SOURCES SOUGHT
66 -- Sources Sought- Solid Phase Extraction Robot
- Notice Date
- 12/13/2013
- Notice Type
- Sources Sought
- NAICS
- 334516
— Analytical Laboratory Instrument Manufacturing
- Contracting Office
- Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services, 3900 NCTR Road, HFT-320, Bldg 50 | Rm 421, Jefferson, Arkansas, 72079, United States
- ZIP Code
- 72079
- Solicitation Number
- FDA-SS-1128288
- Archive Date
- 1/11/2014
- Point of Contact
- Christopher R. McGucken, Phone: 3018277161
- E-Mail Address
-
christopher.mcgucken@fda.hhs.gov
(christopher.mcgucken@fda.hhs.gov)
- Small Business Set-Aside
- N/A
- Description
- TITLE: Solid Phase Extraction (SPE) Robot for Integration into a Liquid Chromatograph. OPDIV: FDA, Center for Drug Evaluation and Research This is a SOURCES SOUGHT NOTICE to determine the availability of potential small businesses (e.g., 8(a), service-disabled veteran owned small business, HUBZone small business, small disadvantaged business, veteran-owned small business, and women-owned small business) in accordance with FAR 7.104(d). The potential small business will need to demonstrate the capability to perform all facets of the work described below. The sole intent of this Sources Sought Notice is to obtain capabilities for set-aside and procurement planning purposes. This is not an invitation for bid, request for proposal, or other solicitation, and in no way obligates the Food and Drug Administration (FDA) to award a contract. BACKGROUND The FDA Division of Product Quality Research (DPQR) requires a solid phase extraction (SPE) robot. This instrument will be used for sample cleanup and extraction of drugs and their metabolites from bloods. These samples typically come from pharmacokinetic and bioavailability/bioequivalence studies. A robot is needed to process the large number of samples contained in some studies which can number in the thousands. These studies are part of DPQR’s mission critical research on drug product quality. The robot needs to be directly integrated with an Agilent UHPLC for efficient sample analysis. A robot will result in much greater productivity which includes freeing DPQR scientists to conduct other work. CONTRACTOR REQUIREMENTS Contractors must respond to all of the following points by describing your experience and capabilities in fulfilling the requirement listed below: DPQR researchers require a robot capable of processing liquid samples using solid phase extraction (SPE). Robot shall interface directly with our Agilent 1260/1290 (ultra) high performance liquid chromatographs (HPLC): Hardware Technical Specifications: · Capable of unattended processing of at least 96 samples from cryo-tubes (preferred size 12.5 x 90mm and 12.5 x 48mm) · Ability to cool cryo-tubes down to 4 °C. · Maximum volume of 1mL aliquot removed from sample for extraction. Aliquot needs to be transferred to a secondary vial/tube. · Capable of adding 25µL internal standard to secondary tube and mixing prior to application to SPE column · Capable of extracting samples using 1 and 3mL SPE columns. · Ability to pipet in the range of 25-2500uL in the same run. Pipetting accuracy and precision of ≤5% at 25µL and ≤2% at 2500µL. · Adds liquid to the SPE column and forces liquid through using positive pressure. · User controlled flow rate through the SPE tube/plate with a lowest settable flow of 1.0mL/min or less · Can perform a typical 5 step procedure on an SPE tube (condition, condition, sample application, wash and elute, 2.5mL each step at 1mL/min) on 96 samples in 24 hours or less · Capable of adding solutions/solvents from at least 4 different reservoirs (e.g. 2 conditioning solvents, wash solvent, elution solvent) with a reservoir volume of at least 250mL · Can collect SPE column eluants into at least 96 collection tubes or vials · Capable of collecting up to 3mL of liquid into one vial/tube in the elution step from the SPE column · Vacuum dryer for drying multiple SPE column eluents simultaneously. · Can add liquid to dried tube and mix to reconstitute. · Shall inject reconstituted samples from the robot directly onto an Agilent 1260/1290 HPLC without user transferring samples. · Computer control which allows use of at least 10 different extraction procedures within the same run with software included · Shall work with electrical receptacle NEMA 5-20R · Requires no bench top space in addition to UHPLC/MS. (e.g. Can sit on top of an Agilent 6410 MS) · Robot has a shield or other barrier on the front of the unit between the user and the samples. Optional accessories : · High speed mixer or vortexer (2000RPM or greater) · 2 additional reservoirs for a second wash solvent and reconstitution solvent for a total of 6 reservoirs Delivery, Installation and Training: • Full hardware, software and peripheral installation • Five (5) days on-site hardware and software training. • Parts and labor warranty of at least one year Capability statements must demonstrate the minimum requirements outlined above. Please address each in the order listed above. Please provide the follow Business information: DUNS Number Company Name Company Address. Company Point of Contact, phone number and email address Type of company under NAICS, as validated via the System for Award Management (SAM). Additional information on NAICS codes can be found at www.sba.gov. Any potential government contract must be registered on the SAM located at http://www.sam.gov/index.asp. Corporate structure (corporation, LLC, sole proprietorship, partnership, limited liability partnership, professional corporation, etc.); Current GSA Schedules appropriate to this Sources Sought Current Government Wide Agency Contracts (GWACs) Point of Contact, phone number and email address of individuals who can verify the demonstrated capabilities identified in the responses. Interested parties having the capabilities necessary to perform the stated requirements may submit capability statements via email or regular mail to the point of contact listed below. Responses shall be limited to 10 pages. Responses must be received not later than 3:00 PM Noon EST, December 27th, 2013. Capability statements will not be returned and will not be accepted after the due date. Documentation should be emailed to: Christopher.McGucken@fda.hhs.gov
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/NCTR/FDA-SS-1128288/listing.html)
- Place of Performance
- Address: US Food and Drug Administration, White Oak Campus, 10903 New Hampshire Avenue, WO Building 62 Loading Dock, Silver Spring, MD 20993, Silver Spring, Maryland, 20993, United States
- Zip Code: 20993
- Zip Code: 20993
- Record
- SN03251570-W 20131215/131213234437-6c7ded73807a225189c3fa1065165dbb (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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