SOW_High Resolution Mass Spectrometer with UHPLC_IRVLMP SOW.pdf

STATEMENT OF WORK

Purchase of one (1) High Resolution Quadrupole Ion Trap Mass Spectrometer with an Ultra High Performance Liquid Chromatography

System and Accessories

Background The regulatory laboratories of the Food and Drug Administration (FDA), conduct a range of chemical analyses on pharmaceutical product and dietary supplements to determine if they meet regulatory requirements. A high resolution quadrupole ion trap mass spectrometer with an ultra high performance liquid chromatography (UHPLC) system is necessary to complete regulatory work.

Purpose/Objective The purchase of one (1) high resolution quadrupole ion trap mass spectrometer with an ultra high performance liquid chromatography (UHPLC) system for the Irvine Medical Products Laboratory (IRVLMP), Irvine, CA is required to ensure the laboratory has sufficient instrumentation for the timely analysis of dietary supplements which are analyzed to detect the presence of undeclared active pharmaceutical ingredients to include GLP-1 receptor agonist ingredients.

Scope IRVLMP requires one (1) high resolution quadrupole ion trap mass spectrometer with an ultra high performance liquid chromatography (UHPLC) system and accessories that meets or exceeds the requirements below:

Requirements

I. The contractor shall provide a Orbitrap Exploris 480 mass spectrometer or equivalent. The quadrupole ion trap mass spectrophotometer shall meet or exceed the following requirements:

• The mass spectrometer must be a high-resolution, high-field bench top system that can occupy a bench space of 36 x 36 x 36 inches (h x d x w) and can connect to existing utilities to include nitrogen gas and an exhaust outlet.

• The mass spectrometer must be a quadrupole ion trap configuration.

• The mass spectrometer must have an electrodynamic ion funnel for ion transmission from atmosphere.

• The mass spectrometer must have a minimum resolution of 7500 (FWHM) at m/z 200 for all scan modes and both polarities and a maximum resolution of at least 480,000 (FWHM) at m/z 200 for all scan modes and both polarities.

• The mass spectrometer must operate in the m/z range of at least 40- 8,000.

• The mass spectrometer shall utilize accelerated Higher Collisional Dissociation (HCD) cell for generating fragment spectra.

• The mass spectrometer must be equivalent to a LC-MS/MS system utilizing a Quadrupole Mass Filter consisting of segmented mass filter, providing variable and step-less precursor isolation width selection from

0.4 Da up to 2000 Da.

• The mass spectrometer must only require nitrogen as an external gas.

• The mass spectrometer must have the following minimum sensitivity:

MS/MS: 50 fg Reserpine on column yields S/N 100:1

SIM: 50 fg Reserpine on column yields S/N 150:1

• The mass spectrometer must have the following scan speed, at a minimum:

• Highest scan rate of at least 35 Hz at resolution setting at 7,500.

• Scan speed for MS/MS is up to 22 MS/MS scans per second at resolution (R=15,000 at m/z 200) in targeted or data dependent mode

• The mass spectrometer must have the following mass accuracy, at a minimum:

• < 3 ppm RMS – with external calibration over 24 h and without any kind of mass recalibration

• < 1 ppm RMS – with internal calibration (used-defined lock mass)

• < 1 ppm RMS – with internal calibration for up to 5 consecutive days

• The mass spectrometer must be equipped with a two position RoHS valve or equivalent, to allow for solvents coming from the UHPLC to be diverted to waste.

• The instrument must include a compatible nitrogen generator.

• A compatible computer running Windows 10 or 11 OS and monitor shall be included to run software and instrument components to include the UHPLC system described in Part II.

• Software for instrument control and for data acquisition to include analysis software such as TraceFinder, Xcalibur or equivalent.

• Software such as BioPharma or equivalent, for data acquisition and analysis for protein characterization (ex. intact mass analysis, peptide mapping, oligonucleotide analysis) and to support the mass range of up to 8000 m/z.

• An uninterruptible power supply compatible with the instrument described in this document, a compatible power distribution unit (PDU) module and any necessary power cords for the specified equipment.

• The mass spectrometer must be compatible with the ultra high performance liquid chromatography system described in Part II.

II. The contractor shall provide a Vanquish Flex Binary Ultra High Performance Liquid Chromatography (UHPLC) System or equivalent. The UHPLC system shall meet or exceed the following requirements:

• The UHPLC System must be compatible with the mass spectrometer system described above in Part I.

• The UHPLC shall equipped with a binary pump with a minimum flow range of 0-5 mL/minute.

• The UHPLC shall be equipped with an autosampler to allow for split loop injection with an injection volume range of 0.010-100µl, 25µl sample loop and an accuracy of at least ±0.5%.

