Final SOR- process Raman spectrometer.pdf

STATEMENT OF REQUIREMENT

TITLE: Procurement of a process Raman spectrometer

I. BACKGROUND INFORMATION

II.

The Biomolecular Structure and Function (BSF) group in the Biomolecular Measurement Division of the Materials Measurement Laboratory at the National Institute of Standards and Technology

(NIST) (1) advances novel measurement methods and models for the determination and analysis of the structure and function of biological macromolecules, including lipids, DNA, RNA, and proteins and macromolecular complexes and assemblies formed by these molecules; (2) advances methods to determine the physical and chemical factors which determine the specific interactions of macromolecules with cofactors and ligands; (3) studies the relationships between biomolecule structure, dynamics, function, and energetics using computational, biophysical and biochemical techniques; (4) develops reference databases for these properties; and (5) advances measurement methods for engineering complex biological systems.

In support of this mission, the BSF group is establishing a biomanufacturing testbed for representative processes used during the production of therapeutic proteins. To support this work, the group requires capabilities to perform rapid in-line upstream and on-line downstream Raman measurements of mammalian cell cultures and protein biologics.

III. SPECIFICATIONS

The Contractor shall deliver, install and provide training for one (1) process Raman spectrometer instrument meeting all specifications below. The Contractor shall deliver instrument consumables as specified below:

• The instrument must be based on a 785 nm laser

• Instrument must be compatible with Ambr bioreactors

• The instrument must be compatible with Ambr software controls by either an integrated controller or by a connected computer and automated so that all measurements can be performed using defined protocols with no manual interventions required during normal operation.

• The instrument must provide laser powers between 20mW and 490mW

• The instrument spectral range must cover 200 cm-1 to 3300 cm-1 Raman shift from 785 nm

• The instrument must be capable of a resolution better than 5 cm-1

• The instrument must be capable of a 0.1 cm-1 wavenumber stability

• The instrument must have a precalibration dynamic range of 45,000 counts

• The instrument must include defined protocols for calibration and/or quality control of all measured parameters to within manufacturer-specified tolerances.

• The instrument must include the option to switch between four channels or probes in different bioprocessing vessels.

• The instrument must be able to measure samples of mammalian cell cultures containing suspended cells.

• The instrument must have automated system health monitoring and fault detection

• The instrument must measure protein concentration

• The instrument must measure glucose concentration

• The instrument must measure lactate concentration

• The instrument must measure other amino acid concentrations

• The instrument must measure pH

• The instrument must measure viable cell density

• The instrument must measure cell viability

• The instrument must measure aggregate concentration

• The instrument must measure glycosylation

• The instrument must detect “break though” or overloading of column capacity

• The instrument must be capable of tangential flow filtration monitoring

• The instrument must be capable of automated data monitoring, analysis and reporting for measured parameters.

• 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

Government acceptance.

General Software Requirements:

If the use of manufacturer-specific or proprietary software is necessary for offline review of measured data or for exporting of measured data to a plaintext format, such as comma separated values (.csv), the Contractor must include one (1) copy of such software compatible with installation on a NIST-provided Windows-10/11 based personal computer (PC).

Required Consumables:

• Calibration kit including Hg-Ar source and white light source

• Fiber optic cables

• Fiber optic maintenance kit and probe tip cleaner

Manuals:

• The Contractor must provide at least one copy of manual(s) for user operation and maintenance of the instrument in either electronic or hard copy format.

Installation:

The Contractor shall install the instrument at NIST/IBBR in Rockville, 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 will take place during NIST 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 occur within 60 calendar days of delivery.

Warranty: The Contractor shall provide an initial one (1) year warranty for the equipment. The warranty shall cover all parts and labor (including field service labor and travel required to restore the equipment to normal operation.) The warranty shall cover new replacement parts that function equally to originals. The warranty shall also cover the software, and that the software will perform in compliance with the written materials accompanying the software. The warranty shall commence upon Government acceptance.

Training:

The Contractor shall provide in person training at NIST/IBBR 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 or Subject Matter Expert

(SME) to ensure maximum availability of NIST personnel. Training shall occur within 30 calendar days of installation. The training may be completed on-site at NIST immediately after installation and demonstration of specifications.

IV. DELIVERY

Delivery terms shall be FOB Destination and shall be accomplished at NIST/IBBR, Rockville, Maryland. Delivery shall occur during NIST Normal duty hours Monday through Friday, 8:30 a.m. to 5:00 p.m. with the exception of Federal holidays, and will be coordinated with the NIST

COR. Delivery shall occur within 120 calendar days of award.

V. DELIVERABLES

Description Quantity Recipient Due Date process Raman spectrometer One (1) system

COR 120 calendar days after award

Software for offline data review and/or export, if required

One (1) copy

COR 120 calendar days after award

Consumable Kit One (1) COR 60 calendar days after delivery

Installation of the process Raman spectrometer Once

COR 60 calendar days after delivery

Operations and maintenance manual for the measurement system

(in either electronic or hard-copy format)

One (1) set

COR

120 calendar days after award

Training of NIST personnel at

NIST/IBBR, Rockville, MD Once

COR 30 calendar days after installation

VI. ACCEPTANCE CRITERIA

Formal acceptance shall be given by the Government when the Contractor demonstrates that all specifications in this statement of requirement have been met (inclusive of delivery, installation, and training).

VII. 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/IBBR is a restricted campus. An identification badge is required for access for entry into buildings and may be obtained from the security desk upon arrival.

Identification Badges: Contractor employees shall comply with NIST/IBBR identification and access requirements. The Contractor shall provide the name and citizenship information of employees for on-site visits to the COR prior to arrival. The 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, proof of insurance, and current registration must be presented to the NIST Security Office.