Description
Background The Office of Pharmaceutical Quality Research (OPQR), part of CDER’s super Office of Pharmaceutical Quality, protects the public health by assuring the quality and availability of drugs and biologics by conducting mission-relevant research that addresses current and future needs to support: Science- and risk-based quality assessments of regulatory submissions; Standard, guidance, and policy development; Pharmaceutical quality surveillance, and Rapid responses to public health issues. The acquisition 1290 Infinity II LC System with ELSD will provide a robust high-performance liquid chromatography instrument suitable for a wide range of analytical applications. Scope To obtain an Agilent 1290 Infinity II LC System with DAD and ELSD or equivalent for use in DPQR- STL. Requirement The contractor shall provide (1) Agilent 1290 II LC System with DAD and ELSD or equivalent with the following salient characteristics: The Ultra-High Performance Liquid Chromatograph shall comply with the following quality requirements: ISO/IEC 17025-2017 https://www.iso.org/standard/39883.html, https://www.iso.org/standard/66912.html ISO 9001:2008 https://www.iso.org/standard/46486.html 21 CFR Part 11 Compliance https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm USP, cGMP/cGLP https://login.usp.org/cas/login?service=http%3A%2F%2Fonline.uspnf.com%2Fcas%2Flogin High Speed Pump Settable flow range: Setpoints 0.001—5 ml/min, in 0.001 ml/min increments Flow precision: ≤0.07 % RSD or 0.005 min SD, whatever is greater (0.2—5.0 ml/min) Active Seal Wash: Included with sensor Flow accuracy: 1 <±1.0 % Multisampler Maximum load of 16 microplates and up to 6,144 samples for unmatched sample capacity Integrated sample thermostat Multi-wash capability. Dual needle injection Column Compartment Compartment capacity up to 8 columns Column Compartment Temperature Range 4 °C to 110 °C Heat Exchanger Column Tracing Diode Array Detector RFID technology for flow cells Simultaneous detection of up to eight signals for increased sensitivity and selectivity Less baseline drift for more reliable and robust peak integration Pressure Range up to 1300 bar (18,855 psi) Full Audit Trail Capabilities Inside Delivery Installation, instrument configuration, and operational qualification Familiarization Training for 3-5 users Trade and Service Specs Equipment shall be newly manufactured, not used, refurbished, or previously used for demonstration. The Contractor shall provide a minimum of a one-year manufacturing warranty for all manufactured equipment and parts. The warranty shall be included with the equipment and not separately priced. The warranty 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 troubleshooting, which is staffed by senior engineers to provide a high level of expertise for troubleshooting the instrument. The Contractor shall provide training and validation of the equipment and software on site at the time of installation. Sufficient familiarization training for 3-5 users per delivery onsite location will be provided, 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. The qualification and verification report shall include the standard operating procedures and the allowed manufacturer limits for the instrument. A copy of the calibration report and the qualification and verification report(s) shall be reviewed and approved by an FDA representative before installation of the equipment and execution of protocols. Inside delivery, disposing pallets, boxes, and any associated garbage, and unpacking the equipment and inventory of parts with a lab representative.