SOLICITATION NOTICE
66 -- Subvisible Particle Analysis System and Accessories
- Notice Date
- 1/24/2014
- Notice Type
- Combined Synopsis/Solicitation
- 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-SOL-1128209
- Archive Date
- 2/22/2014
- 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
- Combined Synopsis/Solicitation: FDA-SOL-1128209 Subvisible Particle Analysis System and Accessories 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 Division of Product Quality Research (DPQR) is seeking an imaging-based particle counter with accessories designed to characterize and quantify aggregates and particulates in biotherapeutics. The system, accessories, and consumables are necessary to be able to optimize and monitor formulations using unique characterization metrics. The evaluation of in-vitro critical quality attributes is of great importance for advancing the pharmaceutical drug product development to better protect the public’s health. 2) PRICING CHART: All charges must be included in the quote. Any charges presented after contract award shall be unacceptable. Item # Description Qty. Unit Price Total 1 Automated Flow Microscope System with Autosampler. To include system software, licenses and start-up consumables. 1 2 Comprehensive One Year Service Plan. Including on-site repairs and all parts and labor. 1 3 Autosampler, Fitting, Sample Inlet Port 4 4 Cable and Motor Assembly, Precision stirrer 1 5 Consumable Kits; to include tubing, fittings, swabs, and tips. 3 6 Flow Cell, 100μm, 1.6mm 15 7 Controller, precision stirrer 1 8 Precision stirrer operation manual 1 9 Pipette tips liquid sensing 6 10 Reservoir, 290mL single well 5 11 NIST certified standards, particle size 10 μm, 15 mL 3 12 NIST certified standards, particle size 15 μm, 15 mL 3 13 NIST certified standards, particle size 1 μm, 15 mL 3 14 NIST certified standards, particle size 25 μm, 15 mL 3 15 NIST certified standards, particle size 2 μm, 15 mL 3 16 NIST certified standards, particle size 5 μm, 15 mL 3 17 Particle concentration standard, 10 μm, 25mL 4 18 Particle concentration standard, 15 μm, 25mL 3 19 Particle concentration standard, 25 μm, 25mL 3 20 Particle concentration standard, 2 μm, 25mL 4 21 Particle concentration standard, 5 μm, 25mL 4 22 Precision stirrer kit, 10 mL syringe barrel 2 23 Precision stirrer kit, 20 mL syringe barrel 2 24 Precision stirrer kit, 2 mL syringe barrel 2 25 Syringe Guide, 1 Ml, 10 mL barrel 1 26 Syringe Guide, 2 mL, 10 mL barrel 1 27 Syringe Barrel, Silanized, 10 mL 4 28 Syringe Barrel, Silanized, 20 mL 4 29 Syringe Barrel, Silanized 2 mL 4 30 Spill Trays, precision stirrer 2 31 Stir rod coupler tubing 4 32 Stir rods, 2 mL barrel 4 33 Stir rods 4 34 Stirrer adaptor, 10 mL barrel 4 35 Stirrer adapter holder 4 36 Stirrer adapter, 20 mL barrel 4 37 Stirrer adapter, 2mL barrel 4 38 Stopcocks, slip fit, 2 way 1 39 Well plate, 96 x 1 mL 5 40 Well Plate, 96 x 2mL 7 41 Delivery 1 42 Installation 1 43 On-site Training 1 45 Option Year 1: Preventative Maintenance Service Plan 1 46 Option Year 2: Preventative Maintenance Service Plan 1 47 Option Year 3: Preventative Maintenance Service Plan 1 48 Option Year 4: Preventative Maintenance Service Plan 1 Grand Total 3.) Salient Characteristics of the Solid Phase Extraction Robot Requested is an imaging-based particle counter with accessories and consumables designed to characterize and quantify aggregates and particulates in biotherapeutics. The required features of this system are: Item 1: Imaging-based particle counter with Autosampler. The particle counter shall encompass the following specifications: · Shall image, count, and size particles in liquid formulations. · Shall distinguish silicone oil droplets from aggregates. · Shall characterize and quantify particles after reconstituting lyophilized samples. · Shall detect translucent particles. · Particle Size Range: ≤ 2μm to ≥ 65μm · Sample Analyzed/Volume Dispensed: > 85% · Depth of Field (DOF): ≤ 120μm · Analysis Rate: ≥ 120μl/min The Autosampler shall encompass the following specifications: · Shall integrate with the particle counter to automate washing, rinsing and sample introduction. · Shall be capable of unattended overnight operation. · Shall have liquid sensor to alert operator of short samples. Item 