SSN_ RFQ75F40125R00038_ CDER-2025-126831_Final.pdf

THIS IS A SOURCES SOUGHT ANNOUNCEMENT, A MARKET SURVEY FOR

WRITTEN INFORMATION ONLY. THIS IS NOT A SOLICITATION

ANNOUNCEMENT FOR PROPOSALS AND NO CONTRACT WILL BE AWARDED

FROM THIS ANNOUNCEMENT. NO REIMBURSEMENT WILL BE MADE FOR

ANY COSTS ASSOCIATED WITH PROVIDING INFORMATION IN RESPONSE TO

THIS ANNOUNCEMENT OR ANY FOLLOW-UP INFORMATION REQUESTS. NO

TELEPHONE CALLS WILL BE ACCEPTED REQUESTING AN RFQ PACKAGE OR

SOLICITATION. THERE IS NO RFQ PACKAGE OR SOLICITATION. IN ORDER TO

PROTECT THE PROCUREMENT INTEGRITY OF ANY FUTURE PROCUREMENT,

IF ANY, THAT MAY ARISE FROM THIS ANNOUNCEMENT, INFORMATION

REGARDING THE TECHNICAL POINT OF CONTACT WILL NOT BE GIVEN AND

NO APPOINTMENTS FOR PRESENTATIONS WILL BE MADE.

The U.S. Food and Drug Administration (FDA), Office of Acquisitions and Grants Services (OAGS) has issued this sources sought announcement on behalf of the Center for Drug Evaluation and Research (CDER)/Office of Pharmaceutical Quality (OPQ) in order to determine if there are existing small business sources capable of two (2) Thermos Scientific Exploris 120 Orbitrap Mass Spectrometers (MS) and an Ultra-High Performance Liquid Chromatograph (UHPLC) system.

If your firm is considered a small business source under North American Industry Classification System (NAICS) Code 334516 – Analytical Laboratory Instrument Manufacturing; with a Small Business Size Standard of 1000 employees and believe that your firm would be able to provide the FDA with the supplies/services described below, please submit an email to Erika.crawford@fda.hhs.gov. The vendor should include information about the company and demonstrate that it can meet all of the minimum performance requirements.

Background: The FDA Office of Pharmaceutical Quality Research (OPQR) has a need for two (2) “Brand Name” Thermo Scientific Exploris 120 Orbitrap Mass Spectrometers (Serial No.:

BRE725531) and an UHPLC (Serial No: VF:S01-A-02)system with one (1-year Post-Warranty Maintenance Option period). The Mass Spectrometers and UHPLC System are needed to support testing and research on nitrosamine impurities in drug products and substances. The Exploris 120 Orbitrap MS system can analyze compounds with a wide variety of sizes from 40 – 3000 m/z. The excellent sensitivity and resolution of this mass spectrometer will be used to identify nitrosamine drug substance related impurities (NDSRIs) by matching accurate mass measurements with calculated monoisotopic masses, and to develop fit-for-purpose methods to accurately detect and quantitate NDSRIs. Reference standards for these NDSRIs are not readily available and take on average 8 to 10 weeks to custom synthesize. Therefore, surveillance testing of drug products suspected to contain NDSRIs would take a lot of time to perform and complete. However, using an instrument like the Exploris 120 would make it faster to determine the presence or absence of these NDSRIs in suspected drug products. Thus, ordering of the required reference standards could be prioritized for subsequent verification and accurate quantitation.

https://www.thermofisher.com/order/catalog/product/BRE725531

Minimum Technical Requirements for two (2) Thermo Electron Exploris 120 Orbitrap Mass Spectrometers and an UHPLC system with one (1-year Post-Warranty Maintenance Option period):

The Mass Spectrometers shall include the following:

a. Binary high pressure mixing pumps, each with two solvent channels, capable of flow rate range 0.1 - 5000 uL/min.

b. Pumps shall be able to withstand maximum pressures of 105 MPa (~15,000 psi).

c. The solvent delivery unit shall be of parallel dual plunger micro-volume (10uL stroke construction.

