NB645060-25-02181 Statement of Work.pdf

STATEMENT OF WORK

Title: CO2 Incubator

NB645060-25-02181

I. BACKGROUND INFORMATION

The Applied Genetics Group is currently pursuing multiple projects requiring the tissue culture of mammalian cell lines for reference material related activities. This procurement of a new CO2 Incubator would provide needed instrumentation that would be dedicated to mammalian tissue culture projects.

II. PURPOSE

Biomolecular Measurement Division produces reference materials for biomanufacturing, such as RM 8675 (NISTCHO), a mammalian cell line that produces a monoclonal antibody (cNISTmAb). This work involves the cell culture of mammalian cells.

The new incubator is required for projects related to RM 8675 (NISTCHO). NISTCHO was released as an RGTM in 2022 and as RM 8675 in June 2025. The incubator is needed to perform stability testing (making sure the cells are still performing as expected) and to expand the cell bank internally for use by other NIST employees in related experiments.

III. SPECIFIC REQUIREMENTS

The Contractor shall provide two CO2 incubators that meets the following minimum technical requirements. The Contractor shall install the instrument and provide training as described below.

Hardware:

a) The CO₂ Incubator must be a new instrument and not a refurbished instrument.

b) The CO₂ Incubator must be able to maintain a temperature of 37 °C.

c) The CO₂ Incubator must be suitable for use in ambient laboratory conditions.

d) The CO₂ sensor technology must be an infrared (IR) sensor.

e) The CO₂ Incubator capacity must be at least 11 cu. ft.

f) The CO₂ Incubator exterior dimensions must not exceed 104 cm (width) × 66 cm (depth) × 100 cm (height) to fit into the laboratory space

g) The CO₂ Incubator must provide a CO₂ concentration range between 0 to 20% with ±0.1% accuracy

h) The heating method of the CO₂ Incubator must be direct heat.

i) The CO₂ Incubator must have a polished stainless-steel chamber.

j) The electrical requirement of the CO₂ Incubator must be 115-120 V, 50/60 Hz.

k) The CO₂ Incubator must have an integrated water reservoir for active humidity control, providing up to 95% relative humidity, with external fill and drain ports.

l) The CO₂ Incubator must have an in-chamber ISO Class 5 HEPA filtration airflow system.

m) The CO₂ Incubator must have an on-demand high-temperature sterilization cycle at either 140°C or 180°C to eliminate contamination from all internal surfaces.

n) The CO₂ Incubator must have microbiological filters on all gas inlets, outlets, and sample ports.

o) The CO₂ Incubator must have a modular microprocessor control/monitoring system with digital displays for temperature, CO₂ level, and humidity.

p) The CO₂ Incubator must have programmable tracking alarms for temperature, CO₂, and humidity deviations.

q) The CO₂ Incubator must be stackable to optimize laboratory space.

r) The CO₂ Incubator must recover CO₂, temperature, and humidity within 10 minutes after door openings

s) The CO₂ Incubator must include data logging capability or output ports for integration with laboratory monitoring systems.

t) The CO₂ Incubator must include at least four adjustable stainless-steel shelves, each supporting up to 25 kg.

u) The CO₂ Incubator must be compatible with an optional roller dolly for mobility.

IV. GENERAL REQUIREMENTS

Inspection & Acceptance:

In addition to the inspection and acceptance terms articulated in the specific FAR clause, the Government reserves the right to perform such performance tests and evaluations as defined below to verify specified system performance. Such tests and evaluations, if performed, shall be conducted within the environment that the system is to be operated. The Contractor has the right to be present during the tests and evaluations, if performed, at the Contractor’s expense.

NIST may choose at its discretion to forego this part of acceptance testing.

A visual inspection of the equipment will be performed by the NIST POC to identify surface defects or any form of indication that any equipment was damaged during transport to NIST. The Government shall have sole discretion to require repair or replacement of damaged and/or nonconforming supplies at no cost to the Government. The Government at any time prior to acceptance shall reject the equipment due to defects and/or nonconformance. The vendor is responsible for latent defects discovered any time during warranty period. However, the extent of its liability shall be prorated over the useful life of the equipment.

Ownership of the equipment shall transfer to NIST upon acceptance by the Government.

The Government will test, inspect, and accept or reject the equipment within seven (7) business days of the receipt of the equipment unless otherwise indicated above. The Government reserves the right to conduct quality assurance testing to confirm that a given instrument(s) meets the manufacturer’s and/or the Government’s performance specifications. It is anticipated that the equipment will meet all manufacturer’s specifications and/or the Government’s performance specifications identified in the most recent operations and maintenance manual for each piece of equipment and/or in this document.

Installation:

The Contractor shall install the instrument in Building 227, Room B229, 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 Subject Matter Expert (SME). Installation is to occur within 90 days of award.

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 successful completion of delivery, installation, training and demonstration of all required specifications.

Training:

Include training at NIST for up to 2 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 SME to ensure maximum availability of NIST personnel. Training is to occur within 10 days of installation. The training may be completed on-site at NIST immediately after installation and demonstration of specifications.

V. SCHEDULE OF DELIVERABLES

Description Quantity Due Date

CO2 Incubator Two (2) 60 days ARO

Installation of the CO2 incubators One (1) 90 days ARO

Operations and maintenance manual for the CO2 incubator One (1) 60 days ARO

Training of NIST personnel at NIST, Gaithersburg, MD One (1) Ten (10) days 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 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 shall provide the name and citizenship information of employees for on-site visits to the NIST SME prior to arrival. The SME 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.