2: Accessories and consumables. The vendor shall supply the following quantities of accessories, consumables, and service. All accessories shall be compatible with the Automated Flow Microscope System offered. · Comprehensive one year service plan; on-site repairs, all parts and labors included, qty = 1 · Autosampler, Fitting, Sample Inlet Port, quantity (qty) = 4 boxes · Cable and Motor Assembly, precision stirrer, qty = 1 · Consumables kit, 3 months, to include tubing, fittings, swabs, and tips, qty = 3 · Flow cell, 100µm, 1.6 mm, qty = 15 · Controller, precision stirrer, qty = 1 · Precision stirrer operation manual, qty = 1 manual · Pipette tips liquid sensing, qty = 6 boxes · Reservoir, 290 mL, single well, qty = 5 boxes · Software license, single, qty = 1 license · NIST certified standards, particle size 10 µm, 15 mL, qty = 3 · NIST certified standards, particle size 15 µm, 15 mL, qty = 3 · NIST certified standards, particle size 1 µm, 15 mL, qty = 3 · NIST certified standards, particle size 25 µm, 15 mL, qty = 3 · NIST certified standards, particle size 2µm, 15 mL, qty = 3 · NIST certified standards, particle size 5 µm, 15 mL, qty = 3 · Particle concentration standard, 10 µm, 25 mL, qty = 4 boxes · Particle concentration standard, 15 µm, 25 mL, qty = 3 boxes · Particle concentration standard, 25 µm, 25 mL, qty = 3 boxes · Particle concentration standard, 2 µm, 25 mL, qty = 4 boxes · Particle concentration standard, 5 µm, 25 mL, qty = 4 boxes · Precision stirrer kit, 10 mL syringe barrel, qty = 2 · Precision stirrer kit, 20 mL syringe barrel, qty = 2 · Precision stirrer kit, 2 mL syringe barrel, qty = 2 · Syringe Guide, 1mL, 10 mL barrel, qty = 1 · Syringe Guide, 2 mL, 10 mL barrel, qty = 1 · Syringe Barrel, Silanized, 10 mL, qty = 4 · Syringe Barrel, Silanized, 20 mL, qty = 4 · Syringe Barrel, Silanized, 2 mL, qty = 4 · Spill Trays, precision stirrer, qty = 2 · Stir rod coupler tubing, qty = 4 boxes · Stir rods, 2 mL barrel, qty = 4 · Stir rods, qty = 4 boxes · Stirrer adaptor, 10 mL barrel, qty = 4 · Stirrer adapter holder, qty = 4 · Stirrer adapter, 20 mL barrel, qty = 4 · Stirrer adapter, 2 mL barrel, qty = 4 · Stopcocks, slip fit, 2 way, qty = 1 box · Well plate, 96 x 1 mL, qty = 5 boxes · Well plate, 96 x 2 mL, qty = 7 boxes Item 3: Delivery, Installation, and On-site training The vendor will cover all costs associated with the following: o System crating, shipping, delivery, set in place, and uncrating. o Full system software and peripheral installation (if applicable). o On-site hardware and software training. o Instrument qualification and operational qualification. o Size and concentration verification. Item 4: Options The vendor will provide a comprehensive service plan for on-site repairs and preventative maintenance to cover the cost of all parts, labor, and travel for option periods 1, 2, 3, and 4. The period of performance for each option year shall be as follows: Period of Performance Start Date Period of Performance End Date Option 1: Preventative Maintenance Service Plan 1 year from award 2 years from award Option 2: Preventative Maintenance Service Plan 2 years from award 3 years from award Option 3: Preventative Maintenance Service Plan 3 years from award 4 years from award Option 4: Preventative Maintenance Service Plan 4 years from award 5 years from award 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 Subvisible particle analysis system and accessories 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 1081 Silver Spring, MD 20993 The robot will be delivered within 90 days of contract award. Installation shall include setup and connection to support utilities necessary to operate the system. The period of performance is estimated to end 12 months post installation and training 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 until September 30 th, 2014. - Response Due Date shall be no later than: February 7th at 1:00 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 opher.McGucken@fda.hhs.gov
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/NCTR/FDA-SOL-1128209/listing.html)
- Record
- SN03273687-W 20140126/140124233949-38bffc25dab2ecdc79c57ca026bda75c (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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