• Shall include an autosampler with temperature control from 4-40 ⁰C, 162 position rack, and an external rinse pump.

• Shall include a temperature-controlled column oven with temperature control range from 10 ⁰C below ambient to 100 ⁰C. Column oven should accommodate columns up to 300 mm in length.The Contractor shall ensure compatibility of operation, including system communication and hardware configuration, between the liquid chromatograph and mass spectrometer.

• The contractor shall provide 30-day notice prior to shipping. All reports for installation and qualification shall be provided (electronic format preferred). Acceptance will be made by the government within 30 days following completion of instrument installation and qualification

Exploris 120 Orbitrap Mass Spectrometer

• Mass Range shall be between 40-300 m/z

• Mass Analyzer Resolution shall be up to 120,000 at 200 m/z

• Scan Rate shall be up to 120,000 at 200 m/z

• Mass Accuracy shall include an external calibration achieves <3 ppm RMS drift over 24 hours;

1-point calibration achieves <3 ppm RMS drift over at least 4 weeks; an Internal lock mass calibration achieves <1 ppm RMS drift over 24 hours; and an EASY-IC that achieves <1 ppm RMS drift for at least 5 days.

• Instrument Detection Limit shall include Full Scan: < 3.0 fg reserpine on column tMS2: < 3.0 fg reserpine on column; and tSIM: < 1.5 fg reserpine on column

• Sensitivity shall include MS/MS: 200 fg reserpine on column, S/N 100:1; and a tSIM: 200 fg reserpine on column, S/N 250:1

• Dynamic range* shall be greater that >5,000 within a single Orbitrap mass analyzer spectrum

• Polarity Switching shall include One Full Scan cycle** <700 ms equals >1.4 Hz; and One tSIM Scan cycle** <600 ms equals >1.6 HzMultiplexing shall be up to 20 precursor ions per scan in tMS2 and up to 20 compounds per scan for tS

• Analog inputs shall be channel 1 analog input (±10 V), Channel 2 analog input (±10 V)

• Warranty shall include coverage for all parts after shipment and installation for at least 1 year.

* Under defined conditions

** One cycle consists of acquiring one Full Scan in positive mode and one Full Scan in negative mode at resolution setting 60,000 one tSIM Scan in positive mode and one tSIM Scan in negative mode at resolution setting 60,000

Vanquish Ultra-High Performance Liquid Chromatography (UHPLC) (Serial No.: VF-S01- A-02) Specifications:

• Software - All units shall be compatible with the currently available Orbitrap MS Series Instrument Control Software, Xcalibur software or Thermo Scientific™ Chromeleon™ Chromatography Data System (CDS).shall be compatible with the currently available Orbitrap MS Series Instrument Control Software, Xcalibur software or Thermo Scientific™ Chromeleon™ Chromatography Data System (CDS).

• Vanquish Binary Pump H (Serial No.: VH-P10-A-02) shall include (1) Flow range from

0.001 to 5 mL/min, in 1 µL/min increments (Flow accuracy of ± 0.1%); (2) Built-in solvent degassing; at least 2 channels; and (3) Pressure range of 50 to 1517 bar.

• Split Sampler HT (Serial No.: VH-A10-A-02) shall include (1). Sample temp control must cover 4 – 40 °C (temperature stability of ± 1 °C); (2). Injection volume settings must cover 0.01-100 μL, default 25 μL sample loop shall be installed. (3). Injection volume precision of <0.25% area RSD for 1 μL (caffeine in water); and (4) Must hold at least 216 of 1.5 mL HPLC vials.

