PD Compact HPLC 04-2020(official).pdf

Version 11-30-2016-1 FAR Part 11—Describing Agency Needs

PURCHASE DESCRIPTION

1. Statement of Need and Purpose: The National Institute of Mental Health (NIMH), Molecular Imaging Branch (MIB) requires two (2) compact High-Performance Liquid Chromatography (HPLC) systems for the purpose of purification and quality control of PET radiopharmaceuticals and supporting research and development work.

2. Background Information and Objective: The PET Radiopharmaceutical Sciences Section (PRSS) of the NIMH requires the purchase of two (2) compact HPLC systems for purification and analysis of PET radioligands in our radiochemistry facility. PRSS is currently in the process of renovating our laboratory space to install two new lead-shielded hot cells to increase our capacity for PET methodology development and radioligand production for animal studies. Each hot cell will require one complete semi-preparative scale HPLC system to purify the radiolabeled compounds.

3. Generic Name of Product: Compact High-Performance Liquid Chromatography (HPLC) System

4. Purchase Description: Knauer Azura HPLC System that includes all of the following parts:

a. UVD 2.15 Variable wavelength UV detector

b. Flow cell, 10 µL

c. P 2.15 compact HPLC pumps (two per system)

d. Dynamic mixing chamber

e. Colibrick A-D 2-channel converter

f. ClarityChrom software

g. All additional accessories required for operation of the complete system

5. Salient characteristics

a. The HPLC System shall have a variable wavelength detector which shall meet the following specifications:

i. The physical size of the UV detector unit shall be smaller than 5”x9” to fit within the existing available space and comply with radiation safety requirements.

ii. An operator of this PDA detector shall be able to select a UV wavelength from c.a. 190 nm to c.a. 450 nm.

iii. UV detector unit must be able to function efficiently when physically separated from the rest of the system.

iv. Flow cell shall be replaced easily when damaged.

v. The controlling PC shall have electronic communication via either RS323 or LAN (Ethernet) or USB communication to the PDA detector and pumps device.

vi. The standard deviation of the baseline, namely, noise level shall be below ± 1x10-3 AU at 254 nm.

b. The HPLC system shall have an analog to digital converter that logs data into hard disk drive in addition to UV absorbance signal selected from PDA. More specifically, the system shall provide an analog to digital converter to handle voltage signal ranging from 0 to 10 V coming from the existing radiation detector (Bioscan Flow-Count).

i. The analog to digital converter shall have at least 12-bit resolution.

ii. The sampling rate of the analog to digital converter shall be greater than

10 Hz. The sampling rate here includes the rate of the writing the data into the hard disk drive (non-volatile memory).

iii. In addition to UV chromatogram, this additional signal from the radiation detector shall be plotted in the separate charting windows. Alternatively, the same chart shall be able to display UV and radiation signal simultaneously.

iv. The software shall be able to scale UV and radiation signal automatically such that the maximum of the biggest peak can be seen during the requisition of data.

v. One shall be able to select either UV or additional analog signal of the previous chromatogram and shall be able to overlay the data while data is being plotted on a charting window.

vi. One shall able to scale the horizontal axis (x-axis for time) and the vertical axis (y-axis for UV absorbance or radiation) automatically such that the entire data is visible in the charting window during real time data acquisition.

c. The HPLC System shall have 2 HPLC Pumps per system which shall meet the following specifications:

i. Flow rate shall range between 0 and 10 milliliters per minute (mL/min).

ii. Flow rate shall have the accuracy of +/- 1% at approximately 2 mL/min.

iii. All fittings and tubing necessary to plumb the system shall be included.

iv. The pump shall be able to handle the back pressure up to 5 kpsi.

v. The pump shall have a built-in pressure sensor with settable upper and lower limits to monitor the performance of the system.

vi. The HPLC pump shall be able to minimize pulsation by providing a mechanical solution such as pulse dampener.

vii. The HPLC pump system shall use two pumps to change the mobile phase gradually and systematically. The pumps shall be computer controlled to yield reproducible results.

viii. The HPLC pump system shall have a mixing mechanism of mobile phases.

d. The software shall allow the user to create project-specific folders, methods, data files, and customizable reports, as well as allow customized integration tools and control of components by manual intervention as well as pre-programmed method.

e. Delivery and Installation shall be performed by the offeror. Upon delivery the vendor shall install the equipment and perform an equipment function test in the presence of a NIMH radiochemist to ensure the equipment is fully functional.

f. The offeror shall provide equipment training for a minimum of one day, including software operation, to NIMH radiochemists.

6. Quantity: Two complete systems

7. Delivery Date: Delivery shall be arranged between the vendor and the project officer once the order is complete and routine laboratory operations at the NIH have resumed following the COVID-19 restrictions

8. Other Considerations: Systems shall be covered under a 1-year warranty to include service and replacement parts.