Requirements_Automated_Liquid_Handler.docx

U.S. Food and Drug Administration Requirements Document Automated Liquid Handling Platform FSB Version 1.0 | Date: 8/28/2026 Review copy: highlighting legend This is a review copy. Highlighting shows where the content came from and what is still open. Green: content derived from the program office source document, whether carried verbatim or converted. Yellow: unresolved item, a value not yet supplied or awaiting a program office answer. Cyan: conditional content, included only where a documented condition applies. Unhighlighted: FSB standard language. Green highlighting is removed to produce the clean release copy; yellow items must be resolved and cyan content kept or deleted before release.

1. Purpose This document states the technical and service requirements for the acquisition of one (1) automated liquid handling platform, including the dedicated control computer, adaptors, and attachments, the manufacturer's standard commercial warranty.

2. Background The Laboratory of Hepatitis Viruses, Center for Drug Evaluation and Research, within the U.S. Food and Drug Administration (FDA) requires an automated liquid handling platform. The Laboratory of Hepatitis Viruses studies viral immunology and vaccines related to hepatitis C virus. The research includes assessment of vaccine platforms and approaches to assessing the quality of antibody responses at the single epitope level, which involves the pipetting of multiple samples in small volumes. The platform will enhance laboratory throughput, improve precision and accuracy in liquid transfers, and reduce manual pipetting errors in support of FDA laboratory operations. The acquisition includes the manufacturer's warranty and ancillary preventative maintenance to sustain performance over the equipment's initial service life.

3. Scope This acquisition includes:

1. Delivery and installation of the automated liquid handling platform, dedicated control computer, adaptors, and attachments

1. The initial manufacturer's warranty

1. User training

1. Technical documentation The preventative maintenance is ancillary to the equipment purchase and is acquired as part of this supply action.

4. Equipment Requirements All equipment shall be newly manufactured. It shall not be used, refurbished, reconditioned, remanufactured, or previously used for demonstration.

Salient characteristics and any single-source need The equipment shall meet the following salient characteristics: a benchtop automated liquid handling platform, user-friendly and easy to operate and clean, of space-saving and energy-saving design, capable of fast automatic pipetting of multiple solutions and of serial dilutions across or down the plate; able to accommodate variable liquid volumes; able to pipette into single rows, single columns, or individual wells as selected by the user in a 96-well or 384-well format, with the well format interchangeable based on user requirements; customizable to the laboratory's assay needs; equipped with programmable operating temperatures permitting use across a range of temperatures; and usable within the containment enclosure identified in the minimum technical requirements below to permit handling of sterile or hazardous materials.

Based on our research, only a specific make and model meets our needs, the Agilent Technologies Bravo Automated Liquid Handling Platform. It is the only equipment in its class that can meet our minimum needs as listed in the specifications. Other machines do not dispense low volumes, are much larger than this machine and do not fit within a biosafety cabinet.

Minimum technical requirements The equipment shall meet the following minimum requirements:

1. The platform shall be benchtop in format and shall fit and operate within a biosafety cabinet of dimensions of 46in W X 24in D X 30in H that will support 120 lbs without disrupting the enclosure airflow.

1. The platform shall perform serial dilutions either across the plate or down the plate using standard disposable tip heads.

1. The platform shall use 96-channel or 384-channel pipetting heads that are interchangeable, with independent tip pickup capability.

1. The platform shall provide a minimum 15-position deck capacity.

1. The platform shall dispense from 0.1 to 200 microliters. Dispensing accuracy and precision shall be no worse than 5% deviation.

1. The platform shall be configurable to support shaking, heating, cooling, and filtration. These configurations are not required to be delivered with the platform; however, the platform shall be capable of accepting these configurations at a later date, if desired.

1. The platform shall include a controller and software to generate custom protocols.

1. The platform shall include a dedicated computer to control the machine.

1. The platform shall be compatible with standard format microplates (96-well and 384-well).

1. The platform shall operate under ambient conditions of 5 to 40 degrees Celsius and 10 to 90 percent relative humidity, non-condensing. No deck or plate temperature-control range is required.

