PDA Detector

Please see the attached solicitation for full deails. Background One of the recently installed AB Sciex 4500 LC-MS/MS instruments at the FDA Denver (DENL) Laboratory has been designated for use by the Color Additive Analysis Program, for further development of methods for the detection of dyes in foods and regulated products. Dye profiles are primarily characterized by their characteristic absorbance profiles (UV-Vis spectra), as well as by their mass spectrometric properties. However, many dyes are structural isomers of each other and may have identical mass values and fragmentation patterns. Thus, definitive characterization of dye molecules requires the combination of mass and UV-Visible spectral data (as well as chromatographic retention times). A photodiode array detector (PDA) is required to be able to collect full spectral scans for every compound in the chromatogram. However, the purchase of this instrument did not include a PDA detector, so it must be added on to the system and then qualified for use with regulatory samples. Purpose The objective for this request is to add a compatible PDA detector to the existing AB Sciex 4500 LC-MS/MS system designated for color additive use at the FDA Denver Laboratory. Requirements This requirement is being solicited in accordance with FAR 52.211-6, Brand Name or Equal . The Contractor shall deliver, install, and qualify a PDA detector (and all required accessories) to be added to an existing AB Sciex 4500 LC-MS/MS (Exion LC AC Stack) system, ensuring that the new detector can be controlled by the existing LC control software, and provide compatible data that is viewable in the Sciex Analyst software. The Contractor shall provide one new PDA detector that is compatible and can be integrated as a detector in an AB Sciex 4500 LC-MS/MS system having an Exion LC AC stack and Q Trap Mass Spectrometer. Contractor shall provide delivery of the module to the Denver FDA Laboratory, and provide on-site installation (including any required accessories) by a qualified service technician. Contractor shall demonstrate upon installation that all items meet performance specifications and provide documentation of required qualifications (IQ/OQ/PQ) at completion of installation. Instrument module shall not be accepted until the specifications have been met and the qualifications performed. Contractor shall provide on-site instrument module familiarization to the analysts who will be operating the instrument. Contractor shall provide a warranty for the PDA module for parts and labor for 12 months from the date of installation acceptance. Technical Specifications: Instrument module shall be a Photodiode Array (PDA) or Diode Array Detector (DAD) intended as a flow-through detector for an LC system. PDA (or DAD) module must be compatible for use with an AB Sciex Exion LC AC stack LC-MS/MS with 4500 QTrap mass spectrometer. PDA flow cell must be able to tolerate pressures up to 1,000 psi and be resistant to common organic solvents such as methanol and acetonitrile, with a wide pH (2-12) tolerance. PDA module should have an analytical flow cell with at least a 10 mm path length (25 mm preferred) having 0.1 mm ID tubing on the cell inlet and outlet. PDA module should utilize and include a deuterium lamp, with a wavelength range of at least 190 to 700 nm, having at least 1,024 PDA elements, and a spectral resolution of 1.4 nm or better. Background noise level should be no more than 0.2 x 10^-5 AU, and drift no more than 1 x 10-3 AU/hr/°C. Response should include any additional accessories needed to ensure operation of PDA module within specs described in #4 above (even at flow rates ≥ 0.5 mL/min), including in-line mixers, data and power cables, or other required items. PDA module should be completely controllable using the Sciex Analyst software and produce UV-Visible spectral data that is entirely compatible with and can be processed using the Sciex Analyst software, in conjunction with chromatographic and mass spectral data collected by the instrument. PDA module should be operable between 4-35°C and relative humidity of 20-85% and utilize a standard 110 V-AC (60 Hz) power outlet. On-site installation (of module and any associated accessories), integration into existing Sciex 4500 LC-MS/MS system, qualification for regulatory use (IQ/OQ/PQ), and user familiarization is required for PDA module. Trade and Service Specifications: The module(s) and required accessories must be newly manufactured units, not previously used, refurbished, or 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. The module(s) must be warranted for parts and labor for 12 months from the date of acceptance. The vendor must also be capable of servicing the module through an extended warranty or service contract. This requirement does not obligate the Government to purchase an extended warranty. FOB point destination to include inside delivery, set-up, installation, clean-up of area, and familiarization training. Sufficient training for up to four users will be provided during installation, such that operators may independently operate the instrument and increase familiarity and proficiency. The training shall include manuals and consumables to be used during training. The contractor provides for installation qualification (IQ/OQ/PQ) and provide associated documentation at completion of installation.