Attachment 2_SOW_OC-2026-135575.pdf

ALP: OC-2026-135575

Ion Chromatography System 1

STATEMENT OF WORK

One (1) Ion Chromatography System

Background

The National Forensic Chemistry Center (NFCC), within the Office of the Commissioner/Office of the Chief Scientist/Office of Specialty Laboratories & Enforcement Support (OC/OCS/OSLES), requires the purchase of one (1) ion chromatography system with the ability to perform inorganic anion analysis and High- Performance Anion Exchange Chromatography - Pulsed Amperometric Detection (HPAEC-PAD) through a dual-channel system that enables concurrent sample runs.

The system must also be capable of operating in tandem with a mass spectrometer system. Acquisition of the IC system will continue to support the FDA's mission to protect the public health and support criminal and regulatory investigations involving foods, drugs, dietary supplements, and medical products. The system will replace an older, unsupported ion chromatography system and provide enhanced capabilities for determining the presence of anions; carbohydrates, including derivatives such as alcohols and glycols; and small organic acids.

Objective

NFCC regularly provides support to CDER, CBER, and various offices within the Office of Inspections and Investigations, including the Office of Criminal Investigations and the Office of Import Operations, as well as other federal, state, and local agencies outside of the FDA, in the analysis of foods, drugs, dietary supplements, and medical products suspected of being harmful to consumers. Additionally, this type of system is required to support forensic laboratory sample analysis during mission-critical CORE public health outbreak responses by enabling the timely and accurate detection of low concentrations of ions in potentially hazardous ingredients and products. The anionic detection capabilities of this system allow for the detection of anionic components, such as chloride, associated with a diluent (e.g., saline). This capability is especially useful in tampering/theft cases where scheduled drugs are removed and replaced or diluted. The new instrument will provide enhanced consumable monitoring for increased traceability and increased high-pressure capabilities for faster separations. The new IC system will support updated suppressors and changes to the eluent generator for faster, more consistent, and reliable results that the aging system lacks.

Order Type

FDA intends to award an order on a brand name or equal basis for the items described below.

Ion Chromatography System 2

Scope

The National Forensic Chemistry Center (OC/OCS/OSLES/NFCC) requires the purchase of one (1) ion chromatography system with conductivity detection, electrochemical detection, and mass spectrometer detection capabilities. The system must meet or exceed the minimum performance requirements and salient characteristics identified below.

REQUIREMENTS

MINIMUM PERFORMANCE REQUIREMENTS / SALIENT CHARACTERISTICS

All of the following system requirements are minimum requirements. Any proposed equivalent that differs from these minimum requirements shall be identified and justified by the proposing vendor and will be evaluated by NFCC prior to purchase.

General Requirements

• The system must include an ion chromatograph consisting of a gradient dual pump, eluent generator module, autosampler, conductivity detector (CD), pulsed electrochemical detector (ED), working electrode, pH reference cell, chromatography compartment, and software.

• The system shall be delivered with all necessary supplies and accessories required for installation and start-up.

• The delivered system shall include one set of installation and service manuals and all preloaded computer software required to operate the IC, conductivity detector, electrochemical detector, and other system components.

Ion Chromatograph (IC)

• The IC must be equipped with a dual pump system providing independent pumping capabilities in the same module, with the ability to operate simultaneously or independently (e.g., anions and carbohydrates, or an external water source to a mass spectrometer).

• The IC must be equipped with an integrated vacuum degasser with one channel for the isocratic pump and four channels for quaternary pumps.

• The system shall automatically stop pump flow in the event of leaks, flow restrictions, or depleted eluent reservoirs.

• The IC should have an integrated piston seal wash to prevent eluent crystallization on seal surfaces.

• The system should have front panels displaying the status of module power, injection valve position, and alarms.

• The IC system must be able to operate at a pressure up to 5000 PSI.

Ion Chromatography System 3

• The eluent generator must be able to operate at a flow rate of 0.1 to 3.000 mL/min.

• The system should be compatible with a range of eluent types including, but not limited to, KOH, NaOH, and carbonate/bicarbonate.

• The IC system can operate at 0.000–10.000 mL/min with settable flow increments at 0.001 mL/min, without changing pump heads.

• The IC must be equipped with an eluent generator module to provide generation of high-purity eluents and to run gradient separations.

• The IC system must be equipped with a DC detector and chromatography module which houses valves and columns for the separation, detection, and automation of an analysis.

• The system shall maintain a dual-temperature-zone configuration, controlling the injection valve and column compartment separately from the upper compartments.

• The system shall automatically detect valves, CD/ED cells, and suppressor devices through the software.

• Manual loading of samples shall be possible, if needed.

• The system shall operate with 2 mm and 4 mm guards and columns.

Autosampler

• The IC autosampler must allow simultaneous injections, including concurrent injection of a sample onto two systems running a given application.

• The system must use one autosampler to control the dual pump systems, with sequential injections allowing increased sample throughput.

• The system should provide reproducibility with RSDs less than 0.3% for full loop injections.

• The system shall be fitted with a moving needle designed to ensure reliable sampling from a variety of vial sizes.

• The autosampler should hold 120 or more 0.3-mL and/or 1.5-mL vials and 81 10-mL vials.

• The autosampler must have a sample tray temperature-control option for thermally sensitive samples that provides precise, reliable control over a temperature range of 4-60 °C.

• The minimum sample volume includes 10 µL sampled from a 300 µL microvial and 20 µL sampled from a 500 µL microvial.

