Statement of Requirements.pdf

STATEMENT OF REQUIREMENTS

Specialized Upright Microscope Platform

I. BACKGROUND INFORMATION

The goal of the gene therapy manufacturing innovations in measurement sciences (IMS) project, within the Biosystems and Biomaterials Division, Material Measurement Laboratory, is to develop light scattering microscopy methods to characterize gene delivery particles. Emerging gene therapy treatments use gene delivery nanoparticles, such as viral vectors and non-viral carriers, to cure intractable diseases. These manufactured particles suffer heterogeneity issues that hinder treatment efficacy and safety. This project aims to develop light-scattering microscopy methods to enable rapid, multi-attribute measurements of individual gene therapy nanoparticles’ physical characteristics. Such measurements will speed the development of new gene therapy treatments and improve their efficacy and safety.

Essential to this work, the division will need to build a custom multispectral light scattering imaging system that can be compared with traditional microscopy modes of reflection fluorescence and bright field microscopy. A new electrophysiological-style upright microscopy platform is required that can perform both fluorescence and bright field microscopy and that has a large breadboard platform stage for attachment of an end-user customized prism-based light scatter illumination system.

II. SPECIFICATIONS

The Contractor shall provide one (1) electrophysiological-style upright microscope that meets the following minimum technical requirements. The Contractor shall install the instrument and provide training as described below.

System Requirements

Microscope Body

• Microscope frame must be upright vibrational stable Y-shaped body of approximately 19 kg.

• Microscope stand must have front located fine/coarse focus.

• Microscope must have a swing out nosepiece with vibration-free counter-spring mechanism.

• Microscope must have a swing out condenser with N.A. of 0.90.

• Microscope body must have built-in Kohler illumination for transmitted light.

• Must have a trinocular tube with 10x eyepiece.

Sample Platform with XY Motorized Stage

• Must have a sample platform compatible with the microscope body with 4 pneumatic piston towers for support and motorized XY stage.

• Must have an XY travel distance of at least 65 mm x 65 mm, with a speed of up to 15 mm/sec, and a XY resolution of 40 nm or better.

• Must have a large top plate surface with breadboard screw holes for mounting additional custom instrumentation.

• Must have a controller, joystick, and computer control interface.

Z-piezo Objective Positioner

• Must have a z-piezo nanopositioning objective scanner for upright microscope body that has a travel distance of at least 400 mm.

• Must have a resolution of 0.7 nm or better and a step settle time of 7 ms or better.

Reflection Fluorescence Illumination

• The system must include a reflected light illumination module for wide-field fluorescence microscopy. The system must have a six-position turret with filter sets provided for DAPI, EGFP, MCHERRY, and brightfield.

• The system must include an LED illumination source with 8 wavelengths of nominal wavelength: 400, 435, 470, 500, 550, 580, 635, and 740 nm. The illumination light engine must efficiently combine the output of 8 LEDs into a single liquid light guide.

• The illumination source must include a software package and connection via USB to a Windows 10 PC.

• The software must be able to set the intensity of each LED individually as well as simultaneously.

Reflection Brightfield Illumination

• Microscope must have a white light LED module for reflection mode brightfield.

sCMOS camera

• Microscope must have a monochrome back-illuminated scientific CMOS sensor with 4416 pixel x 2368 pixel resolution or better.

• sCMOS camera must have a pixel size of 4.6 mm or smaller, a peak quantum efficiency of 85% or greater, a readout noise of 0.7e- or lower, and a frame rate of 122 fps or better.

• The camera must include a software control package and a camera link HS (CLHS) connection.

• The camera must be compatible with water cooling, and the camera must come with a water-cooling system.

Imaging Objectives

• The microscope must include a water dipping objective with NA 1.2 and two long working distance water dipping objectives of NA 0.3 and NA 1.1.

• The microscope must include an oil immersion objective of NA 1.45.

• The microscope must include air objectives with NA 0.25 and NA 0.60.

Manual and Software

• The system must include an operation manual (hard copy or electronic)

III. INSTALLATION

The Contractor shall install the instrument in Building 227, Room B251, at NIST Gaithersburg, MD.

Installation shall include, at a minimum, uncrating/unpacking of all equipment, set-up and assembly of all equipment, start-up, demonstration of specifications, and removal of all trash. Instrument will 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 Contract Officer Representative (COR) Installation is to occur within 10 days of delivery.

IV. WARRANTY

The Contractor shall provide, at a minimum, a one (1) year warranty for the equipment. The warranty shall cover all parts, labor and travel. The warranty shall commence upon acceptance by the Government.

V. TRAINING

The contractor shall provide training at NIST for up to two (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 COR to ensure maximum availability of NIST personnel. Training is to occur within 10 business days of installation. Training may be completed on-site at NIST immediately after installation and demonstration of specifications.

VI. DELIVERY

The instrument shall be delivered to NIST Gaithersburg, MD Building 227, Room B251, between the hours of 8:30AM to 5:00pm Monday through Friday except Federal Holidays within 90 days of award.

VII. DELIVERABLES

Description Quantit y Due Date Microscope platform One (1) 90 calendar days after award of this requirement.

Installation of the microscope platform Once 10 business days after delivery Operations and maintenance manual for the microscope platform

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

Training of NIST personnel at NIST, Gaithersburg, MD

Once 10 business days after installation.

VIII. ACCEPTANCE CRITERIA

The Contractor shall demonstrate that all performance specifications are met.

IX. 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 prior to arrival. The TPOC 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.