SOURCES SOUGHT
66 -- Sources Sought- Micro Fluid Imaging System
- 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-1128209
- 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: Subvisible Particle Analysis System 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 Division of Product Quality Research (DPQR) is requesting 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. CONTRACTOR REQUIREMENTS Contractors must respond to all of the following points by describing your experience and capabilities in supplying the requirement below: 1 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: · Image, count, and size particles in liquid formulations. · Distinguish silicone oil droplets from aggregates. · Characterize and quantify particles after reconstituting lyophilized samples. · 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: · Integrate with the particle counter to automate washing, rinsing and sample introduction. · Capable of unattended overnight operation. · 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: · 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. 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-1128209/listing.html)
- Place of Performance
- Address: 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
- SN03251560-W 20131215/131213234432-e15f0769f12aae5b30b91ea2c7f2fc3f (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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