• The autosampler injection modes shall include a full loop, partial loop, and limited sample modes.

• The system should be able to perform both pull and push modes for sampling techniques.

• The diverter valve of this compartment should support one 2-position, 6- or 10-port configuration.

Ion Chromatography System 4

Conductivity Detector

• The system should have a microprocessor-controlled digital signal processor to detect high and low concentrations of analytes in the same run.

• The detector must support all IC and RFIC system applications with a range up to 15,000 µS.

• The conductivity detector must be controlled through the software.

• The CD should mount inside the DC compartment of the system.

• The analytical CD cell shall heat independently from other chromatography components.

• The CD detector should be optimized for the highest signal-to-noise ratio at flow rates up to 10 mL/min.

• The CD compartment should be equipped with a 2 mm or 4 mm suppressor capable of regeneration.

• The CD output range should have a digital or analog signal range of 0-18,000 µS/cm.

Electrochemical Detector

• The system should have a microprocessor-controlled digital signal processor.

• The electrochemical detector must be controlled through the software.

• The ED should mount inside the DC compartment of the system.

• The ED should support DC amperometry, pulsed amperometry, or integrated pulsed amperometry detection modes.

• The system shall have the ability to utilize either a pH-Ag/AgCl, Ag/AgCl, or PdH reference electrode.

• The ED potential range shall be able to operate from –2.0 to 2.0 V in 0.001 V increments.

• The ED signal range shall operate from 0.0008 pC to 200 µC for integrated amperometry and from 0.00008 pA to 74 µA for DC amperometry.

• The ED must have detection capabilities including the use of multiple waveforms and multiple integration times (post-run data processing only) to optimize detection conditions for individual analytes.

• The software controlling the integrated pulsed amperometry mode should provide the ability to change the waveform profile’s number of segments, duration of each segment, and voltage applied at each segment.

• The ED cell and detector electronics should be integrated to minimize noise, maximize electrical isolation and shielding, and maximize thermal stability.

• The ED detector can be used in dual-detection configuration (detectors in series or systems in parallel).

• The system should be compatible with conventional working electrodes, including gold, glassy carbon, platinum, and silver, as well as disposable working electrodes, including gold, platinum, carbon, and silver.

Ion Chromatography System 5

Data System

• The IC system and all components must be controlled through the instrument software so that system status and diagnostics are available within the software.

• The system must include single-instrument software and a computer sufficient to control all components of the IC system and process the resulting data.

• The software must allow for the production of reports based on obtained data.

• The data system must be capable of controlling three IC systems simultaneously.

• Backup of the data and sequence lists must be possible by copying individual files or folders and must not be limited to database-only storage.

Trade and Service Specifications

• The system must be a complete, newly manufactured unit and shall not be used, refurbished, or previously used for demonstration. Routine customer service and technical support must be available from the vendor throughout the system's lifecycle.

• The system shall include a minimum one (1) year warranty on all components. At a minimum, the warranty shall cover all non-consumable items and supplied parts, including the base instrument, computer, monitor, and printer; unlimited on-site service visits with a maximum 72-hour on-site response time; factory-certified replacement parts; engineer labor and travel costs; software updates; and notifications.

• The system must include analyst familiarization at installation.

• The Contractor shall provide on-site analyst familiarization/training for up to five (5) FDA personnel at the time of installation. Training shall include system operation, software use, routine maintenance, and basic troubleshooting.

• The vendor shall provide unlimited telephone and/or email support at no additional cost for one (1) year.

Records and Reports

At the completion of each service call or maintenance repair, including warranty service, the Contractor shall provide the equipment end user with a field service report/ticket.

The report/ticket shall identify the equipment name, manufacturer, model number, and serial number and shall include the reason for the service call; a description of the work performed; the parts cleaned and/or replaced; the results of instrument-related tests confirming operational status; the name(s) and contact information of the technician(s) who performed the repair/service; and, for informational purposes, the on-site hours expended.

Ion Chromatography System 6

Deliverables

Deliverable Quantity Delivery Date

Ion Chromatography System 1 No later than 30 days after contract award.

Ion Chromatography System 7

SHIPPING DESTINATION

One (1) ion chromatography system shall be delivered to and located at the following laboratory:

1) National Forensic Chemistry Center U.S. Food and Drug Administration 6751 Steger Drive Cincinnati, OH 45237

Point of Contact will be given at the time of Contract award.

Normal Government hours of operation are 8:00 am – 4:30 pm ET, Monday through Friday, Eastern Time, excluding Federal holidays and other days when the Government facility is officially closed.

The Contractor shall coordinate the delivery date and time in advance with the Government Point of Contact (POC). Deliveries shall not be made outside normal Government operating hours without prior approval from the Government POC.

PERIOD OF PERFORMANCE

Equipment shall be delivered no later than thirty (30) days after contract award. The Period of Performance begins on the date of formal Government acceptance and continues through the end of the manufacturer's warranty period.

INVOICE SUBMISSION

• Full payment and invoicing shall not be authorized until the Contractor has successfully delivered and installed the system and completed all required training to the satisfaction of the Contracting Officer's Representative (COR).

Routine customer service and technical support shall remain available from the vendor throughout the system's lifecycle.

GOVERNMENT POINTS OF CONTACT

Contracting Officer (CO):

Name: Iris Johnson Email: Iris.Johnson1@fda.hhs.gov Phone: (301)

Contracting Officer’s Representative (COR):

The COR will be given at the time of Contract award.