FOOD AND DRUG ADMINISTRATION USA Tender

Purpose this Sources Sought Notice (ssn) Is For Market Research, Information, And Planning Purposesonly. This Ssn Does Not In Any Way Constitute A Request For Quotation (rfq) And As Such, Shall Not Be Construed As A Commitment By The Government (implied Or Otherwise) To Issue A Solicitation Or Ultimately Award A Contract. this Announcement Is Specifically Targeted To A) Identify Vendors Capable Of Providing The Equipment And Service As Detailed In This Notice, And B) Vendors Capable Of Providing A Domestic Product Offering. Responses From Small And Other Than Small Businesses Are Appreciated And Accepted. requirement the Office Of Regulatory Science (ors), Division Of Bioanalytical Chemistry (dbc), Chemical Contaminants Branch (chcb) Requires The Purchase Of A Microwave Digestion System To Effectively Decompose/digest Samples Of Foods, Cosmetics, And Dietary Supplements For Accurate Determination Of Toxic And Nutrient Elements. the Chemical Contaminants Branch Within The Office Of Regulatory Science, Division Of Bioanalytical Chemistry Requires The Purchase Of A Benchtop Microwave Digestion System For The Analysis Of Contaminants And Adulterants In Cosmetics, Dietary Supplements, And Foods. The Requested Benchtop Microwave Digestion System Will Provide The Necessary Requirements That Are Critical For The Development, Testing, And Validation Of New Methods For Fda Laboratories (cfsan And Ora) Dedicated To Food Safety, Including Fda’s Closer To Zero Approach To Lower Toxic Elements In Baby Foods. ors, Dbc, And Chcb Requires That The Proposed Equipment Meet Or Out-perform The Specifications As Described Below. The Proposed Equipment Is Required To Continue And Expand The Efforts Of The Us Fda To Protect The Us Food Supply And Respond To Emergencies In A Timely Manner. minimum Salient Characteristics: system Requirements The Major Components Of The System Shall Include: benchtop Microwave Digestion System With The Following Characteristics: benchtop System single Reaction Cell System equipped For Operating Temperatures Up To 300⁰c And Operating Pressure Up To 199 Bar. the System Will Have The Capabilities Of Performing Hcl/aqua Regia Digestions. capable Of Digesting 40 Samples At Once include A Recirculating Chiller include Tfm Vials And Caps the System Shall Be: warranted For Parts And Labor For At Least 1 Year From Date Of Installation the System Must Be Newly Manufactured Unit, Not Used Or Refurbished, Or Previously Used For Demonstration. the System Must Meet All The Technical Specifications Specified Below the Vendor Shall: vendor Is Responsible For Delivery And Installation Of The Instrument. The Fda Project Officer Will Perform Inspection And Acceptance Of The Microwave the Vendor Will Demonstrate Upon Installation That The Item Will Be All Performance Specifications By The Manufacturer provide An Instrument Familiarization For Fda Users Will Be Provided By The Installation Specialist technical Requirements: the Instrument Purchased Shall Meet The Following Technical Requirements: 1l Stainless Steel Single Reaction Chamber (src) Reaction Chamber With Ptfe/tfm Liner ability To Run Any Acid Chemistry, Including Aqua Regia And & Large Volumes Of Hcl, Using Vials With Loose-fitting Caps noiseless Water-cooled Magnetron Providing Superior Heating Efficiency contactless Temperature Control Providing High Precision And Responsiveness automated Pre-pressurization Of Src Chamber And Flushing Of Nitrogen Lines Postdigestion software-controlled Pneumatic Lift Of Ptfe/tfm Liner dedicated Lift Motor To Lower And Raise Cover And Rack Fully Controlled By The Software automatic Opening/closing Of The Src Chamber With Auto Lift safety Interlocks On Front Door Viewing Window, Chamber & Clamp Position, Chamber Temperature & Pressure