Thermogravimetric Analyzer-MIR NIR Spectrometer System w-Gas Chromatography-Mass Spectrometer

MARKET RESEARCH PURPOSES ONLY
NOT A REQUEST FOR PROPOSAL OR SOLICITATION
The U.S. Food and Drug Administration (FDA), Office of Acquisitions and Grants Services (OAGS) is issuing this source sought announcement on behalf of the National Center for Toxicological Research (NCTR) in order to determine if there are existing small business sources capable of providing a Thermogravimetric Analyzer-MIR NIR Spectrometer System w-Gas Chromatography-Mass Spectrometer.

The appropriate NAICS code for the acquisition is 334516 - Analytical Laboratory Instrument Manufacturing; Small Business Size standards - 1000 employees.

Background:

The U.S. Food and Drug Administration (FDA); Nanotechnology Core Facility (Nanocore) supports the nanotechnology needs of National Center for Toxicological Research (NCTR) and the Office of Regulatory Affairs/ Arkansas Regional Laboratory (ORA/ARL). The facility also supports studies conducted under the National Toxicology Program (NTP) and other FDA Centers. Nanocore conducts research on the characterization of nanomaterials and their biological assessment to facilitate regulatory decision-making. Nanocore also develops consensus standards in collaboration with stakeholders.

NCTR needs characterizing products/materials that either contain nanomaterial or otherwise involve the application of nanotechnology. The purchase of a Thermogravimetric Analyzer (TGA)-MIR/NIR Spectrometer system coupled with Gas Chromatography-Mass Spectrometer (GC-MS), TG-IR-GCMS, to create a multi-component system for developing analytical tools to identify the polymers present in the micro- / nano-plastics with high accuracy and reproducibility, and subsequently enhance the capabilities of Nanotechnology Core Facility.

Thermogravimetric Analyzer-MIR NIR Spectrometer System w-Gas Chromatography-Mass Spectrometer in accordance with the below General Requirements & Minimum Technical Requirements and configured as followed with all required components, connections and accessories:

1. PerkinElmer, TL 9000 Sys TGA 8000/Frontier/GCMS, material # N5320038 or equal.
2. PerkinElmer, TGA 8000 Analyzer including Autosampler, material # N5320011 or equal.
3. PerkinElmer, Clarus SQ8T MS 120/230V (EI), material # N6480012 or equal.

General Requirements:

1. The Thermogravimetric Analyzer (TGA)-MIR/NIR Spectrometer system coupled with Gas Chromatography-Mass Spectrometer (GC-MS) units shall come with all hardware, including computer, monitor, and software for the analytical measurements and data analysis. The computer hardware shall have internet, and USB port(s) and other appropriate connections for smooth overall function. The data handling shall be Windows 10 compatible.
2. All components and/or equipment shall be newly manufactured, not used/refurbished or used for previous demonstration.
3. The system shall be warranted for parts and labor for a minimum of 12 months (1-year manufacturer's warranty) from the date of installation. All warranty work shall be performed on-site at NCTR.
4. The system shall be installed by a representative from the company contracted and shall include at least 2-3 days of on-site training for familiarization of the system, optimization of basic functions and software analysis training.
5. The contractor shall include all parts, travel and labor to complete installation and training. Installation and training shall be performed during normal business hours (Monday thru Friday, 8 am to 4:30 pm, CT, excluding federal holidays).
6. The contractor shall include three references where the proposed equipment has been installed in the past year and serviced for evaluation.

Minimum Technical Requirements:

Thermogravimetric Analyzer (TGA) specifications:
1. The unit shall be integrated with temperature controller, gas controller, and autosampler (> 40 positions) system; the temperature control shall have the capability of +/- 2°C temp. change. The furnace temperature shall be tuned from sub-ambient to 1,200 °C with a heating rate varies from 0.1 °C to 500 °C/minute to address a wide range of applications.
2. The TG-unit shall be integrated with an ultra-microbalance to provide microgram resolution with high accuracy and reproducibility.
3. Shall have accessory which allows aqueous or volatile samples to be held in a sealed container vessel.
4. Shall have the ability to operate in a vacuum to 10-5 Torr.
5. For the gas control, the system shall provide two integral mass-flow controllers for balance and sample purge.
6. Built-in gas switching option shall be included.
7. It shall provide a complete control over the sample environment.
8. Shall have an anti-static device as an integral part of the system to eliminate the negative impact of static electricity on the sample and measurement.
9. The total instrument control and data analysis shall be fully operated via software. The software shall have real time calculation capability.
10. Shall be capable of connecting directly to other analytical instruments from the same manufacturer to perform simultaneous hyphenated analytical techniques, including: TG-MIR-NIR, and/or TG-GC-MS.

