Automated Media Preparation Instrument for Dissolution Testing
Closed Solicitation Posted
- Solicitation number
- 75F40126Q00201
- Agency
-
FDA Office of Acquisition and Grant Services
Food and Drug Administration, Department of Health and Human Services
- Responses due
- Set-aside
- No set-aside
Opportunity facts
- NAICS code
- 334516 Analytical Laboratory Instrument Manufacturing
- Place of performance
- Irvine, California 92612, United States
- Points of contact
Notice details come from SAM.gov. Updated .
About this opportunity
The FDA Office of Acquisition and Grant Services seeks purchase, delivery, installation, operator training, and one-year warranty support for one Automated Media Preparation Instrument for Dissolution Testing, with proposals due July 8. This is a brand-name-or-equal procurement using the Distek ezFill+ as the reference standard; systems of equal capability meeting all salient characteristics are eligible.
Place of performance is the FDA Irvine Medical Products Laboratory, Irvine, California. The instrument must deliver volumes between 250 milliliters and 1,000 milliliters with dispensing accuracy of 5 milliliters or less, include in-line heating to at least 45 degrees Celsius with temperature accuracy of 2 degrees Celsius or better, degas media to a maximum of 3.0 ppm, support media containing up to 2% surfactants, feature onboard programmable operation with report storage, include a portable cart mechanism, and be compatible with standard U.S. electrical service (115V, 50/60 Hz). Installation shall be performed by an OEM-trained and certified field service engineer and include operational verification testing. Operator training for two users shall be provided at the Government site. The warranty covers parts, labor, travel, technical support, and OEM-certified service for a minimum twelve months from Government acceptance.
Delivery must be completed within sixty days after contract award; installation must be completed no later than thirty days after delivery. The NAICS code is 334516, Analytical Laboratory Instrument Manufacturing, with no set-aside. Award will be made to the lowest-priced offeror whose offer is technically acceptable on a pass/fail basis under a Firm-Fixed-Price contract. Questions are due June 8 at 12:00 p.m. EST. Solicitation number is 75F40126Q00201.
Notice text
The U.S. Food and Drug Administration (FDA), Irvine Medical Products Laboratory (IRVLMP), has a requirement for the purchase, delivery, installation, operator training, and warranty support of one (1) Automated Media Preparation Instrument for Dissolution Testing. This acquisition will be conducted as a brand-name-or-equal procurement under NAICS 334516.
The instrument shall provide automated preparation of dissolution media for laboratory testing and be capable of heating, degassing, and dispensing dissolution media in accordance with the Government's minimum technical requirements. Salient characteristics include automated media preparation, precise dispensing accuracy, in-line heating, temperature control, media degassing capability, onboard programmable operation, reporting functionality, portability, compatibility with standard U.S. electrical service (115V, 50/60 Hz), and the ability to fill dissolution vessels while installed on dissolution apparatus.
The Contractor shall furnish all labor, materials, equipment, transportation, installation, operator training, warranty support, documentation, and other resources necessary to provide a fully operational system. Installation shall be performed by an OEM-trained and certified field service engineer and shall include operational verification testing. Operator training for two (2) users shall be provided at the Government site.
The Contractor shall provide a minimum twelve (12)-month manufacturer's warranty covering parts, labor, travel, technical support, and OEM-certified service. Required deliverables include the automated media preparation instrument, installation and qualification, operator training, service documentation, and warranty documentation.
Delivery shall be completed within sixty (60) days after contract award. Installation shall be completed no later than thirty (30) days after delivery at the FDA Irvine Medical Products Laboratory, Irvine, California. Final Government acceptance will occur following successful delivery, installation, operational verification, completion of training, and confirmation that the equipment meets all requirements specified in the solicitation.
Files
| File | Type | Posted |
|---|---|---|
| OC-2026-133856 Combined Synopsis_Supplies.pdf | ||
| OC-2026-133856 Combined Synopsis_Supplies.docx | DOCX document | |
| Combined_Synopsis_Solicitation.docx | DOCX document |
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