Statement of Requirements.docx

STATEMENT OF REQUIREMENTS

Bioanalyzer

I. BACKGROUND

The Material Measurement Laboratory’s Biosystems and Biomaterials Division within the National Institute of Standards and Technology (NIST) develops and provides methods, reference materials, and reference data for characterizing biological systems. To fulfill this mission, robust characterization of cell culture samples is required. Within the Biomaterials Group, the acquisition of an automated instrument to analyze bioanalytes (metabolites and substrates) is needed to monitor cell culture health during bioprocesses. Bioanalyte analysis is critical for reproducibility of cell culture and manufacturing processes as well as characterizing cell health.

II. SPECIFICATIONS

The Contractor shall provide one (1) automated bioanalyzer instrument and consumables meeting the following specifications:

· Must be capable of analyzing cell culture substrates and metabolites;

· Must provide fully automated sample processing capabilities for up to 8 samples. Full automation means no manual manipulation after the samples, reagent and consumables have been loaded;

· Must be a bench top instrument;

· Must utilize light-based photometric measurement technology that is membrane-free;

· Must be capable of analyzing the following cell culture substrates and metabolites on a single instrument without the need of additional instrumentation, modules, or hardware:

· Glucose

· Lactate

· LDH

· Glutamate

· Glutamine

· Calcium

· Phosphate

· Total Protein

· Sodium

· Potassium

· Magnesium

· Sucrose

· Optical Density

· Galactose

· Ala-Gln

· Calculated osmolality

· Must utilize assay reagents that are lot calibrated with reagent barcoding;

· Must provide on-instrument reagent storage capabilities with reagent stability of at least 20 days;

· Must be able to configure instrument with at least 10 unique interchangeable assay sets at one time;

· Must have sample analysis throughput of up to 80 tests per hour;

· Must be compatible with single-use, disposable reaction cuvettes;

· Must have a minimum sample volume of at least 80 µl;

· Must provide at least 25ml of instrument check solutions;

· Must provide at least 5000 pieces of sample cups;

· Must provide at least 30 aluminum adapter cups;

· Must have ability to scale assays to high-throughput instrumentation.

III. DELIVERY

Delivery shall be FOB Destination and shall occur within 30 calendar days of award. Delivery shall be made to the NIST campus at 100 Bureau Drive, Gaithersburg, MD, 20899, Delivery will occur during normal business hours defined as Monday through Friday, 8:30 am to 5:00 pm, except for federal holidays.

IV. INSTALLATION

The Contractor shall install the instrument at NIST, Gaithersburg, MD within 30 days of the delivery date. Installation shall include, at a minimum, uncrating/unpacking of equipment, set-up and necessary connections for operation, instrument start-up, demonstration of instrument performance with the specifications, and removal of any trash. Installation must result in a fully functional device. Installation must take place between 8:30 AM and 5:00 PM Monday through Friday, with the exception of holidays. Installation shall be coordinated with the NIST Technical Point of Contact (TPOC).

V. TRAINING

The Contractor shall provide training at the installation site for up to two (2) NIST personnel within 30 days of installation. Training shall include instructions on how to set up the samples, choose or load protocols, clean, maintain, troubleshoot any problems, analyze, and manage the data.

VI. WARRANTY

The Contractor shall provide, at minimum, a one (1) year warranty to include all parts, labor, and travel for the instrument to keep the system operating to manufacturer's specifications and include one (1) preventative maintenance to be scheduled three weeks in advance. The warranty period shall commence upon NIST's acceptance.

VII. DELIVERABLES

VIII. ACCEPTANCE

Acceptance shall occur once the contractor installs the equipment, staff have been trained, and the system is tested by the NIST TPOC. Testing will include verifying that all measurement functions stated under section II work with one cell line and will be completed within 21 days of training.