Automated Media Preparation Instrument for Dissolution Testing

Project ID: SSN_OC_2026_133856 FederalOpportunitiesSources Sought

Overview

Agency	Food and Drug Administration
Deadline	05/19/26
Posted	05/13/26
Estimated Value	Not Provided
Set Aside	SBA
NAICS	334516 - Analytical Laboratory Instrument Manufacturing
PSC	6632 - Analysis Instruments, Medical Laboratory Use
Location	Irvine, CA 92612 United States

Description

Primary Latest Change

Summary

This requirement is being acquired as a brand-name-or-equal procurement. Equal products meeting all stated salient characteristics will be considered. - - The instrument shall be capable of delivering a minimum volume of 250ml and a maximum volume of at least 1000ml. - The instrument shall have a dispensing accuracy of 5mL or less. - The instrument shall be equipped with in-line heating that is capable of heating dissolution media to at least 45 C. - The instrument shall have a temperature accuracy of 2 C or better. - The instrument shall be capable of degassing media up to a maximum of 3.0ppm. - The instrument shall be compatible with media containing up to a maximum of 2% surfactants. - The instrument shall have an onboard controller and user interface to select stored programs and set parameters for manual use. - The instrument shall be capable of storing programmed methods and running in automatic or manual mode when preparing dissolution media. - The instrument shall be capable of storing dispensing reports that include the volume and temperature dispensed. - The instrument shall be portable with a cart or other mechanism, included, to allow the instrument to be moved to each dissolution instrument for use. - The instrument shall be equipped with a dispensing nozzle that allows for dissolution vessels to be filled in place, while on the dissolution apparatus. - Electrical requirement must be compatible with a standard US outlet, 115V, 50 or 60 Hz.

Safety Requirements

The Contractor shall ensure all equipment complies with applicable laboratory safety standards and manufacturer safety requirements. All installation activities shall be performed in accordance with applicable safety regulations to prevent hazards to personnel and facilities.

Trade and Service Specifications

- The instrument must be a newly manufactured unit, not used and refurbished or previously used for demonstration. - FOB Point destination to include inside delivery and clean-up of area after installation. - The entire system must be warranted for parts and labor for a minimum of 12 calendar months from the date of formal government acceptance. The vendor must also be capable of servicing the instrument through the covered warranty period. The system must include, at a minimum: coverage on all non-consumable items and parts supplied including base instrument, factory-certified replacement parts, engineer labor and travel costs. Any equipment repair and maintenance work shall be performed by an OEM-trained engineer. This factory-trained engineer shall have (verified by the OEM) the following: 1) access to OEM factory telephone support; 2) access to the most current OEM factory training for both hardware and software components; and 3) access to all current OEM factory parts, not build-to-order parts. The OEM-trained service engineer shall not use salvaged parts from other instruments for performing maintenance and repairs. All parts used in PM and repairs must be guaranteed, factory-tested, OEM quality parts. - Instrument operators shall have access, for the duration of the 12-month warranty period, to a technical representative call center at no additional charge, for technical assistance and trouble-shooting, which is staffed by senior engineers to provide a high level of expertise for troubleshooting the instrument. - Operator level training for 2 users at the delivery onsite location shall be provided at time of installation or shortly thereafter (within 30 days), such that operators are able to independently operate the instrument and included software to conduct routine analyses on the instrument. - The Contractor shall provide installation by a trained and certified field service engineer who shall perform the necessary verification testing to demonstrate that the instrument meets the Original Equipment Manufacturer's operational standards following installation. Consumables used for the installation shall be included.

Records and Reports

The Contractor shall, commensurate with the completion of each service call (inclusive of warranty service), provide the end-user of the equipment with a copy of a field service report/ticket identifying the equipment name, manufacturer, model number, and serial number of the equipment being serviced/repaired and detailing the reason for the service call, a detailed description of the work performed, the test instruments or other equipment used to affect the repair or otherwise perform the service, the name(s) and contact information of the technician who performed the repair/service, and for information purposes, the on-site hours expended and parts/components replaced. In addition, the Contractor shall provide monthly reports to the FDA Project Officer and Contract Specialist, not later that the 5th workday following the end of each month, summarizing all maintenance and repair activities (including warranty work) for the previous month (during months that work is performed).

Summary (Newest Update)

Background The U.S. Food and Drug Administration (FDA), Office of Acquisitions and Grants Services (OAGS), is seeking vendors capable of providing an Automated Media Preparation Instrument for Dissolution Testing. This requirement is essential for the FDA's Irvine Medical Products Laboratory (IRVLMP) to perform analytical chemistry testing on medical products, specifically dissolution testing on tablets and capsules to ensure compliance with USP monograph requirements. The goal is to acquire a system that can efficiently de-aerate, heat, and dispense specified amounts of dissolution testing media. Work Details The contract involves the supply, delivery, installation, operator training, and warranty support for one Automated Media Preparation Instrument for Dissolution Testing. The instrument must meet the following salient characteristics: - Capable of delivering a minimum volume of 250ml and a maximum volume of at least 1000ml. - Dispensing accuracy of ±5mL or less. - Equipped with in-line heating capable of heating dissolution media to at least 45°C. - Temperature accuracy of ±2°C or better. - Capable of degassing media up to a maximum of 3.0ppm. - Compatible with media containing up to a maximum of 2% surfactants. - Onboard controller and user interface for selecting stored programs and setting parameters for manual use. - Capability to store programmed methods and operate in automatic or manual mode when preparing dissolution media. - Capability to store dispensing reports including volume and temperature dispensed. - Portable with included cart or mechanism for movement between dissolution instruments. - Equipped with a dispensing nozzle allowing dissolution vessels to be filled in place on the apparatus. - Electrical requirement compatible with standard US outlet (115V, 50 or 60 Hz). Period of Performance Delivery within 60 days after award; installation no later than 30 days after delivery; warranty begins upon completion of installation and Government acceptance for one year. Place of Performance FDA Irvine Medical Products Laboratory (IRVLMP), Irvine, California, or other FDA-designated locations.

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