• The UHPLC shall be equipped with a sample compartment temperature range from 5°C to 120°C, minimally and a sample capacity of at least four racks of at least 54 vials each.

• The UHPLC shall be equipped with a column compartment thermostat capable of regulating the temperature minimally in the range of 5°C up to 120°C and the column compartment capacity allows for 2 column slots.

• The UHPLC shall be equipped with a pre-heater and post-column cooler for the column compartment.

• The UHPLC shall include necessary accessories to connect to a mass spectrometer and complete installation to include a column, syringe and syringe filters.

• The UHPLC shall be equipped with a diode array detector with at least 10 UV channels and a UV-Vis lamp.

• The UHPLC shall have a titanium flow cell with a 7mm light path length and 2.5µl volume compatible with the diode array detector described above.

Trade and Service Specifications

1. The instrument must be a newly manufactured unit, not used and refurbished or previously used for demonstration.

2. FOB Point destination to include inside delivery and clean-up of area after installation.

3. Offered systems shall be a turn-key solution i.e. the contractor shall be responsible for providing all hardware, components, instruments, computers, printers, software, and that otherwise required to meet these specifications, the FDA’s stated need, and shall be fit for intended purpose. The systems shall be delivered with all necessary supplies and accessories required for installation and start-up. The vendor shall demonstrate upon installation that the system meets or exceeds all performance specifications which have been included in the vendor’s response and/or used are evaluation criteria for award. The instrument shall not be accepted until those performance specifications have been met.

4. The entire system must be warranted for parts and labor for a minimum of 12 calendar months from the date of formal government acceptance. The vendor must also be capable of servicing the instrument through the covered warranty period. The system must include, at a minimum: coverage on all non-consumable items and parts supplied including base instrument, factory-certified replacement parts, engineer labor and travel costs. Any equipment repair and maintenance work shall be performed by an OEM-trained engineer. This factory-trained engineer shall have (verified by the OEM) the following: 1) access to OEM factory telephone support; 2) access to the most current OEM factory training for both hardware and software components;

and 3) access to all current OEM factory parts, not build-to-order parts. The OEM-trained service engineer shall not use salvaged parts from other instruments for performing maintenance and repairs. All parts used in PM and repairs must be guaranteed, factory-tested, OEM quality parts.

5. Instrument operators shall have access, for the duration of the 12 month warranty period, to a technical representative call center at no additional charge, for technical assistance and trouble-shooting, which is staffed by senior engineers to provide a high level of expertise for troubleshooting the instrument.

6. Operator level training for 2 users at the delivery onsite location shall be provided at time of installation or shortly thereafter (within 30 days), such that operators are able to independently operate the instrument and included software to conduct routine regulatory analyses on the instrument. The training shall include manuals and any consumables to be used during training.

7. The Contractor shall provide installation by a trained and certified field service engineer who shall perform the necessary verification testing to demonstrate that the instrument meets the Original Equipment Manufacturer’s operational standards following installation. Calibration solutions and consumables used for the installation shall be included.

8. 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 monthly reports to the FDA PROJECT OFFICER and Contract Specialist, not later that the 5th work day following the end of each month, summarizing all maintenance and repair activities (including warranty work) for the previous month (during months that work is performed).

9. FOB Point destination to include inside delivery and clean-up of area after installation. Installation shall be completed at each site identified in the “Delivery Location and Place of Performance” section of the SOW and shall be inclusive of all fees associates with labor, travel, and lodging.

Deliverables or Delivery Schedule

One High Resolution Quadrupole Ion Trap Mass Spectrometer with a Ultra High Liquid Chromatography System and Accessories for IRVLMP, Irvine, CA. meeting or exceeding the requirements stated above will be delivered, inside delivery required, in accordance to the following:

Description of Deliverable Qty Due Date 1 High resolution quadrupole ion trap mass spectrometer with an ultra high performance liquid chromatography (UHPLC) system and accessories

1 Delivery within 90 days after award.

2 Installation and training 1 Date to be agreed upon with the technical POC at delivery location.

No later than 30 days after award.

3 Manufacturer’s warranty of equipment, parts and operational services.

1 Begins at the completion of installation and government acceptance through one year.

Delivery Location and Place of Performance

POC: To be identified at time of award

FDA/IRVLMP

19701 Fairchild Rd.

Irvine, CA 92612

Period of Performance

The period of performance begins the date of contract award. All requirements shall be completed no later than 120 days after contract award. The equipment will include a 12 calendar month warranty period beginning the date of formal government acceptance.

Delivery will be accepted during regular business hours (Monday-Friday) during the times of 8:00 AM – 4:00 PM Pacific Time.