Solid Phase Extraction (SPE) Robot.

 This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Subpart 12.6, (STREAMLINED PROCEDURES FOR EVALUATION AND SOLICITATION FOR COMMERCIAL ITEMS) as supplemented with additional information included in this notice. This announcement constitutes the only solicitation.

This solicitation is issued as a Request for Quotations (RFQ), using the Simplified Acquisitions Procedures of FAR 13. The solicitation document/incorporated provisions and clauses are those in effect through the current Federal Acquisition Circular: FAC 2005-64.

The Government intends to award a Firm Fixed-Price contract.

1.) DESCRIPTION.

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. 

2) PRICING CHART: All charges must be included in the quote. Any charges presented after contract award shall be unacceptable. 

3.) Salient Characteristics of the Solid Phase Extraction Robot

DPQR researchers require a robot capable of processing liquid samples using solid phase extraction (SPE).  Robot shall interface directly with an existing Agilent 1260/1290 (ultra) high performance liquid chromatographs (HPLC):

• Shall be capable of unattended processing of at least 96 samples from cryo-tubes (preferred size 12.5 x 90mm and 12.5 x 48mm)
• Shall have the 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.
• Shall be capable of adding 25µL internal standard to secondary tube and mixing prior to application to SPE column
• Shall be capable of extracting samples using 1 and 3mL SPE columns.
• Shall have the 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.
• Shall add liquid to the SPE column and forces liquid through using positive pressure.
• Shall have user controlled flow rate through the SPE tube/plate with a lowest settable flow of 1.0mL/min or less
• Shall have the capability to 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
• Shall have the capability 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
• Shall have the ability to collect SPE column eluants into at least 96 collection tubes or vials
• Shall be capable of collecting up to 3mL of liquid into one vial/tube in the elution step from the SPE column
• Shall have vacuum dryer for drying multiple SPE column eluents simultaneously.
• Shall have the ability to 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. 
• Shall have 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
• Shall require no bench top space in addition to UHPLC/MS.  (e.g. Can sit on top of  an Agilent 6410 MS)
• Robot shall have a shield or other barrier on the front of the unit between the user and the samples.

Shall have the following optional accessories or functionalities:

• 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

4) Packing, Marking, Delivery and Shipping:

-All deliverables required under this contract shall be packaged, marked and shipped in accordance with Government specifications. 

-At a minimum, all deliverables shall be marked with the contract number and contractor’s name.

-The Contractor shall guarantee that all required materials shall be delivered in immediate usable and acceptable condition, packages of the robot should be sealed and of robust construction.

The Delivery of the Robot shall be made to:

The US Food and Drug Administration

White Oak Campus

10903 New Hampshire Avenue

WO Building 62 Loading Dock

Silver Spring, MD 20993

The assembly location shall be:

The US Food and Drug Administration

White Oak Campus

10903 New Hampshire Avenue

WO Building 64, Room 1017

Silver Spring, MD 20993

The robot will be delivered within 180 days of contract award. Installation includes necessary setup and connections to operate the system 

5) RFQ Instructions:

The vendor must complete the Pricing Chart provided in this RFQ. Responses shall have the following information:

- Identified with the RFQ number.

- The vendor must complete the Pricing Chart above.

- Responses shall be submitted to the Contract Specialist’s email below.

- Quotes must be for all the items requested or none.

- Quotes must remain valid through September 30th, 2014.

      - Response Due Date shall be no later than: January, 31st at 12:00 pm EST.

EVALUATION AWARD CRITERIA

The Government shall award this contract to the Lowest Price Technically Acceptable (LPTA) Quote.

GENERAL INFORMATION   

CONTRACTING POINT OF CONTACT: 

Christopher R. McGucken

 5630 Fishers Lane, Room

 Rockville MD 20857

 Voice: 301.827.7161   

 Email:  Christ[email protected]