SSN.docx
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- Solicitation number
- SSN_OC_2026_133856
About this file
This is a Sources Sought Notice (market survey announcement) issued by the U.S. Food and Drug Administration (FDA), Office of Acquisitions and Grants Services, on behalf of the Office of Chief Science. The FDA is seeking to identify vendors capable of supplying an Automated Media Preparation Instrument for Dissolution Testing and to determine if adequate competition exists for a potential small business set-aside. The reference standard for this brand-name-or-equal acquisition is the Distek ezFill+ Dissolution Media Preparation Instrument. The required instrument must deliver volumes between 250ml and 1,000ml with dispensing accuracy of 5mL or less, include in-line heating to at least 45°C with temperature accuracy of 2°C or better, be capable of degassing media to 3.0ppm maximum, support media with up to 2% surfactants, feature an onboard controller with stored program capabilities, generate dispensing reports, be portable with an included cart, and be compatible with standard U.S. electrical outlets (115V, 50/60 Hz). The NAICS code is 334516 with a small business size standard of 1,000 employees.
The requirement will be awarded as a Firm-Fixed-Price purchase for one unit including supply, delivery, installation, operator training, and one-year manufacturer's warranty. Delivery must occur within 60 days of award at the FDA Irvine Medical Products Laboratory in Irvine, California, with installation completed no later than 30 days after delivery. Service reports are due within 5 business days following qualification and training completion. Responses to the sources sought notice are due by May 10, 2026, and should be submitted via email to Reagan Davis, Contract Specialist, at Reagan.Davis@fda.hhs.gov. Vendors should provide company information, CAGE Code, UEI, NAICS code, company size and socio-economic status, relevant GSA Schedule or government-wide contracts, domestic manufacturing status, and technical specifications. This announcement does not commit the Government to award a contract, and no reimbursement will be provided for response costs.
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SOURCES SOUGHT NOTICE
TITLE: Automated Media Preparation Instrument for Dissolution Testing Notice Number: SSN_ OC-2026-133856 THIS IS A SOURCES SOUGHT ANNOUNCEMENT, A MARKET SURVEY FOR WRITTEN INFORMATION ONLY. THIS IS NOT A SOLICITATION ANNOUNCEMENT FOR PROPOSALS AND NO CONTRACT WILL BE AWARDED FROM THIS ANNOUNCEMENT. NO REIMBURSEMENT WILL BE MADE FOR ANY COSTS ASSOCIATED WITH PROVIDING INFORMATION IN RESPONSE TO THIS ANNOUNCEMENT OR ANY FOLLOW-UP INFORMATION REQUESTS. NO TELEPHONE CALLS WILL BE ACCEPTED REQUESTING A RFQ PACKAGE OR SOLICITATION. THERE IS NO RFQ PACKAGE OR SOLICITATION. TO PROTECT THE PROCUREMENT INTEGRITY OF ANY FUTURE PROCUREMENT, IF ANY, THAT MAY ARISE FROM THIS ANNOUNCEMENT, INFORMATION REGARDING THE TECHNICAL POINT OF CONTACT WILL NOT BE GIVEN AND NO APPOINTMENTS FOR PRESENTATIONS WILL BE MADE.
The U.S. Food and Drug Administration (FDA), Office of Acquisitions and Grants Services (OAGS), is issuing this sources sought announcement on behalf of the Office of Chief Science (OCS) to:
a) identify vendors capable of providing the equipment and service as detailed in this notice, and
b) vendors capable of providing a domestic product offering. Responses from small businesses are appreciated and accepted. The Government is particularly interested in responses from small business concerns, including small disadvantaged businesses, 8(a), HUBZone, service-disabled veteran-owned small businesses (SDVOSB), and women-owned small businesses (WOSB). Responses to this notice will be used to determine whether adequate competition exists to support a small business set-aside.
NAICS Code: 334516 Small Business Size Standard: 1,000 employees Background The Food and Drug Administration (FDA), Irvine Medical Products Laboratory (IRVLMP) performs analytical chemistry testing on medical products to determine if they meet USP and other regulatory requirements. Dissolution testing is frequently performed on tablets and capsules to ensure they meet USP monograph requirements. In order to efficiently and accurately perform dissolution testing an automated media preparation instrument is needed to appropriately de-aerate, heat, and dispense specified amounts of dissolution testing media.
Objective This requirement is being conducted as a brand-name-or-equal acquisition using the Distek ezFill+ Dissolution Media Preparation Instrument as the reference standard for required performance characteristics.
Distek ezFill+ Dissolution Media Preparation instrument is referenced to describe the required performance capabilities. Systems of equal capability that meet all required characteristics will be considered.
SALIENT CHARACTERISTICS
| • | 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. |
Scope of Requirement This requirement will be acquired as a Firm-Fixed-Price (FFP) purchase for the supply, delivery, installation, operator training, and warranty support of one (1) Automated Media Preparation Instrument for Dissolution Testing. Delivery and installation shall occur at the FDA Irvine Medical Products Laboratory (IRVLMP), Irvine, California, or other FDA-designated location identified at time of award.
Deliverables
• Automated Media Preparation Instrument for Dissolution Testing
• Installation, operational verification/IQ-OQ, and operator training.
• Service report documenting instrument qualification
• Manufacturer’s standard one-year warranty covering parts, labor, and operational support.
Schedule:
• Delivery within 60 days after award.
• Installation date to be agreed upon with the technical POC at the delivery location. No later than 30 days after delivery.
• Service reports within 5 business days following the completion of the instrument qualification and training.
• Warranty begins at the completion of installation and Government acceptance through one year.
The equipment shall be delivered 60 days from contract award unless the Government approves a different delivery schedule. The 1-year manufacturer’s warranty shall begin upon final receipt and acceptance by Government of the equipment. Delivery will be accepted during regular business hours (Monday-Friday) during the times of 8:00 AM – 4:00 PM local Time.
Requested Information from Vendors Please provide the following information:
- Company's name, mailing address, Cage Code, and Unique Entity Identifier (UEI)
- Recommended North American Industry Classification System (NAICS) code that your company utilizes for in support of the following equipment: Automated Media Preparation Instrument for Dissolution Testing
- What is your company size? If small, what is your socio-economic status?
- Identify any GSA Schedule contract or other current government-wide contract (e.g., GWAC or BPA) that your company currently holds and offers these products/services under.
- Domestic manufacturing status.
- Technical specifications for the proposed solution.
Disclaimer and Important Notes This is not a Request for Quote (RFQ) and does not commit the Government to award a contract. Responses will be used solely for market research. The FDA will not provide feedback or evaluations of submitted capabilities. Proprietary information should not be submitted.
Submission Instructions Responses are due by May 10, 2026, and shall be submitted via email to:
Name: Reagan Davis Contract Specialist Email: Reagan.Davis@fda.hhs.gov Subject: Sources Sought Notice Number: SSN_ OC-2026-133856
– Automated Media Preparation Instrument for Dissolution Testing
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