Final_SOW_measurement tool REV1.docx

STATEMENT OF WORK

TITLE: Particle Size Measurement Tool LAB REQUESTING SERVICE: Material Measurement Laboratory, Biomolecular Measurement Division Date: May 29, 2026

I. BACKGROUND INFORMATION:

The Bioprocess Measurements Group at the National Institute of Standards and Technology (NIST) located at Gaithersburg, MD provides measurement science and standards for robust characterization of biologically or synthetically derived particles that are relevant in the biomanufacturing industry. These particle types can be hard to distinguish, and regulatory guidelines require detailed characterization of these particles in drug products. Industry currently relies heavily on flow imaging microscopy and light obscuration (compendial method) for characterizing these particles in their products. We are requesting an updated flow imaging instrument with light obscuration capabilities to replace two outdated, unsupported systems (Flow imaging and Light Obscuration) which no longer reflect instruments used in industry which limits data comparability and collaboration. The legacy instruments were instrumental in early steps of SRM 1989 development, measurement of particle concentrations in RGTMs, evaluation of diluent stability, and peer-reviewed studies examining instrument bias between light obscuration and flow imaging, including development of advanced image-analysis approaches such as variable thresholding. Upgrading to a modern, industry-relevant platform that integrates flow imaging microscopy with the compendial light obscuration method will significantly improve confidence, consistency, efficiency, and robustness of particle measurements, strengthen reference material development, and enhance understanding of instrument-specific biases. The instrument will be used to characterize complex mixtures of biological and non-biological particles, including proteinaceous, viral, and cell-based particles, across a size range of approximately 2 µm to 70 µm, and will also enable our group to support emerging therapeutic modalities such as cell and gene therapies. This will ensure alignment with current industry practices, enable meaningful collaborations with industry and standards organizations, advance measurement science and standards development, and mitigate the risk of falling behind evolving measurement challenges in biopharmaceutical manufacturing.

II. SCOPE OF WORK:

The Contractor shall provide a commercial flow imaging microscopy instrument with light obscuration capabilities suitable for measurement of sub-visible particles in liquid suspension with associated data collection and analysis software, consumables, shipping, installation and on-site training for up to three people.

III. SPECIFICATIONS:

The Contractor shall provide one (1) flow imaging microscopy instrument that meets the following minimum salient characteristics:

· Flow imaging microscopy instrument coupled with light obscuration capabilities where a single sample can pass through a flow imaging flow cell and a light obscuration flow cell and conserving sample.

· Digital camera/optics with sufficient sensitivity, resolution, and dynamic range to detect particles with diameters from 2 µm Equivalent Circular Diameter (ECD) up to 70 µm ECD.

· Sample Processing Capability: 0.2 mL / minute

· Sample Volume Range: 250 µL - 2 mL

· Optics consisting of 10X magnification

· No lower concentration limit to upper concentration limit of 1,000,000 mL-1 for 2 µm sized particles

· Ability to download raw images for further, independent analysis

· Ability to export size, concentration, morphology results into tables for post-acquisition data review

· Sample chamber that is disposable or easy to clean

· System must have autofocus capability.

· Vendor shall provide a computer system with the instrument to run data acquisition, data processing and analyzing, and for data storage.

· Vendor shall provide software for data acquisition and analysis, with industry-norm capabilities for instrument calibration.

· Vendor will install the instrument and provide training at the installation site for up to three users.

· Light obscuration data should be compliant with USP <787/788>

· High resolution camera (1920 x 1200 pixels) CMOS (monochrome and color available)

· Frame Rate: Shutters up to 100 frames per second

· Light Obscuration Light Source: Solid-state laser diode, 785 nm

· Light Obscuration Detection Method: Light extinction, volumetric

· Fluidics: Micro-syringe pump with 2.5 mL syringe

· Equipped with the image analysis software Visual Spreadsheet version 6

The Contractor shall provide one Operations and Maintenance manual for the flow imaging microscopy instrument in hard copy or electronic media in .PDF format.

Installation:

The Contractor shall install the instrument in Building 221, Room B329, at NIST Gaithersburg, MD. Installation shall include, at a minimum, uncrating/unpacking of all equipment, set-up and hook-up of all equipment, start-up, demonstration of specifications, and removal of all trash. Instrument will operate to manufacturer’s specifications upon installation. Installation will take place during normal business hours, between 8:30 am and 5:00 pm Eastern Time, Monday through Friday except Federal Holidays, and will be coordinated with the NIST Technical Point of Contact (TPOC).

