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B-1 Background The Food and Drug Administration (FDA) requires water purification system for regulatory work in its elemental analysis program. The equipment will be used for processing samples for th... B-1 Background The Food and Drug Administration (FDA) requires water purification system for regulatory work in its elemental analysis program. The equipment will be used for processing samples for the following types of analyses: food, feed, dietary supplements, cosmetics, consumer complaints, and FERN samples for toxic metals, nutritional metals, and other elements at the San Francisco Laboratory (SANFL). B-2 Statement of Work Scope: The Contractor shall provide all resources necessary to accomplish the tasks and deliverables described in this Statement of Work (SOW). The Contractor shall provide water purification system that meet or exceed the requirements listed below: Salient Characteristics/Technical Specification: Must deliver at a minimum ASTM Type I ultrapure water with the following specifications: Conductivity/Resistivity: < 0.0555 µS/ > 18.0 M?-cm at 25 °C Total Carbon Count (TOC): < 2 ppb Must remove trace level ions and be suitable for use in trace elemental analysis at sub-part per trillion (ppt) levels by Inductively Coupled Plasma Mass Spectrometry (ICP-MS) with the following specifications: Arsenic (As): < 0.005 ppb Cadmium (Cd): < 0.006 ppb Mercury (Hg): < 0.004 ppb Lead (Pb): < 0.003 ppb Counts on ICP-MS: < 100 Must have adjustable manual dispense flow rate ranging from 50 mL/min to 2000 mL/min Must have a TOC meter that monitors in a range at least wide as 1-999 ppb on a continual basis during production/delivery Must have a high precision resistivity meter Must measure temperature to within 0.1 °C resolution Must have a dual wavelength UV lamp to oxidize organic compounds and destroy bacteria The unit must be compact and have all necessary parts to install on a wall, on the benchtop, or under the bench. Must have a flexible dispensing option for both small and large volume dispensing Must have an autofill function that can be pre-programmed to deliver a precise volume on command Must have a footswitch for one-tap/start for hands-free delivery Must have optimizer 0.1 µm filter Must have pressure regulator w/gauge Must have a protective cover of silicone to prevent damage caused from harsh chemicals used during analysis. Small footprint no larger than 13 ¼ -in width by 14 ¼ -in depth by 20-in in height Must be able to dispense 250mL to 5L in 250mL increments, 5L to 60L in 1L increments. Shall have LEDs on the front panel to indicate the operational or error status of the instrument. The display shall include water quality, and system status. Must meet ISO 9001 v 2000 standards (https://www.iso.org/standard/21823.html) Trade and Service Specification Equipment shall be delivered with all necessary supplies and accessories required for installation and start-up including standards for verifying equipment performance FOB Point destination to include inside delivery and clean-up of area after installation Contractor shall provide on-site training for 6 users at minimum. Training 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 consumables to be used during training Equipment must be a newly manufactured unit, not used and refurbished or previously used for demonstration Equipment must be warrantied for parts and labor for at least 12 months from the date of installation. The vendor must also be capable of servicing the instrument through the covered warranty period and shall include at a minimum: coverage on all non-consumable items and parts including base instrument, factory-certified replacement parts, engineer labor and travel costs Records and Reports: The Contractor shall compensate with the completion of each service call, inclusive of warranty service The paperwork will be provided to the team after each service. The paperwork will include the following: Equipment Name Manufacturer Model Number and Serial Number The reason for the service call Detailed description of the work performed The test instruments or 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 For information purposes, the on-site hours expended, and parts/components replaced The Contractor shall provide monthly reports to the FDA PROJECT OFFICER and Contract Specialist no later then the 5th business 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). Deliverables Deliverable Quantity Delivery Date Water purification system kit conforming to Technical Requirements and Trade and Service Specs 1 Within 60 days of award ASTM Type I water purification system 1 Within 60 days of award Deionizing Filter Pack 1 Within 60 days of award Polishing Cartridge dedicated to removal of trace elemental analysis contaminants (ppt and sub-ppt level) 1 Within 60 days of award Optimizer 0.1?m Filter 1 Within 60 days of award Pressure Regulator w/Gauge 1 Within 60 days of award Wall Mounting Bracket 1 Within 60 days of award Foot Pedal with 1 Within 60 days of award Silicone Protective Cover for unit 1 Within 60 days of award Installation and Qualification 1 Within 30 days of delivery Familiarization Training 1 Within 30 days of delivery Service Reports Varies within 1 day after receiving of service The delivery or services must be during regular business hours (Monday-Friday) during the times of 8:00 AM – 4:00 PM, excluding holidays. Shipping Destination/Place of Performance: Inside delivery required. LAB Location POC SANFL Food and Drug Administration 1201 Harbor Bay Parkway Alameda, CA 94502 Sally Yee, sally.yee@fda.hhs.gov, 510-337-6834 Dr. Tiffany Stewart, tiffany.stewart@fda.hhs.gov, 510-337-6759 Period of Performance: The Period of Performance begins the date of contract award execution and continues for one year (or longer depending on how long the OEM offered warranty period is) from the date of formal government acceptance