Inactive
Notice ID:FDA-RFQ-24Q1277777
BACKGROUND The regulatory laboratories of the Food and Drug Administration (FDA), conduct a range of chemical analyses on pharmaceutical products to determine if they meet regulatory requirements. A K...
BACKGROUND The regulatory laboratories of the Food and Drug Administration (FDA), conduct a range of chemical analyses on pharmaceutical products to determine if they meet regulatory requirements. A Karl Fischer oven autosampler and accessories for an existing Karl Fischer titration instrument is necessary to complete United States Pharmacopeia analyses on pharmaceutical regulatory samples. OBJECTIVE Purchase of one (1) Karl Fischer oven autosampler and accessories to be interfaced to a Karl Fischer titrator for the Irvine Medical Products Laboratory (IRVLMP), Irvine, CA. REQUIREMENTS The contractor shall provide the minimum requirements under this contract: Oven Autosampler Unit Shall be compatible with a Mettler Toledo Karl Fischer titrator with the model/serial number noted below: Mettler Toledo Model/Serial: V30S Volumetric KF Titrator / SNR: C034911273 Shall uses the oven extraction technique for water determination by heating to sample specific temperature and transferring the water evaporates into a titration vessel by a stream of dry air or nitrogen. Equipped with oven autosampler controlled by existing Lab-X software (version 12.0.0 Build 728) or includes software for controls that is compatible with Lab-X (version 12.0.0 Build 728) and includes software license that can be interfaced with an existing Mettler Toledo V30S Karl Fischer titrator as described above and necessary connections available for integrated control via Lab-X. All necessary parts and accessories shall interface with the existing autosampler the Mettler Toledo Karl Fischer Titrator identified above. The oven autosampler must have a sample management capacity of at least 24 vials and vial volume of 10 mL each or better. Equipped for temperature scan and ramp functionality. Range of 40°C – 280°C or better with the following requirements +/- 3°C accuracy or better +/-0.5°C stability or better +/- 0.5°C reproducibility or better Heating rate of 70°C/min or better Includes an air pump with electronic gas flowmeter integrated to the autosampler for generating gas flow needed to precisely transfer water extracted from the sample to the titration cell Provides flexible method with multiple loops Has a tube set for automatic solvent exchange and solvent manager Has a heated transfer tube Unit weight is less than or equal to 10 kilograms Dimensions are no more than (HxWxD) 50 cm x 30 cm x 50 cm Standard North American electrical outlet capability of 120v, 60hz NEMA 5-15 or 5-20 plugs. Additional Accessories includes Set of no less than 150 sample vials and caps compatible with oven autosampler for Karl Fischer analysis Installation and calibration of the oven autosampler and configured to the current Karl Fischer V30S titrator in lab described above including standard testing, verification, and qualification of the autosampler and software controls. On-site operation training on the use of the oven autosampler unit for running Karl Fischer analysis including software controls for up to 4 individuals within 30 days of installation. Trade and Service Specifications- The Contractor shall ensure the following: 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 troubleshooting, which is staffed by senior engineers to provide a high level of expertise for troubleshooting the instrument. Sufficient familiarization training for four (4) users at the 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, integration and testing with a trained and certified field service engineer. Calibration solutions and consumables used for the installation are to be included. *************************See Attached Solicitation for Full Details************************
