SOURCES SOUGHT
66 -- Stability Chambers, Water Systems, and Warranty
- Notice Date
- 1/27/2014
- 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-1129370
- Archive Date
- 2/25/2014
- 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: Stability Chambers, Water System, and Warranty 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 Five (5) stability chambers with accessories are required for the FDA Division of Product Quality Research (DPQR) to carry out its mission critical laboratory research. The Stability chambers and accessories will enable DPQR to provide evidence on how the quality of a pharmaceutical drug product varies with the time under the influence of environmental factors. CONTRACTOR REQUIREMENTS Respondent Contractors shall be able to provide the following items with the salient characteristics listed below: Item 1: Five (5) Stability Chambers: The five (5) stability chambers shall meet these technical specifications: · Shall have an adjustable temperature range of ≤ 5 °C to ≥ 40 °C. · Shall have an adjustable relative humidity (RH) range of ≤ 20% to ≥ 75 % · Shall have an interior volume ≥ 33 cubic feet. · Shelves: a minimum of 8 shelves shall be included with a maximum capacity of ≥ 12 shelves for each stability chamber. · Exterior dimensions shall not exceed 41W x 36D x 92H (inches) · NEMA plug, cord, and receptacle shall be included with each unit. · Shall conform to the FDA 21 CFR 11 requirements for data recording, audit trails of controller settings modification, alarm history logs, operator event logs and file transfers. Operating data, e.g., temperature, relative humidity, is stored in user defined time length log files and can be viewed on the touchscreen, or remotely by PC. · Shall have interface USB port for data transfer to printer or removable memory stick to maintain local paper trail requirements. The removable memory stick allows export and import of profiles, alarm files, audit trail files, and other data files. File utilities are available with a paperless recording capability. · Electrical requirements: 208-230V, ≤ 30Amp. Item 2: Water System · A deionized water system shall be provided for at least two (2) of the requested five (5) units in order to meet the water requirements for the stability chamber’s humidifier. Item 3: Warranty and installation: · All equipment shall have a warranty. To include parts and labor, for at least one year. Item 4: Delivery and Installation: · Delivery and installation for each stability chamber shall be included with purchase. The service will include uncrating, removal of debris, and the “set-in-place” for each chamber. Item 5: (Optional) Preventative Maintenance and Calibration Service Options The contractor shall provide preventative maintenance service for option period one (1) beyond the initial one year warranty period. 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 12:00 PM Noon EST, February 10 th, 2014. 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-1129370/listing.html)
- Record
- SN03275211-W 20140129/140127234636-a4c2fdef9bdc82ce9556aa2d505bfcd5 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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