• Column Compartment H (Serial No.: VH-C10-A-03) shall include (1) Must have temperature range of 5 to 120 °C (temperature accuracy of ± 0.5 °C up to 80 °C); (2) Pressure range of 50 – 1517 bar; (3) At least 2 column slots with a column switching valve.

https://www.thermofisher.com/order/catalog/product/IQLAAAGABHFAPUMBJC https://www.thermofisher.com/order/catalog/product/IQLAAAGABHFAPUMBJC https://www.thermofisher.com/order/catalog/product/VH-P10-A-02 https://www.thermofisher.com/order/catalog/product/VH-A10-A-02 https://www.thermofisher.com/order/catalog/product/VH-C10-A-03

• Diode Array Detector FG (Serial No.: VF-D11-A-01) shall include (1) Detector data collection rate of up to 250 Hz; (2) Must have a wavelength accuracy of ± 1 nm with a range of 190 – 800 nm and a settable slit width (wide, narrow); and (3) Must have a drift of less than 1 mAU/hour at 254 nm and noise of less than ± 6 µAU at 254 nm (standard flow cell, bandwidth: 4 nm, slit width: wide, time constant: 2 sec.).

• Computer shall be an instrument control computer with Win 10 installed, must be compatible with the currently available Orbitrap MS Series Instrument Control Software, Xcalibur software and Thermo Scientific™ Chromeleon™ Chromatography Data System

(CDS).

Installation, Training and Warranty Requirements:

• The system and its associated accessories shall include operations and maintenance manuals covering proper operation, routine maintenance, and troubleshooting for the instrument and controlling software. All manuals and documentation on the instrument shall be provided in hard copy and/or electronic format.

• Offered systems shall be a turn-key solution i.e., the contractor shall be responsible for providing all hardware, components, instruments, computers, software, and that otherwise required to meet these specifications and the FDA’s stated need.

• The systems shall be delivered with all necessary supplies and accessories required for installation and start-up.

• The offeror shall provide installation and operational qualification (IQ/OQ) 90 days after award.

• The offeror shall verity that the software installed in the Win 10 computer is fully functional for instrument control and data analysis in an IQ/OQ report.

• The offeror shall be responsible for the installation of the Orbitrap MS Series Instrument Control Software, Xcalibur software, Thermo Scientific™ Chromeleon™ Chromatography Data System (CDS) and all required drivers to this Win 10 computer.

• The offeror shall provide software/hardware familiarization for 3-4 scientists at the place of instrument performance (OPQR-St. Louis).

• The Contractor shall install the equipment and provide all labor, travel, kits and tools, etc, to install the equipment at the address provided below, to include inside delivery.

https://www.thermofisher.com/order/catalog/product/VF-D11-A-01?SID=srch-hj-VF-D11-A-01

• The Contractor shall demonstrate upon installation that the item meets or exceeds all performance specifications. Upon acceptance of the system, the contractor shall provide on-site operator training/familiarization for one day 60 days after installation. Such familiarization shall include system operations, calibration, optimization, troubleshooting and basic operational maintenance procedures.

• System shall be warranted for not less than one (1) year from FDA acceptance of the system(s) to include on-site training. Warranty service shall include troubleshooting capabilities based on complete knowledge of the entire system, immediate access to replacement parts, and immediate access to system improvements and updates; unlimited telephone/e-mail support for questions regarding operation, onsite visits for diagnosis of problems and repairs inclusive of all parts, labor, and travel expenses at no additional cost to the FDA.

Minimum Performance Requirements for one (1-year Post Warranty Maintenance Option Period):

• The Contractor shall provide one (1) scheduled on-site planned preventive maintenance visit per year.

• The Contractor shall provide unlimited On-Site Corrective Maintenance/Repairs within 3 business days of call for service where problems cannot be resolved remotely after 2 business days.

• The Maintenance and Repair activities shall be performed following the Original Equipment

Manufacturer (OEM) specifications, manuals, and service bulletins, using OEM-certified replacement parts, components, subassemblies, etc.

• The Contractor shall include unlimited software and firmware updates during the coverage period(s).

• The Contractor shall include unlimited technical support Monday through Friday (excluding Federal Holidays) 8:00AM – 5:00PM Eastern Time.

