Description
B-2 Statement of Work The system will be used for forensic sample analysis of drugs, foods, and dietary supplements. LC/MSn instruments provide relatively fast, accurate, and dependable identification of drugs of abuse such as fentanyl, fentanyl analogs, and other opioids and may also be used to detect and identify designer opioid analogs. Additionally, this system will be used to detect drugs and toxins in adulteration and product tampering cases involving foods, drugs and dietary supplements. Furthermore, the Food Emergency Response Network (FERN) LC-MS chemical terrorism (CT) poison screen is performed using this type of instrument. Order Type FDA intends to award a single firm-fixed-price order for the items described below. SCOPE The Forensic Chemistry Center (ORA/ORS/OMPTSLO/FCC) requires the purchase of One (1) Ultra-High Performance Liquid Chromatography - Ion Trap Mass Spectrometer System. The system must meet or exceed the following requirements: I. Minimum Performance Requirements/Salient Characteristics All of the following system requirements are minimum requirements. Equivalent requirements that differ from these minimum requirements shall be justified by the proposing vendor and evaluated by the FCC prior to purchase. General Requirements The system shall include a benchtop, ion trap mass spectrometer (MSn) interfaced with an ultra-high pressure liquid chromatography (U(H)PLC) system to form a complete LC-MSn system. The system shall include a PC-based data system/instrument controller including operating system, instrument control/data acquisition/data analysis software, monitor, and laser printer. The system shall include electrospray ionization (ESI), atmospheric pressure chemical ionization (APCI) ionization sources, and a direct probe for analysis of solid samples. Ion Trap Mass Spectrometer The ionization sources shall be capable of supporting ESI, APCI, and a direct probe for the analysis of solid samples and shall have an option for upgrading/adding atmospheric pressure photo-ionization (APPI). The ionization sources shall be able to be changed without breaking the vacuum of the mass spectrometer. The transfer ion optics shall be designed for high stability and ion transmission efficiency and must include an ion funnel, stacked ring ion guide, or similar mechanism to provide efficient ion delivery to the mass analyzer. The vacuum system must include a low maintenance split flow drag pump and software-integrated pressure gauges. The MSn system shall have a minimum mass range of m/z 15-2000. The MSn system shall have capability for high-resolution scan to resolve isotopic envelopes, of ions of at least 8+ charge state at a peak width of <0.1 Da from 15-2000 Da at a scan speed of at least 5200 Da/sec The MSn system shall have the ability to perform polarity switching experiments to detect positive and negative ions in a single LC-MS analysis. Polarity switching must be possible at a 20 Hz rate or faster. The MSn system shall be an ion trap and shall be capable of isolation and fragmentation experiments including the following: Perform up to 5 stages of MSn automatically (1 ≤ n ≤ 5) Perform manual MSn for n=1 through 11 Isolate monoisotopic precursor ions up to m/z 1000 (doubly charged) and up to m/z 2000 (singly charged). The MSn system shall have the ability to determine the ion injection time into the ion trap without carrying out a pre-scan event to increase the instrument scan speed/decrease the instrument cycle time. The MSn system shall have capability to temporarily exclude an ion while allowing acquisition of MS/MS or MSn spectra; increases the selectivity of co-eluting compounds, and enhances the signal of a selected compound. The MSn system shall have capability to perform experiments for automated 3-stage data-dependent experiments for charge state determination and structural elucidation of multiply charged ions. The MSn system shall have the ability to exclude background ions on a list and include a list of precursor ions for MSn data acquisition. The MSn system shall have a feature which eliminates the low mass cutoff which is inherent with all ion trap mass spectrometers to observe low masses in MSn scans. The MSn system shall have an integrated syringe to allow for automated infusion under data system control. The system shall be capable of MS and MS/MS mass accuracy of not worse than ± 0.15 Da within the calibrated mass range. The system shall be capable of controlling HPLC systems from multiple vendors within the included MS software. The system shall be capable of detecting 125 fg/µL (250 fg) Reserpine at S/N 500:1 in full scan MS/MS mode. Manuals for the operation and maintenance of the system must be included. U(H)PLC System The system shall include a binary pump with high pressure mixing, a solvent degasser, a thermostat controlled autosampler and trays capable of operating under ultra-high pressures, a thermostat controlled column compartment and appropriate cables and event boards for operation. The system must have the capability of being configured for both UHPLC and conventional HPLC separations. The binary pump shall have continuous and fully automatic solvent compressibility compensation. The binary pump must have a configurable delay volume in order to support the use of LC columns 10 to 300 mm in length with internal diameters ranging from 1.0 to 4.6 mm and particle sizes ranging from <2 to 10 µm. The binary pump must have typical pulsation of ≤ 1% amplitude (or < 5 bar, whichever is greater) when operated isocratically at 2 mL/min with conventional HPLC back pressures. The maximum pressure requirement for the binary pump shall be at least 1300 bar. The binary pump shall have a flow rate range of at least 0.001 to 5 mL/min and be adjustable in 1 µL/min increments. The binary pump shall have a flow accuracy of ± 1% (or 10 µL/min, whichever is greater) or better. The binary pump shall have a flow precision of ≤ 0.075% RSD or ≤ 0.005 min SD. The autosampler shall be capable of injection volumes from 0.1 to 25 µL in 0.1 µL increments, without changing the injection loop and a total injection range of 0.1 to 5000 µL The autosampler shall provide injection volume precision (RSD) of ≤ 1% for injection volumes of 1 µL or greater. The autosampler shall provide injection volume accuracy of ± 0.5% or better for injection volumes of 10 µL. The autosampler shall be thermostat controlled with a temperature range of at least 4ºC to 40ºC. The thermostat controlled column compartment shall have a temperature stability of at least ± 0.1ºC. The thermostat controlled column compartment shall have a temperature range of ambient +10ºC to 90ºC controllable in 1 degree increments. Data System The system shall include single instrument computer and software sufficient to control, acquire data, process data, and export data for all components of the LC-MSn system provided. The system shall include a PC, flat screen color monitor, and laser printer suitable for use with instrument software. The system shall include all CD-ROMs needed to restore operation of the system in the event that the computer fails. The software shall allow the user to upload raw data files and detect peaks via a library search. The software shall allow the user to determine confirmation criteria including ion ratios, library searches, isotopic distributions, and defined fragmentation patterns to assist in identification. The system must be capable of backing up the acquired data, methods, tune files, calibrations and all QA/QC information to a network device or server. The computer system shall have all components necessary to operate the instrument with the following specifications: II. Trade and Service Specifications The system must be a complete, newly manufactured unit, not used and refurbished or previously used for demonstration. The Government must be able to expect routine customer service and technical support to be available from the vendor during its lifecycle. A minimum of one-year warranty is required with the purchase and shall include at a minimum: coverage on all non-consumable items and parts supplied including the base instrument and any sampling accessories. FOB destination to include training. An on-site 3-day training class for up to four users will be provided within 60 days of delivery such that operators may independently operate the instrument and increase familiarity and proficiency. The training shall include manuals, hardcopy or electronic, to be used during training, and shall include instruction on any normal maintenance of the system.