Description
Updated to extend deadline for respones until 3:00pm (Eastern) on Friday, May 15, 2020. Background The Food and Drug Administration (FDA) Northeast Medical Products Laboratory (NMPL) is tasked with performing a variety of analyses. High Performance Liquid Chromatography (HPLC) coupled with UV detection alone is not suitable for analysis of certain pharmaceuticals and especially in impurity testing. Pulsed Amperometric Detectors (PAD) have been employed to detect impurities in Heparin, adulterants in dietary supplements and antibiotics. The lab does not currently possess a Pulsed Amperometric Detector and consequently has not been able to fulfill requests to analyze samples requiring use of this detector. By adding a PAD to its arsenal, NMPL will be able to expand its analytical capabilities. Currently, NMPL analyses Heparin for Oversulfated Chondroitin Sulfate. With a Pulsed Amperometric Detector, the sensitivity of the method can be enhanced, and the method can be extended to the detection of additional impurities. Purpose NMPL needs to be able to analyze samples such as antibiotics that require a Pulsed Amperometric Detector (PAD) for detection. A PAD detector will also aid in impurity testing of Heparin and detection of adulterants in dietary supplements. NMPL seeks to acquire a Pulsed Amperometric Detector that will be coupled to an HPLC in order to expand its analytical capabilities in monitoring the quality of pharmaceutical products to aid in protecting the public from unsafe drugs. Requirements Technical Specifications: At a minimum, the Coulometric Titrator shall meet or exceed following specifications: Shall have a Pulsed Amperometric Detector capable of operating in DC, pulse or scan mode Shall have a versatile working and reference electrodes for use with samples such as antibiotics and carbohydrates Shall be equipped with a gold electrode Shall have reference electrode compatible with pH extremes (example, pH 2 – 13) Shall be compatible with Shimadzu HPLC and UHPLC (LC-20AT and LC-20ADXR) 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 twelve (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. Any necessary Preventative maintenance (PM) or Repair Services shall be included during the one (1) year warranty period. 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 three (3) to- five (5) users per delivery onsite location will be provided at time of installation or shortly thereafter (within thirty (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) 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).