• All maintenance/repair pricing shall be inclusive of labor, travel, replacement parts, components, subassemblies, etc.

Estimated Delivery Date: 90 days after award.

Option Year 1: 10/18/2026 thru 10/17/2027

Delivery Location:

Food and Drug Administration Center for Drug Evaluation and Research CDER/OPQ/OPQR – St. Louis 645 S. Newstead Ave.

Saint Louis, MO 63110

Service Records and Reports The Contractor shall, commensurate with the completion of each service call (inclusive of warranty service), provide the end-user of the equipment with a copy of a field service report/ticket identifying the equipment name, manufacturer, model number, and serial number of the equipment being serviced/repaired and detailing the reason for the service call, a detailed description of the work performed, the test instruments or other equipment used to affect the repair or otherwise perform the service, the name(s) and contact information of the technician who performed the repair/service, and for information purposes, the on-site hours expended and parts/components replaced. In addition, the Contractor shall provide a written report to the FDA Technical Representative and Contract Specialist, summarizing all maintenance and repair activities (including warranty work) each time service and/or repair is performed.

Special Requirements;

• Security: Supervision of install engineer upon arrival at the FDA’s facility will be required.

All software required must be approved on FDA’s Master Approved Technology (MAT) list and comply with OIMT requirements. Software not already on the FDA MAT list may be considered but must be approved on MAT list prior to award.

Requested Information:

Please provide the following information:

• Company's name, mailing address, Cage Code, and Unique Entity Identifier (UEI).

• Recommended North American Industry Classification System (NAICS) code that your company utilizes for in support of the following equipment: Two (2) “Brand Name” Thermo Fisher Scientific Exploris 120 Orbitrap Mass Spectrometers and a UHPLC system

• What is your company size? If small, what is your socio-economic status?

• Identify any GSA Schedule contract or other current government-wide contract (e.g., GWAC or BPA) that your company currently holds and offers these products/services under.

• Domestic manufacturing status.

• Technical specifications for the proposed solution.

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 sam.gov. However, responses to this notice will not be considered adequate responses to a solicitation.

A standard capability flyer or brochure submission will not be considered responsive or sufficient to this Sources Sought Notification (SSN). Respondents to this SSN may be requested to provide additional information/details based on initial submittals. The Government reserves the right to select one (1), some, or none of the submissions for further information. Firms who submit information in response to this SSN do so with the understanding that U.S. Government personnel may review their materials and or data.

The FDA reserves the right to set this action aside for small business if it determines that there are two or more small business capable of performing the services and meeting the terms of market prices, quality, and schedule. If set aside, a small business will be required to perform at least 50% of the direct labor costs incurred under the contract. Responses from small business must address their ability to sufficiently meet this requirement.

The Government will not reimburse respondents for any costs associated with information submitted in response to the SSN. Responders are solely responsible for all expenses associated with responding to this SSN.

Responses to this SSN are not offers and cannot be accepted by the Government for the basis of forming a binding contract. This SSN is being issued solely for the purpose of gathering information for planning purposes. This SSN does not commit the Government to a contract for any supply or service. Furthermore, the Government is not at this time seeking proposals or quotations and will not accept unsolicited offers/quotes.

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).

Additional Notes:

If the stated requirements appear restrictive, please submit comments detailing the concern.

Though this is not a request for quote, informational pricing for the service would be helpful.

Response Deadline:

Interested Contractors must respond with capability statements via email to the point of contact listed below on or before January 28, 2025, by 10:00AM hours (Eastern Time) at the Food and Drug Administration, Facilities Support Branch, FDA|OO|OFBA|OAGS|DAP, Attn: Erika Crawford, email Erika.crawford@fda.hhs.gov. Reference: 75F40125R00038. Questions regarding this SSN must be submitted via email as telephone inquiries will NOT be addressed and shall NOT contain proprietary or classified information.