Automated Media Preparation Instrument for Dissolution Testing

The U.S. Food and Drug Administration’s Irvine Medical Products Laboratory is seeking a single Automated Media Preparation Instrument for Dissolution Testing through a brand-name-or-equal procurement under NAICS code 334516, awarded as a Firm-Fixed-Price contract using the Lowest Price Technically Acceptable methodology. The instrument must reliably automate the preparation of dissolution media with precise dispensing, in-line heating, degassing, and temperature control, while being compatible with media containing up to 2% surfactants and standard U.S. 115V, 50/60 Hz electrical service. It must feature an onboard controller for automatic and manual operation, storage of dispensing reports including volume and temperature, and a portable design with a dispensing nozzle to fill dissolution vessels directly while installed on apparatus. All required deliverables—equipment, installation, operator training for two users, service documentation, and warranty information—must be provided as a complete system, with installation performed by an OEM-certified engineer and verified through operational testing and a validation run using research samples. The contractor must also ensure full compliance with Buy American and Trade Agreements requirements, including submission of country of origin and a Buy American Certificate, and adhere to federal security, labor, and ethical standards including safeguarding of information systems, combating trafficking in persons, and honoring employee rights. Delivery is required within 60 days of contract award, with installation completed no later than 30 days after delivery at the specified site in Irvine, California, during business hours Monday through Friday. Final Government acceptance hinges on successful completion of delivery, installation, operational verification, training, and demonstration of all salient technical requirements, with acceptance occurring within five business days after these milestones are met. Payment is contingent upon Government acceptance and must be submitted electronically via the Treasury’s Invoice Processing Platform, accompanied by a detailed invoice log addendum tracking all payments received to date. The contractor must maintain a minimum 12-month manufacturer’s warranty covering parts, labor, travel, and technical support from the date of acceptance, and all offerors must hold an active Unique Entity Identifier and current SAM.gov registration. All proposals must include technical and price quotations, warranty terms, documentation proving compliance with all technical specifications, and any required certifications for origin and ethical compliance, and are to be submitted electronically in searchable PDF or Excel format by the deadline of July 8, 2026.