Warranty:

The Contractor shall provide, at a minimum, a one-year warranty for the equipment. The warranty shall cover all parts, labor and travel. The warranty shall commence upon acceptance by NIST after successful completion of delivery, installation, training and demonstration of all required specifications.

Training:

Include training at NIST for up to three (3) NIST personnel covering normal operation, troubleshooting, and routine maintenance. Training will be provided during normal business hours, between 8:30am and 5:00pm Eastern Time, Monday through Friday, except Federal Holidays, and will be coordinated with the NIST Technical Point of Contact (TPOC) to ensure maximum availability of NIST personnel. The training may be completed on-site at NIST immediately after installation and demonstration of specifications.

IV. PLACE OF PERFORMANCE:

Installation of the instrument and training shall be conducted at NIST, Gaithersburg, Maryland. Core duty hours are Monday through Friday, 8:30 a.m. to 5:00 p.m. except for Federal holidays.

V. DELIVERABLES:

VII. INSPECTION AND ACCEPTANCE:

The NIST TPOC identified in the award will inspect the requested items to determine whether the minimum technical requirements are met. All required subscription renewal, maintenance, and support will be inspected by the NIST TPOC identified at award within three (3) days of the Contractor's provision of subscription renewal, maintenance, and support. Before acceptance, any defects found during inspection shall be corrected by the Contractor within 30 days of notification from the NIST TPOC. All required subscription renewal, maintenance, and support must be accepted by NIST to constitute final acceptance. Any defects encountered after final acceptance will be subject to the Manufacturer’s Warranty.

VIII. PAYMENT SCHEDULE:

The Contractor shall be paid, in accordance with Net 30-day payment terms, upon receipt and acceptance of a proper invoice, in accordance with the following schedule:

-The Government anticipates payment after 100% inspection and acceptance by the Government.

NOTE: Partial shipments and partial invoices will not be accepted, unless otherwise requested and accepted by the Contracting Officer prior to award. Proposed payment schedules shall be submitted with the offeror’s response to the official solicitation for consideration.

IX. GENERAL INFORMATION

Federal holidays:

· New Year's Day (January 1)

· Martin Luther King Jr. Day (Third Monday in January)

· Presidents' Day / Washington's Birthday (Third Monday in February)

· Memorial Day (Last Monday in May)

· Juneteenth (June 19)

· Independence Day (July 4)

· Labor Day (First Monday in September)

· Columbus Day (Second Monday in October)

· Veterans Day (November 11)

· Thanksgiving Day (Fourth Thursday in November)

· Christmas Day (December 25)

Safety: Contractor personnel shall be responsible for knowing and complying with NIST installation safety prevention regulations found here (http://www-i.nist.gov/mml/safety/policies/index.htm.) Such regulations include, but are not limited to, general safety, fire prevention, and waste disposal.

Security: NIST is a restricted campus. An identification badge is required for access for entry into buildings and is shown to the armed Security Police when entering the campus.

Identification Badges: Contractor employees shall comply with NIST identification and access requirements. The Contractor employee is responsible for absences due to expired identification and access documents. Each Contractor employee shall wear a visible identification badge provided by the NIST Security Office. The badge must show the full name, title, and if required by NIST, the words “Contractor” in front. The Contractor employee shall turn in the NIST identification badge and vehicle pass to the TPOC, COR, or Contracting Officer (CO) upon termination of their services under this contract.

Vehicle Registration: All Contractor employees must register their vehicles with the NIST Security Office to gain access to the campus. A valid driver’s license compliant with REAL ID or Government-furnished civilian ID, proof of insurance and current registration must be presented to the NIST Security Office, at which time a NIST vehicle pass will be issued. The pass shall be displayed on the vehicle’s rear-view mirror in accordance with instructions. The Contractor employee shall follow NIST procedures for removal and turn-in of the vehicle pass upon termination of services under this contract.

Media Inquiries: The Contractor employee shall not respond to any media inquiries. Any inquiries from the media shall be immediately relayed to the TPOC, COR, and/or CO. There shall be no interviews, comments, or any other response without the knowledge and approval of the NIST Director.