Atatchment 1- Statement of Requirement (Final).pdf

STATEMENT OF REQUIREMENT

TITLE: Procurement of a Particle Tracking Analyzer

LAB REQUESTING SERVICE: Material Measurement Laboratory, Biomolecular

Measurement Division

I. BACKGROUND INFORMATION

The Material Measurement Laboratory’s Bioprocess Measurements Group characterizes the size and number concentration of viruses, proteins or protein-like particles and other biological colloidal particles, as well as similarly sized polymeric and inorganic particles. An apparatus implementing particle tracking analysis (aka “nanoparticle tracking analysis” or abbreviated as

PTA) would allow us to accurately measure the size on a single-particle basis as well as the overall number concentration while in native aqueous environments. This instrument will support the NIST program in biomanufacturing, which includes projects on the measurement of proteinaceous particles in biotherapeutic products and the development of reference materials for particle size distribution in the sub-micrometer range. The instrument will be used to study biological particles (e.g., proteinaceous particles, extracellular vesicles) in the size range from 50 nm to 1000 nm, and will also be used to study non-biological particles or particles of heterogeneous composition in this same size range.

This procurement request is to purchase a commercial particle tracking analysis (PTA) instrument suitable for measurement of nano-scale and sub-micrometer particles in liquid suspension with associated data collection and analysis software, consumables, installation and training.

II. SPECIFICATIONS

The Contractor shall provide one (1) particle tracking analyzer instrument system that meets the following minimum specifications:

• Digital camera/optics with sufficient sensitivity and dynamic range to track scatter from particles with diameters down to at least 20 nm and up to at least 1 µm.

• Sizing accuracy of ± 10% over the size range from 20 nm to 1 µm for monomodal samples.

• Particle number concentration measurement dynamic range better than (107 to 108) 1/mL

• Particle number concentration accuracy of ± 20% over the size range from 20 nm to 1 µm for monomodal samples.

• Repeatability for size and particle number concentration better than 5 %

• Capable of resolving discrete multi-modal populations with a size ratio of 1:2 or better.

• Data output required: particle tracks, user-readable videos of particle motion, raw data, basic statistical output (at least: particle size distributions, number of particles tracked/analyzed, and number concentration of particles). Capability to export data

(individual particle measurements) to a non-proprietary format for user off-line analysis

(e.g., CSV, TXT, FCS). Capability to generate reports summarizing processed data (the basic statistical output).

• The instrument and analysis shall be compatible with aqueous solutions over a broad pH range (at least from pH 3 to pH 12).

• The instrument and analysis shall be compatible with solutions with high concentration of additives (e.g., 0.1 % surfactants or viscosity modifiers to 1.5x water viscosity).

• Temperature control (at least 5 °C below ambient to at least 45 °C).

• User shall be able to manually adjust camera focus, camera gain, shutter speed, and frame rate.

• Sample volume of 3 mL or less needed for analysis.

• Compatible with polar organic solvents (e.g., alcohols).

• System supplied with at least two excitation sources and filters appropriate to perform fluorescent particle tracking analysis covering common fluorophores for blue and green excitation.

• Sample chamber that is disposable or compatible with cleaning solutions (e.g., ethanol, aqueous surfactants) and disinfectant solutions (e.g., bleach, 70 % alcohol solutions).

• Cost-free updates of software for at least 1 year after acquisition of the instrument.

• Measurement interrogation volume of at least 2 nL (extrapolation factor ≤ 500k to 1 mL) with the capability to analyze multiple volumes from a single sample to get better statistics on size, concentration, using syringe pump or other sampling mechanism.

• Vendor shall provide a computer system with the instrument to run data acquisition and analysis software and store acquired data.

• Vendor shall provide software for data acquisition (particle tracking) and particle sizing and concentration 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.

The Contractor shall provide one Operations and Maintenance Manual for the particle tracking analysis instrument in hard copy or electronic media in .PDF format, via email, to the

Contracting Officer’s Representative (COR).

Installation:

The Contractor shall install the instrument in Building 221, Room B325, 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 shall operate to manufacturer’s specifications upon installation. Installation shall 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 Contracting

Officer’s Representative (COR). Installation shall be completed within 60 calendar days after delivery.

Warranty:

The Contractor shall provide, at a minimum, a one-year warranty for the instrument. The warranty shall cover all parts, labor and travel. The warranty shall commence upon formal acceptance by NIST.

Training:

The Contractor shall provide training, at NIST, Gaithersburg, MD, for up to 3 NIST personnel covering normal operation, troubleshooting, and routine maintenance. Training shall 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 COR to ensure maximum availability of NIST personnel. The training may be completed on-site at NIST immediately after installation and demonstration of specifications but shall be completed no later than 30 calendar days after installation.

III. DELIVERY

Delivery shall F.O.B Destination and shall occur within 90 calendar days from award. Delivery shall occur during normal business hours, between 8:30am and 5:00pm Eastern Time, Monday through Friday, except Federal Holidays and be made to:

IV. DELIVERABLES

Description Quantity Due Date

Analytical instrument One (1) 90 calendar days after award of this requirement.

Installation of the analytical instrument Once 60 calendar days after delivery

Operations and maintenance manual for the analytical instrument

One (1) 90 calendar days after award of this requirement.

Training of NIST personnel at NIST, Gaithersburg, MD

Once 30 calendar days after installation.

V. ACCEPTANCE

Formal acceptance shall be provided by the COR after successful completion of delivery, installation, training and demonstration by the Contractor that all required specifications have been met.

VI. GENERAL INFORMATION

Safety: The Contractor employee shall be responsible for knowing and complying with NIST installation safety prevention regulations (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.

Patent Rights: The Government retains a Government use license to all inventions arising from this work.

Security: NIST is a restricted campus. An identification badge is required for access for entry into buildings and also 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 http://www-i.nist.gov/mml/safety/policies/index.htm 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 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, 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 COR and/or CO. There shall be no interviews, comments, or any other response without the knowledge and approval of the NIST

Director.