separated Inlet And Outlet High-pressure Lines To Minimize Risk Of Contamination quartz Bottom To Avoid Acid Diffusion power Up To 1,500w. Microprocessor Controlled. Power 220v, 60hz microwave Frequency 2.45 Ghz, Max Temp. 300°c. Max. Pressure 199 Bar twin Exhaust Ducts For Removal Of Acid Vapors magnetic Stirring h150-1000 Labtech Recirculating Chiller With Pid Temperature Control, Digital Readout, Pressure Gauge And Liquid Level Indicator, 220v, 50/60hz capable Of Digesting 40 Samples In A Single Batch accessories: 40 Positions Rack With Glass Vials And Caps 20 Positions Rack With Tfm Vials And Caps (x4) 27 Positions Rack With Tfm Vials And Caps (x1) tfm Vessel 97,5x156 (x1) sample Rack 40 Positions ø 10mm (x3) ptfe Cap For Vial ø 16 Mm (x100) tfm Vial 16/115 (ø 16 Mm/13 Mm X 115 Mm) Ca. 15 Ml (x100) ptfe Cap For Glass & Tfm Inserts - 12-13mm. For Use In 19/22-position Uw Rack And Sk-15micro-inserts (x40). ptfe Vial 12/100 (12mm O/d X 100mm) Ca 7 Ml Capacity. For Use In 22 Position Rack. (x40) one Year Original Factory Warranty. Valid For 12 Months From The Date Of Installation But No Longer Than 13 Months From Ship Date (included In Price) buck-boost Transformer To Step Up 208vac To 230vac. Supplied With Nema 6-15 Plug. (x1) recirculating Chiller With Temperature Control, Digital Readout, Pressure Gauge And Liquid Level Indicator, 220v, 50/60hz 1 Day Installation And Operator Training Including Instrument Operation And Routine Maintenance (includes Travel And Expenses) (x1) shipping Destination/place Of Performance ship To And Perform At: u.s. Food And Drug Administration fda/cfsan attention: Tbd 5001 Campus Drive college Park, Md 20740 capable Firms Must Submit Their Responses To The Below Questions. requested Information please Provide The Following Information: company's Name, Mailing Address, Cage Code, And Unique Entity Identifier (uei) recommended North American Industry Classification System (naics) Code That Your Company Utilizes For In Support Of The Following Equipment: Ultrawave 3 Ecr Automatic Simultaneous Digestion System Benchtop Instrument With Single Reaction Chamber (src) Technology. what Is Your Company Size? If Small, What Is Your Socio-economic Status? identify Any Gsa Schedule Contract Or Other Current Government-wide Contract (e.g., Gwac Or Bpa) That Your Company Currently Holds And Offers These Products/services Under. domestic Manufacturing Status. technical Specifications For The Proposed Solution. disclaimer the Government Will Not Reimburse Respondents For Any Costs Associated With Information Submitted In Response To The Ssn. Responders Are Solely Responsible For All Expenses Associated With Responding To This Ssn. responses To This Ssn Are Not Offers And Cannot Be Accepted By The Government For The Basis Of Forming A Binding Contract. This Ssn Is Being Issued Solely For The Purpose Of Gathering Information For Planning Purposes. This Ssn Does Not Commit The Government To A Contract For Any Supply Or Service. Furthermore, The Government Is Not At This Time Seeking Quotes And Will Not Accept Unsolicited Quotes. respondents To This Ssn May Be Requested To Provide Additional Information/details Based On Their Initial Submittals. The Government Reserves The Right To Select, One (1), Some, Or None Of The Submissions For Further Information. Vendors Who Submit Information In Response To This Ssn Do So With The Understanding That U.s. Government Personnel May Review Their Materials And Or Data. response Deadline responses Shall Be Submitted In Writing By E-mail To Contract Specialist, Iris Johnson, At Iris.johnson1@fda.hhs.gov, No Later Than August 8, 2024, 12:00 Pm Et. Questions Regarding This Ssn Must Be Submitted Via Email As Telephone Inquiries Willnotbe Addressed And Shallnotcontain Proprietary Or Classified Information.