Description
Please see the attached solicitation for full description. Background The US Food and Drug Administration (FDA)’s Pacific Southwest Medical Products Laboratory (PSMPL) has an Existing Thermo Scientific LTQ VELOS PRO Mass Spectrometry (MS) System with a Thermo Scientific VANQUISH FLEX BINARY High-Performance Liquid Chromatography (HPLC) System with TRACEFINDER 4.1 EFS Software and License. However, the instrument did not include the Thermo Scientific DAD Detector & Flow Cell. Therefore, there is need to purchase a new Thermo Scientific DAD Detector & Flow Cell for this Existing Thermo Scientific LC/MS System. Purpose The US Food and Drug Administration (FDA)’s Pacific Southwest Medical Products Laboratory (PSMPL) located in Irvine, CA, is an ISO 17025 accredited laboratories involved in the analysis of FDA regulated products and other scientific activities in support of the agency’s public health mission. The U.S. FDA’s continued efforts to protect the public often depends on the agency’s laboratories being able to quickly and accurately analyze samples and report those results for regulatory action. The Pacific Southwest Medical Products Laboratory (PSMPL) gets several regulatory pharmaceutical samples for analysis and in recent years the number of samples have increased. PSMPL has an Existing Thermo Scientific LTQ VELOS PRO Mass Spectrometry (MS) System with a Thermo Scientific VANQUISH FLEX BINARY High-Performance Liquid Chromatography (HPLC) System with TRACEFINDER 4.1 EFS Software and License. However, this instrument did not include the DAD Detector & Flow Cell. Without these instrument parts, the existing Thermo Scientific LC/MS System can’t be effectively used to perform regulatory analyses. This instrument will primarily be used for health fraud program at PSMPL - for identification and quantitation of erectile dysfunction and weight loss drugs in dietary supplements. Requirements The Contractor shall supply and deliver One (1) new DAD Detector & Flow Cell to FDA’s ORA/ORS/PSMPL Drug Chemistry Section, Irvine, CA. The DAD Detector and Flow Cell shall be wholly compatible with PSMPL’s existing Thermo Scientific LTQ VELOS PRO Mass Spectrometry (MS) System with a Thermo Scientific VANQUISH FLEX BINARY High-Performance Liquid Chromatography (HPLC) System with TRACEFINDER 4.1 EFS Software and License. The serial # of the Thermo Scientific LTQ VELOS PRO MS System is LTQ40679 and the Serial # of the VANQUISH FLEX BINARY HPLC System is 8313930. Both were purchased in 2019 and are in good working condition. Additionally, the Contractor shall be responsible for delivery, installation, qualification of the equipment, as well as providing familiarization training to FDA staff. See below for details. The instrument shall meet the salient characteristics, trade and service specifications described below. Technical Specifications: At a minimum, the new DAD Detector & Flow Cell shall be wholly compatible with PSMPL’s Existing Thermo Scientific LTQ VELOS PRO Mass Spectrometry (MS) System with a Thermo Scientific VANQUISH FLEX BINARY High-Performance Liquid Chromatography (HPLC) System shall meet or exceed following specifications: Optical Design - Single-beam, reverse-optics design with concave holographic grating, achromatic optics, 1024 element photodiode array Maximum Data Collection Rate 250 Hz (including 3D acquisition) Wavelength Range 190–800 nm Noise <±6 μAU at 254 nm (standard flow cell, bandwidth: 4 nm, slit width: wide, time constant: 2 s) Drift <1 mAU/hour at 254 nm Linearity <5% at 2.2 AU (typically <5% at 2.7 AU) Slit Width Settable: Wide, narrow Spectral Bandwidth Pixel resolution: 0.6 nm (average) Light Source Deuterium lamp, tungsten lamp Number of Signal Channels 10 + 3D field Wavelength Accuracy ±1 nm Wavelength Repeatability ±0.1 nm Wavelength Calibration - Internal calibration with D-alpha line of the deuterium lamp Wavelength Validation - Internal validation with holmium oxide filter Flow Cell - 7 mm light path length, 2.5 μL flow cell volume, and is made of titanium. Flow Cell Pressure Limit - The cell can operate at post-column pressures of up to 120 bar (1740 psi, 12 MPa). Trade and Service Specifications: The instrument must be a newly manufactured unit, not used and refurbished or previously used for demonstration. FOB Point destination to include inside delivery and clean-up of area after installation. The entire system must be warranted for parts and labor for 12 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 least a one (1) year warranty and shall 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. Instrument operators shall have access 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. Preventative maintenance (PM) visit shall be included for the base contract year. This visit shall be inclusive of all parts, labors, travel, consumables, and supplies which are necessary to complete the OEM’s suggested PM protocol. Service engineers which perform this service shall trained by the OEM. Sufficient familiarization training for 3-5 users per delivery onsite location will be provided at time of installation or shortly thereafter (within 30 days), such that operators may independently operate the instrument and with increased familiarity and proficiency. The training shall include manuals and any consumables to be used during training. The Contractor shall provide installation qualification with an employee who can provide proof of installation qualification/Operation qualification (IQ/OQ) certification. 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).