MICROWAVE DIGESTION SYSTEM WITH ACCESSORIES

. INTRODUCTION

This is a Sources Sought Notice only. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding the availability and capability of qualified small business sources to provide the equipment and services described herein. The Government will use the information obtained to determine the appropriate acquisition strategy and set-aside determination.

Responses to this notice are not offers and cannot be accepted by the Government to form a binding contract.

2. AGENCY INFORMATION

Agency: U.S. Food and Drug Administration (FDA)
Office: Office of Regulatory Affairs (ORA)
Laboratory: Irvine Medical Products Laboratory (IRVLMP)
Location: 19701 Fairchild Road, Irvine, CA 92612

3. REQUIREMENT DESCRIPTION

3.1 Background

The FDA Irvine Medical Products Laboratory performs elemental analysis on regulated commodities to detect trace levels of toxic elements. IRVLMP requires a microwave digestion system with accessories to automate the digestion process for regulated commodities to increase efficiency and reduce analytical timeframes for actionable results.

3.2 Scope

Purchase of one (1) Microwave Digestion System with Accessories that meets or exceeds the technical requirements specified below.

4. TECHNICAL REQUIREMENTS

The contractor shall provide a Blade microwave digestion system with accessories or equivalent meeting or exceeding the following requirements:

4.1 System Capabilities

• Utilizes fully automatic management of loading and unloading of vessels from the digestion chamber
• Utilizes sequential, continuous microwave digestion for sample processing
• Equipped with at least a 24-position sample rack
• Equipped with a high-definition camera for real-time viewing of digestion process
• Equipped with a high-resolution display to monitor camera feed in real-time and control the instrument
• Equipped with pressure and temperature control for each individual sample
• Utilizes barcode scanning for sample recording
• Does not require an external chiller
• Does not require an external gas source
• Equipped with a stirring option for samples

4.2 Electrical Requirements

• Single 110-120V outlet

4.3 Vessel Requirements

• Instrument utilizes quartz vessels with options available for Teflon inserts
• At least 24 quartz vessels are provided with the instrument
• Sufficient number of caps and septa for installation and training activities included

4.4 Physical Specifications

• Instrument footprint should be no larger than 24 inches (width) x 24 inches (depth) x 36 inches (height)

4.5 Accessories

Must include:
- Exhaust hose
- At least one set of sample racks
- Barcode scanner
- Vessel stand and holder

5. TRADE AND SERVICE SPECIFICATIONS

5.1 Equipment Condition

• Must be a newly manufactured unit, not used, refurbished, or previously used for demonstration

5.2 Delivery

• FOB Point destination to include inside delivery and clean-up of area after installation
• Delivery required within 90 days from contract award

5.3 Warranty

• Entire system must be warranted for parts and labor for a minimum of 12 calendar months from the date of formal government acceptance
• Coverage on all non-consumable items and parts supplied including base instrument, factory-certified replacement parts, engineer labor and travel costs
• Vendor must be capable of servicing the instrument through the covered warranty period

5.4 Service Requirements

• All equipment repair and maintenance work shall be performed by an OEM-trained engineer with:

• Access to OEM factory telephone support
• Access to the most current OEM factory training for both hardware and software components
• Access to all current OEM factory parts (not build-to-order parts)

• No salvaged parts from other instruments may be used
• All parts used in preventive maintenance and repairs must be guaranteed, factory-tested, OEM quality parts

5.5 Installation

• Installation by an OEM trained field service engineer
• Necessary verification testing to demonstrate that the instrument meets the Original Equipment Manufacturer's operational standards following installation
• Calibration solutions and consumables used for installation shall be included

5.6 Training

• Operator level training for 2 users at the delivery onsite location
• Training to be provided at time of installation or shortly thereafter (within 30 days)
• Training shall enable operators to independently operate the instrument and included software to conduct routine regulatory analyses
• Training shall include manuals and any consumables to be used during training

5.7 Records and Reports

• Field service report/ticket required after each service call (including warranty service) identifying:
• Equipment name, manufacturer, model number, and serial number
• Reason for service call
• Detailed description of work performed
• Test instruments or equipment used
• Technician name(s) and contact information
• On-site hours expended and parts/components replaced

6. DELIVERABLES

Description of Deliverable

Qty

Due Date

Microwave Digestion System with Accessories

Delivery within 90 days after award

Installation and training

Date to be agreed upon with technical POC at delivery location. No later than 30 days after instrument delivery

Manufacturer's warranty of equipment, parts and operational services

Begins with final receipt and acceptance by the Government

7. PLACE OF PERFORMANCE

Delivery Location:
FDA/IRVLMP
19701 Fairchild Road
Irvine, CA 92612

Delivery Hours:
Monday-Friday, 8:00 AM – 4:00 PM local time

8. ESTIMATED PERIOD OF PERFORMANCE

• Delivery: Within 90 days from contract award
• Warranty Period: 12 months from final receipt and acceptance by Government

9. SMALL BUSINESS INFORMATION

The Government is particularly interested in responses from small businesses, including:
- Small Business (SB)
- HUBZone Small Business
- Small Disadvantaged Business
- 8(a) Business Development Program participants
- Service-Disabled Veteran-Owned Small Business (SDVOSB)
- Woman-Owned Small Business (WOSB)

10. REQUESTED INFORMATION

Interested parties should provide the following information in their response:

1. Company Information:

• Company name, address, point of contact, phone number, and email address
• DUNS/UEI number
• CAGE code
• Business size and socioeconomic status (including relevant certifications)
• GSA Schedule contract number (if applicable)

1. Technical Capability:

• Confirmation that your company can provide equipment meeting or exceeding all technical requirements
• Manufacturer name and model number of proposed equipment
• Whether you are the Original Equipment Manufacturer (OEM) or an authorized distributor
• Description of your company's capability to provide installation, training, and warranty services as specified

1. Service Capability:

• Description of your service organization and geographic coverage
• Confirmation that service will be performed by OEM-trained engineers meeting the specified requirements

12. SUBMISSION INSTRUCTIONS

All contractors must complete the attached SSN Response Template form on or before April 13, 2026 @ 10:00am ET.

Submit Responses Via email to Michele.Jackson@fda.hhs.gov

Format: Responses should be submitted via email using the SSN Response Template form and the subject line: "Sources Sought Response - Microwave Digestion System" XXXX (Company Name)

13. DISCLAIMER

This Sources Sought Notice is for informational and planning purposes only and shall not be construed as a solicitation or as an obligation on the part of the Government. The Government will not pay for any information or administrative costs incurred in response to this notice. All submissions become Government property and will not be returned.

The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications and capabilities.

Responses to this notice are not offers and cannot be accepted by the Government to form a binding contract. Responders are solely responsible for all expenses associated with responding to this Sources Sought Notice.

14. POINTS OF CONTACT

Contracting Officer:
Michele Jackson

Michele.Jackson@fda.hhs.gov