Statement of Requirement (Final).pdf

STATEMENT OF REQUIREMENT

TITLE: Procurement of Analytical Ultracentrifuge Instrument

I. BACKGROUND INFORMATION

The Material Measurement Laboratory’s Bioprocess Measurements Group is involved in the manufacture, measurement, and manipulation of various colloidal particles of biological, engineered biological, or synthetic origin. These activities have applications in understanding and quantifying the safety, efficacy, consistency, composition, and activity of these colloidal particles in support of the division’s biomanufacturing program.

In order to accomplish this understanding and quantification, NIST needs analytical instrumentation that facilitates the following:

1. size-based separation of colloidal nanoscale materials

2. determination of particle sedimentation coefficients

3. size-based separation in native, matrix-free conditions

4. measurement of aggregates [multiple colloidal particles that have coalesced through any mechanism] in various formulations

5. determination of molar mass of colloidal particles

6. calculation of particle number concentration for each particle size

A suitable technology to accomplish these measurement requirements is an analytical ultracentrifugation (AUC) with integrated multi-wavelength ultraviolet-visible and interference detectors.

II. SPECIFICATIONS

1. HARDWARE

The Contractor shall provide one analytical ultracentrifuge (AUC) instrument, the Beckman

Coulter Optima AUC, that includes the following detectors and/or features. The hardware will consist of an automated, computer-controlled ultracentrifugation system that:

1. Separates particles based on mass and/or density.

2. Includes online absorbance detector.

3. Includes online interference detector.

4. Includes a single four-cell rotor that can achieve speeds up to a maximum of 290,000 g

5. All required equipment to assemble and load cells into the centrifuge including all gaskets, spectroscopic windows, counterbalancing cell, and cell assembly tools to operate all sample cells simultaneously (sufficient supplies for all samples cell without sharing between sample cells.

6. Controls temperature in a spatially and sufficiently uniform manner over an analysis cycle of all samples in the chamber from 4°C to 40 °C to prevent any spurious density gradient inversions from non-uniform temperature spatial distribution.

7. Equipped with a CCD camera for recordation of spectroscopic data.

The specifications define this unit to be an analytical ultracentrifuge unit including the functionalities as defined below:

Detectors:

• Online absorbance detector must have wavelength resolution of +/- 0.5 nm or better

• Online absorbance detector must have a minimum wavelength range of 190 nm to 800 nm

• Absorbance detector should have multi-wavelength capabilities of measuring at least 10 wavelengths simultaneously

• CCD camera has a size of 2048 pixels 1088 pixels or larger

• Interference detector has ≥ 10 fringes/cell

• Absorbance detector must be able to go down to a minimum of 0.005 absorbance units, roughly corresponding to a concentration of bovine serum albumin (BSA) ~ 1 mg/mL to

2 mg/mL

• Interference detector must be able to measure down to ~ 4 mg/mL to 5 mg/mL (BSA)

Rotor:

• Rotor must be able to contain at least three analytical samples as well as a counterbalance

• Rotor must be able to achieve 262,000 g force at cell center during separation runs

Instrument Manuals and Maintenance Procedures:

• Standard manufacture instrument manuals in hard copy or electronic PDF format o Include basic instrument operations and user-based maintenance procedures o Include standard procedures for data analysis with contractor-supplied software.

2. SOFTWARE

The Contractor shall include software for automated data acquisition and automated control of the analytical ultracentrifuge instrument suite, including the detectors listed above and capable of calculating sedimentation coefficients, molar mass, and particle number concentration from acquired data.

3. OPTIONS: PROTECTIVE POST-WARRANTY PLAN (Option Year 1-Option Year

4)

The Contractor shall include four (4) years of the Beckman Coulter “Protective Post-Warranty

Plan”, in one (1) year increments, to cover the instrument after the expiration of the initial 12-month warranty and service included with the instrument purchase. The service maintenance/warranty shall cover the cost of all certified parts, labor and travel, required to restore the instrument to normal operation. It shall also include:

• One (1) annual on-site preventive maintenance visit

• One (1) annual health check

• Software and engineering updates as needed.

• Unlimited remote technical support

• Annual basic operator training

4. INSTALLATION

The Contractor shall install the instrument. All installation work shall be accomplished at NIST, 9600 Gudelsky Dr, Rockville, Maryland. 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 occur during normal business hours, between 8:30am and 5:00pm Eastern Time, Monday through Friday, except Federal

Holidays, and shall be coordinated with the NIST Contracting Officer’s Representative (COR).

Installation shall occur within 10 calendar days from delivery of instrument.

5. TRAINING

The Contractor shall provide an in-person training for up to three (3) NIST personnel. The training session shall include, at a minimum: a demonstration of all basic operation, calibration, and routine maintenance procedures. Training shall occur during normal business hours, between

8:30am and 5:00pm Eastern Time, Monday through Friday, except Federal Holidays, and shall be coordinated with the COR. Training shall occur within 10 calendar days from installation and may commence immediately upon successful completion of installation and successful demonstration of specifications.

III. DELIVERY

Delivery shall be 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:

National Institute of Standards and Technology

9600 Gudelsky Dr, Rockville MD 20850

FOB Destination means: The contractor shall pack and mark the shipment in conformance with carrier requirements, deliver the shipment in good order and condition to the point of delivery specified in the purchase order, be responsible for any loss of and/or damage to the goods occurring before receipt and acceptance of the shipment by the consignee at the delivery point specified in the purchase order; and pay all charges to the specified point of delivery.

IV. DELIVERABLES

Description Quantity Due Date

Analytical Ultracentrifuge Instrument Suite One No later than 60 calendar days from award

Instrument Manuals and Maintenance

Procedures, in PDF or paper hard copy

One No later than 60 calendar days from award

Installation once No later than 10 calendar days from delivery

Description Quantity Due Date

Basic On-site Training Three people

No later than 10 calendar days from delivery

Initial Warranty 1 Year To commence upon

Government acceptance of instrument

Option Year 1- “Protective Post-Warranty

Service” Extended warranty

1 Year To commence upon

Governments exercise of option.

Option Year 2- “Protective Post-Warranty

Service” Extended warranty

1 Year To commence upon

Governments exercise of option.

Option Year 3- “Protective Post-Warranty

Service” Extended warranty

1 Year To commence upon

Governments exercise of option.

Option Year 4- “Protective Post-Warranty

Service” Extended warranty

1 Year To commence upon

Governments exercise of option.

V. ACCEPTANCE CRITERIA

The Contractor shall demonstrate that all performance specifications are met after installation.

VI. GENERAL INFORMATION

Safety: The Contractor employee shall be responsible for knowing and complying with commercial installation safety prevention regulations. 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 must be shown to the armed Security Police when entering the campus.

Identification Badges: Contractor employees shall comply with NIST identification and access requirements. The Contractor shall provide the name and citizenship information of employees for on-site visits to the NIST Subject Matter Expert (SME) and Contracting Officer’s

Representative (COR) prior to arrival. The SME or COR will submit the name(s) and citizenship information to the NIST Office of Security in order for a given Contractor employee to enter the

NIST campus. The Contractor employee is responsible for absences due to missing or expired identification and access documents. Each Contractor employee shall wear a visible identification badge provided by the NIST Security Office.

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 (which in most cases can be a valid driver's license), proof of insurance and current registration must be presented to the NIST Security Office.