POTS24-002392

Submitted by fratecm on
Post Date/ Solicitation Issue Date
Closing Response Date
Proposed Award Date
Project Title
Upgrade of the quality control HPLC instrument for PET drugs for human subjects, namely, Chromeleon 7.2.6 software and the Windows 7 computer.
Contracting Office
National Institute of Mental Health (NIMH)

Contact Points

Primary Contract Specialist

Tam
Ngo
ngot@nih.gov
NAICS Code Number
513210
The current software, Chromeleon 7.2.6 will be eventually obsolete, and the computer with Windows 7 operating system made in 2017 is outdated. If the computer breaks down due to aging, the recovery of the software will not be supported by the manufacturer of the quality control HPLC instrument, which will immediately stop the PET imaging drugs for human subjects. Therefore, it is desired that the software be updated, and the computer hardware be replaced before the software is completely obsolete and the 6 years old computer break down. NIMH production team have noticed that the performance of the software has been degraded recently. It is strongly recommended that the software and computer should be replaced with most up to date product. Otherwise, the continuation of the PET imaging drugs production will be greatly threatened due to the long period of restoration of the software and computer.

(1) Specify trade name; Chromeleon 7.3 workstation
(2) Specify product’s brand name; Chromeleon 7.3 workstation
(3) Specify manufacturer's name; Thermo Electron North America LLC
(4) Specify model, type, catalog, and/or part number(s): CM 7.2 to 7.3 Upgrade CM 7.3 Upgrade
Chromeleon 7.2 workstation that has been employed by PRSS of NIMH thus far satisfies the requirements of the PRSS section of NIMH.
It has the data audit capability, and compute the retention time, percent area of the peak, asymmetry, and theoretical plate. The reproducibility of these data were excellent.
The software and hardware continually worked without any major problems. Precise controls were made by the Chromeleon 7.2 workstation to produce the reproducible injection, accurate absorbance, and correct retention time. The recording of the radiation detector signal was handled by the Chromeleon 7.2 workstation. The computation of the retention time, the percent area of the peak, and other chromatographic characters were reliably measured.
The new Chromeleon 7.3 software on the new computer with Windows 10 should exceed the performance of the old Chromeleon software on Windows 7 in all computations of measured signals.
The SQL database for all previous chromatographic method and data will be copied to the new computer by the engineers from Thermo Electron North America LLC.

Description:
1. CONVERSION SE/WSO/WSS TO ENTERPRISE
2. UPGRADE 7.X TO 7.(X+1)
3. CM 7.x to 7.3 Upgrade Labor &amp
4. CM LICENSE CODE: UPGRADE
5. Win7 to Win10 Migration



Small Business Size Standard
Not Small Business
Estimated Period of Performance
The license is permanent, and NIH shall use the computer and software until the manufacturer stops supporting the current version of the software.
Delivery of Goods
30 to 60 days after receipt of order.
Competition Status
Brand Name Only
Vendor Name
Thermo Electron North America LLC
Address
Name: Thermo Electron North America LLC
Address: 1400 Northpoint Pkwy Ste 10,
West Palm Beach, FL 33407-1976
Single-Sole Source Determination
The nature of the acquisition is to sole source the software and computer hardware from the Thermo Electron North America LLC only. Thermo Electron North America LLC is the only company that makes the software that controls the HPLC pump, UV detector, and radiation detector. The software calculates chemical purity, radiochemical purity, theoretical plates, and symmetry of peak based on the raw data obtained through ThermoFisher hardware. Only the Thermo Electron North America LLC is qualified to make the software on the qualified computer machine. The only way to install and test the software from ThermoFisher 3000 is to have the qualified engineer from Thermo Electron North America LLC perform these tasks. If the acquisition is done competitively, the PET drug manufacturer, NIMH PRSS will have to suffer greatly from a long period of finding the right companies who is capable of writing the HPLC software and testing the suitability of the system, which will be beyond the scope of the NIMH PRSS. The best thing is the use the software and hardware that was already optimized for the quality control HPLC, namely, Ultimate 3000 by the manufacturer.

Background/Description of Requirement

 

The acquisition purpose is to replace the 7 years old Windows 7 computer and outdated software that is about to become obsolete with most current software on a brand new computer with Windows 10 Operating System.

 

The Thermofisher’s Chromeleon 7.2 software for Ultimate 3000 HPLC  is the most important quality control instrument for determing the identity, safety, strength, purity of the produced PET drugs. Without this instrument, the production of PET drugs for human subjects is not possible. NIMH PRSS was notified by the manufacturer that the current system would be soon obsolete and a strong suggestion for purchasing the upgraded software and computer was made by the service engineer. The manufacturer will not be obligated to support the obsolete system. If the computer and the software breaks down, NIMH PET production team face with an urgent need to purchase the system, which will increase the price of the system. Human subjects' studies will be stopped for a long period of time until the new acquisition of the computer and software is competed. The acquisition process took a long time as this will go through the COAC,and setting up the new software and migration of the established methods and data, and system suitability of testing of the software and hardware will delay significantly resuming the human subject production.   

Interested parties may identify in writing their interest and capability in response to this requirement. Responses to this notice shall contain sufficient information to establish the interested parties’ bona-fide capabilities for fulfilling the requirement and include: unit price, list price, shipping and handling costs, the delivery period after contract award, the prompt payment discount terms, the F.O.B. Point (Destination or Origin), the Dun & Bradstreet Number (DUNS), the Taxpayer Identification Number (TIN), and the certification of business size. All offerors must have an active registration in the System for Award Management (SAM) www.sam.gov.

All responses must be received by closing date and must reference the announcement. Responses may be submitted electronically to the attention of the contract specialist. Fax responses will not be accepted.

All responsible sources may submit a bid, proposal, or quotation which shall be considered by the agency.