Tenders of Food And Drug Administration Usa
Tenders of Food And Drug Administration Usa
FOOD AND DRUG ADMINISTRATION USA Tender
Laboratory Equipment and Services
United States
Perpetual Schrodinger Suite License Brand Name Or Equal With Maintenance
Closing Date23 Feb 2024
Tender AmountRefer Documents
FOOD AND DRUG ADMINISTRATION USA Tender
Software and IT Solutions...+1Healthcare and Medicine
United States
Software Bill Of Materials (sbom) Validation Comparison Set
Closing Date20 Sep 2024
Tender AmountUSD 986.7 K
This is an estimated amount, exact amount may vary.
FOOD AND DRUG ADMINISTRATION USA Tender
United States
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************************
Closing Date29 Aug 2024
Tender AmountRefer Documents
FOOD AND DRUG ADMINISTRATION USA Tender
Corrigendum : Closing Date Modified
United States
508 Compliance Remediation Services
Closing Date3 Sep 2024
Tender AmountRefer Documents
FOOD AND DRUG ADMINISTRATION USA Tender
United States
Intent To Sole Source (steritest Pump)
Closing Date4 Sep 2024
Tender AmountRefer Documents
FOOD AND DRUG ADMINISTRATION USA Tender
United States
Intent To Sole Source Purchase Of Controller Computer And Software For Sciex Liquid Chromatograph-triple Quadrupole Mass Spectrometers
Closing Date4 Sep 2024
Tender AmountRefer Documents
FOOD AND DRUG ADMINISTRATION USA Tender
FOOD AND DRUG ADMINISTRATION USA Tender
United States
Office Of Ethics And Integrity (oei) Analytics And Decision Support
Closing Date26 Aug 2024
Tender AmountRefer Documents
FOOD AND DRUG ADMINISTRATION USA Tender
United States
Low Volume Isothermal Titration Calorimeter
Closing Date12 Sep 2024
Tender AmountRefer Documents
FOOD AND DRUG ADMINISTRATION USA Tender
United States
Subscription To News, Schedules, Federal Budget And Appropriations
Closing Date19 Sep 2024
Tender AmountRefer Documents
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