Food and Drug Administration, Field Operations Branch, FDA|OO|OFBA|OAGS|DAP, Attn: Warren Dutter, email warren.dutter@fda.hhs.gov. Reference: FDA-SSN- 132933.

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.

Responses with weblinks will not be opened or viewed.

Responses must demonstrate capability, not merely affirm the respondent's capability (i.e. the response must go beyond the statement that, "XYZ company can provide the instrument, technical support etc.").

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 pre‐solicitation synopsis and solicitation may be published in sam.gov. However, responses to this notice will not be considered adequate responses to a solicitation.

Confidentiality and Proprietary Information:

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).

Additional Notes:

If the stated requirements appear restrictive, please submit comments detailing the concern. Failure to provide information indicating that the listed specifications are too restrictive will be interpreted as confirmation that the specifications are adequate for a competitive environment.

This is a sources sought announcement, a market survey for written information only. This is not a solicitation announcement for proposals and no contract will be awarded from this announcement. No reimbursement will be made for any costs associated with providing information in response to this announcement or any follow-up information requests. No telephone calls will be accepted requesting an RFQ package or solicitation. There is no RFQ package or solicitation. In order to protect the procurement integrity of any future procurement, if any, that may arise from this announcement, information regarding the technical point of contact will not be given.