Automated Media Preparation Instrument for Dissolution Testing
Contract Overview
Solicitation details, issuing organization, response deadlines, documents, and interested companies for this government contract opportunity.
AI Contract Overview
The U.S. Food and Drug Administration’s Irvine Medical Products Laboratory is seeking to acquire a single automated media preparation instrument for dissolution testing under a brand-name-or-equal procurement identified by NAICS code 334516. The instrument must automatically prepare dissolution media by heating, degassing, and precisely dispensing liquid media while being compatible with standard U.S. electrical service at 115V, 50/60 Hz. Key capabilities include in-line heating with temperature control, onboard programmable operation, reporting functions, portability, and the ability to fill dissolution vessels directly while installed on dissolution apparatus. The contractor is responsible for supplying the complete system including all labor, materials, equipment, and services required for delivery, installation, operator training for two users at the Irvine location, warranty support, and comprehensive documentation. Delivery must be completed within 60 days of contract award, followed by installation no later than 30 days after delivery. Installation must be performed by an OEM-trained and certified field service engineer and must include operational verification testing to confirm full functionality. The contractor must also provide a minimum 12-month manufacturer’s warranty covering parts, labor, travel, technical support, and OEM-certified service. Required deliverables include the instrument itself, installation and qualification records, training materials, and warranty documentation. Final acceptance by the government hinges on successful delivery, installation, operational verification, completed training, and full compliance with all technical and logistical requirements outlined in the solicitation. The procurement is managed by the FDA Office of Acquisition and Grant Services with a response deadline of July 8, 2026, and the point of contact is Reagan Davis at the agency’s Rockville, Maryland office.
General Info
Agency
NAICS
Place of Performance
Irvine, CA, 92612, USASet-Aside
Timeline
Response Deadline
Organization & Contact Information
Full Description
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.