IR-unit specifications:
1. The system shall offer Mid and Near-IR on a common spectrometer platform.
2. The system shall include automated range switching between Mid and Near-IR measurements to further increase ease and productivity; automated range switching shall enable single button range change incorporating automatic change of source, beam splitter and detector.
3. The spectrometer shall allow the full range of MIR and Near IR to be observed without having to expose the beam splitter and internal spectrometer optics to atmosphere.
4. It shall include pre-aligned mid-IR long-life source with exclusive electronic hotspot stabilization.
5. It shall include pre-aligned tungsten-halogen NIR source.
6. The source shall be user replaceable.
7. It shall include software controlled continuously variable J-stop.
8. The System shall be a sealed and desiccated optical unit covering the range 14,700 - 350 cm-1.
9. The system shall incorporate a vibration isolated baseplate.
10. The system shall incorporate kinematically mounted, zero alignment optics.
11. The system shall include two Temperature Stabilized, fast-recovery DTGS detectors; one optimized for Mid-IR and another optimized for NIR.
12. The system shall be configurable for other detector options including a liquid nitrogen cooled MCT.
13. The system shall offer an optional external general-purpose optical bench designed for more advanced or specialized applications which would be difficult to perform using the standard sample compartment.
14. The system shall include a humidity indicator.
15. Shall include a wavenumber precision of 0.008 cm-1 at 2,000 cm-1 and wavenumber accuracy of 0.02 cm-1 at 2,000 cm-1
16. The software suite shall include the following functionality: Spectrum software - Instrument control - Basic and advanced data manipulation routines - Spectral arithmetic calculations - COMPARE spectral comparison - PLS/PCR/Beer's Law predictions - Beer's Law Quant method development - Spectrum 10 macro writer - Data tune-up - Spectral searching - Search Starter Libraries- Configurable reporting and data export - Built-in Tutorials and online Help - Laboratory scheduler - Scan and analyze.
17. Shall include automatic ready-for-work checks include contamination, noise, abscissa and throughput checks.
18. All the features of the UATR shall be included.
19. FTIR system shall be designed in such a way that the unit can be easily coupled to advanced hyphenated techniques such as TGA, GC-MS, and/or more other analytical methods.

GC-MS specifications:
1. Mass Spectrometer shall have the capability to provide EI and CI sources with full-scan (FS), SIM, and FS/SIM simultaneous within sample injection.
2. Shall include an Optional Chemical Ionization (CI) with Positive Ion Chemical Ionization (PCI) and Negative Ion Chemical Ionization (NCI) modes shall be included within the same analysis.
3. MS detector shall be either single quadrupole system or triple quadrupole system.
4. Shall have a high voltage conversion Dynode and ion filtering Pre-Quadrapoles.
5. The unit shall have option to connected with hyphenated analytical techniques such as TGA or pyrolizer. MS unit shall have capability of auto- tune, and custom tune.
6. Mass Spectrometer shall acquire spectra at (12,500 amu/sec) across every GC peak.
7. The GC-unit shall combine all the components including autosampler, column compartment (capability of holding two column).
8. Oven shall accept 1/8-in. O.D. stainless steel, 6 mm O.D. glass and all fused silica, packed or capillary columns 6.5-in. diameter coil.
9. Oven temperature range shall be programmed from -99 ˚C (with sub-ambient accessory) to 450 ˚C.
10. Carrier-gas pneumatics shall be included with injector.
11. Programmable Pneumatic Control shall provide direct setting of split-flow rates and ratios.
12. Split-vent PPC zones, automatic leak testing with PPC, and programmable split/splitless capillary injector shall be included.
13. Shall include temperature-programmable inlet with 50 ˚C to 500 ˚C in 1 ˚C increments, heat-up rate of 1 ˚C/min to 200 ˚C/min or ballistic, fast cooling rate, while the oven is cooling in the same temperature range and with an FID at 380 ˚C.
14. Gas chromatography shall offer built-in syringe autosampler for maximum sampling capabilities.
15. The unit shall support a comprehensive array of injectors that provides accuracy and precision.
16. The unit shall be built with removable glass liner for trapping nonvolatile residues, adapter for on-column injection to wide-bore capillary columns and split/splitless capillary injector option.
17. Programmable on-column capillary injector and split/splitless capillary injector shall be available in the unit.
18. Shall include touch screen graphical user interface.

Responses to this source sought shall unequivocally demonstrate the respondent is regularly manufacturing and/or selling Thermogravimetric Analyzer-MIR NIR Spectrometer System w-Gas Chromatography-Mass Spectrometer. Though the target audience is small business or small businesses capable of providing Thermogravimetric Analyzer-MIR NIR Spectrometer System w-Gas Chromatography-Mass Spectrometer from another small business, all interested parties may respond. At a minimum, responses shall include the following:

Business name and bio, DUNS number, business address, business website, business size status (i.e., SB, VOSB, SDVOSB, HUBZone SB, SDB, WOSB, LB), point of contact name, mailing address (if different from business address), phone number and email address. Provide this same information again if responding to provide a service offered by another firm.

Past Performance information shall include date of services, description, dollar value, client name, Client address, client contact name, client point of contact mailing address (if different from that provided for client), client point of contact phone number, client point of contact email address, and name of company (to include DUNS number and size status) if not the respondent.

Descriptive literature, brochures, marketing material, etc. detailing the nature of the equipment/supply item/services the responding firm is regularly engaged in manufacturing and/or selling.

The offeror shall furnish sufficient technical information necessary for the Government to conclusively determine that the offered equipment/supply item/service meet the general and minimum technical requirements identified above.

If applicable, identification of the firm's GSA Schedule contract(s) by Schedule number and SINs that are applicable to this potential requirement are also requested. If a large business, provide if subcontracting opportunities exist for small business concerns. The Government is not responsible for locating or securing any information, not identified in the response.

Interested parties shall respond with capability statements in person, by e-mail, fax, mail or other delivery method before 2:00 pm (Central Time - Local Prevailing Time in Jefferson, Arkansas) on May 29, 2019 to jennifer.johnson3@fda.hhs.gov, Fax (870) 543-7990, or mail to the U. S. Food and Drug Administration, OO/OFBA/OAGS/DAP, Attention of Jennifer L. Johnson, 3900 NCTR Rd., Bldg. 50, Rm. 429, Jefferson, AR 72079-9502 and Reference: FDA-SSN-1212020

Disclaimer and Important Notes: This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a pre‐solicitation synopsis and solicitation may be published in Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation.

Confidentiality: No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non‐proprietary technical information in any resultant solicitation(s).

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