Rapid Sterility Instrument
Overview
Buyer
Place of Performance
NAICS
PSC
Set Aside
Original Source
Timeline
Qualification Details
Fit reasons
- NAICS alignment with historical contract wins in similar service areas.
- Scope strongly matches core technical capabilities and delivery model.
Risks
- Past performance thresholds may require one additional teaming partner.
- Potential clarification needed on staffing minimums before bid/no-bid.
Next steps
Validate eligibility requirements, assign capture owner, and schedule partner outreach to confirm teaming strategy before submission planning.
Quick Summary
The U.S. Food and Drug Administration (FDA), specifically the Irvine Medical Products Laboratory (IRVLMP), is conducting market research through a Sources Sought notice to identify small and other businesses capable of providing a Rapid Sterility Instrument. This instrument is needed to reduce incubation times for sterility testing, enabling faster results for critical public health decisions. Capability statements are due by March 10, 2026.
Scope of Work
The FDA requires a Rapid Sterility Instrument that utilizes ATP-bioluminescence technology for microbial detection. Key technical requirements include compatibility with USP <71> compendial media (Soybean-Casein Digest broth, Fluid Thioglycollate broth), ability to analyze both filterable and non-filterable pharmaceutical products, and compatibility with direct inoculation and membrane filtration procedures. The instrument must provide results in 7 days or less, have a testing capacity of at least 28 tests per hour, and feature automated reagent additions and result reading. Software must be 21 CFR Part 11 compliant, and the instrument must be a benchtop model no larger than 24"x24"x24". The solution must be turn-key, newly manufactured, and include installation, on-site operator training, and a minimum one-year warranty with technical support.
Contract & Timeline
- Type: Sources Sought / Market Research
- Set-Aside: No formal set-aside; targeting small businesses, but all interested parties are encouraged to respond. Domestic product offerings are encouraged.
- Response Due: March 10, 2026, 1:00 PM Central Time
- Published: March 4, 2026
- Place of Performance: FDA/IRVLMP, 19701 Fairchild, Irvine, CA 92612
- Period of Performance (anticipated): Delivery, installation, and training within 90 calendar days from award.
Submission Requirements
Respondents must submit a capability statement demonstrating regular engagement in the sale of similar products/services. Submissions should include:
- Business name, UEI, address, website, business size status, and point of contact information.
- Past performance details for similar products/services, including client and manufacturer information.
- Descriptive literature, brochures, and marketing material.
- Sufficient technical information to confirm meeting all specified requirements.
- Identification of any Best in Class (BIC) or GSA Schedule contracts.
- If a large business, details on subcontracting opportunities for small businesses.
- Standard commercial warranty and payment terms.
- Place of product manufacture/service performance for Buy American Act considerations.
- Informational pricing is desired.
Additional Notes
This is for market research purposes only and is not a request for proposal or solicitation. The Government is not obligated to award a contract or pay for information provided. Responses must demonstrate capability and should not include proprietary or sensitive information. Failure to comment on restrictive requirements will be interpreted as confirmation of adequacy.