1. Compliance with all applicable Federal, state, and local safety standards

5. Information Technology and Accessibility The platform includes a dedicated control computer and instrument control software used to generate custom protocols. The computer will not be connected to the FDA network or transmit or store data. The computer will only host the instrument control software and configuration files. The computer will be a Windows PC and the automation control software is workstation-bound with a perpetual license.

6. Warranty Requirements Consistent with RFO 12.105(b), the Government will accept the contractor’s standard commercial warranty to the maximum extent practicable and use that warranty for the repair and replacement of the equipment. The warranty shall provide, at a minimum:

1. A full manufacturer's warranty of 12 months from the date of final acceptance

1. Warranty coverage of all parts, labor, travel, and technical support required to return the system to full operating condition

1. Technical support by phone or email during standard business hours

7. Ancillary Maintenance Requirements

1. At least one on-site preventative maintenance visit

1. Inspection, calibration, and cleaning of all system components

1. Replacement of wear-and-tear parts and consumables as needed

1. Performance testing to confirm continued compliance with the equipment specifications

1. Full documentation of each service visit, including work performed and equipment condition

8. Training and Documentation The contractor shall provide:

1. On-site operator training for up to 3 personnel

1. User manuals, maintenance guides, and system schematics in electronic format

1. Safety data sheets (SDS), if applicable

1. Installation qualification (IQ) documentation

1. Operational qualification (OQ) test records

9. Delivery and Installation

1. Equipment shall be delivered to: U.S. Food and Drug Administration, White Oak Campus, 10903 New Hampshire Avenue, Building 52/72, Room 1256, Silver Spring, MD 20993

1. 14 days prior to delivery, a pre-installation planning meeting between FDA receiving staff and the contractor personnel responsible for delivery, installation, and training shall confirm tasks, deliverables, and schedules

1. Delivery shall occur within 30 days of award

1. Installation shall be completed within 90 days of delivery

1. Installation shall include physical placement and leveling of the instrument.

1. Installation shall include electrical connections.

1. Installation shall include computer workstation setup and software installation.

1. The contractor shall conduct operational qualification (OQ) testing and shall provide installation qualification (IQ) documentation.

1. The contractor is responsible for all setup, calibration, and verification of system performance

1. For all on-site work, contractor personnel shall report to security at the FDA White Oak Campus, 10903 New Hampshire Avenue, Silver Spring, MD 20993, who will contact the Contracting Officer's Representative (COR) or the COR's designee. Contractor personnel shall be escorted by the COR or the COR's designee at all times while on-site. On-site work shall be performed during 9:00 a.m. to 5:00 p.m. ET, Monday through Friday, unless otherwise directed by the COR

1. The contractor shall package and mark the equipment for safe transit and shall identify any special handling, temperature, orientation, or shock and vibration limitations on the exterior of each container.

1. Delivery access at the installation location: deliveries will be to loading dock in building 52. Delivery to the room is not required.

10. Acceptance Criteria The Government will inspect and test the equipment upon installation. Final acceptance is based on:

1. Successful completion of installation and system verification

1. Successful completion of operational qualification (OQ) testing and receipt of installation qualification (IQ) documentation

1. Verification that dispensing accuracy and precision meet the tolerances stated in Section 4, measured at 100ul volume – 96 replicates (1 96-well plate).

1. Completion of training and receipt of documentation

1. No outstanding deficiencies at the time of inspection The warranty period and the maintenance period both begin at final acceptance.

11. Holidays and Government Closures The contractor is not required to perform on-site services on the following Federal holidays, or on any other day designated as a holiday for the Washington, DC area:

1. New Year's Day

1. Martin Luther King Jr. Day

1. Presidents' Day

1. Memorial Day

1. Juneteenth National Independence Day

1. Independence Day

1. Labor Day

1. Columbus Day

1. Veterans Day

1. Thanksgiving Day

1. Christmas Day

1. Inauguration Day (every four years, for performance sites in the DC area)

12. Points of Contact See contract for points of contact.