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This is a combined synopsis/solicitation for a Rapid Sterility Instrument prepared in accordance with the Federal Acquisition Regulation (FAR) Part 12. The Food and Drug Administration (FDA) requires a rapid sterility instrument capable of reducing incubation time and providing faster sterility results compared to conventional USP methods. The instrument must utilize ATP bioluminescence technology, be compatible with USP compendial media, and analyze both filterable and nonfilterable pharmaceutical products. Key technical requirements include results within 7 days or less, a testing capacity of at least 28 tests per hour, automated reagent additions and result reading, and 21 CFR Part 11 compliant software. The instrument should be a benchtop model with specific dimension limitations and compatible with standard US electrical outlets. The offered system must be a turnkey solution, including hardware, software, installation, and startup supplies. A 1-year warranty is required, covering troubleshooting, replacement parts, and phone/email technical support. Delivery, installation, and training must occur within 90 calendar days from the date of award. Payment terms are net 30 days after government acceptance of a proper invoice, which must be submitted electronically through the Invoice Processing Platform (IPP). Offerors must submit sufficient technical information to demonstrate compliance with all minimum technical requirements. The government intends to award a contract to the lowest-priced technically acceptable responsible offeror. Offers are due by email only to ***@***. *. * on or before April 3, 2026, by 1:00 p. m. Central Time. All electronic documents submitted must be without the use of macros.
The bid notice states that delivery, installation, and training shall occur within 90 calendar days from the date of award.
The bid notice states that payment terms are net 30 days after government acceptance of a proper invoice.
The bid notice states that systems shall be warranted for not less than one (1) year from FDA acceptance of the systems.
The bid notice states that the government intends to award a contract resulting from this solicitation to the lowest-priced technically acceptable responsible offeror whose quote, conforming to the solicitation, will be most advantageous to the government, price and other factors considered.
The bid notice states that quoters shall provide sufficient technical information necessary for the government to conclusively determine that the offered service/equipment meets all the salient characteristics herein, to include descriptive material, literature, brochures and other information corresponding to each minimum technical requirement which demonstrates the capabilities of the offered system.