SOURCES SOUGHT
70 -- Automated Titration System - FDA 1149417
- Notice Date
- 5/12/2015
- 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, 5630 Fishers Lane, Room 2129, Rockville, Maryland, 20857-0001
- ZIP Code
- 20857-0001
- Solicitation Number
- FDA-1149417
- Point of Contact
- Telisha Wilson, Phone: 2404027572
- E-Mail Address
-
telisha.wilson@fda.hhs.gov
(telisha.wilson@fda.hhs.gov)
- Small Business Set-Aside
- N/A
- Description
- TITLE: Sources Sought Notice FDA SS-1149417 TITLE: Sources Sought Notice FDA SS-1149417 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. The North American Industry Classification System (NAICS) code for the proposed acquisition is 334516, Analytical Laboratory Instrument Manufacturing, with a small business size standard of 500 employees. 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 Food and Drug Administration's Office of Acquisitions and Grants Services has a requirement for Automated Titration System for replacement of a defect instrument with a 12 month warranty from date of installment. Titration is an established laboratory method for quantitative analysis of pharmaceuticals. The United States Pharmacopoeia describes several titrimetric methods to assess the compliance of pharmaceutical products. Titrimetric assays are used for the quantification of major components of bulk drug substances or active ingredients in finished pharmaceutical products. Automated titration systems allow users to perform unattended fast and reliable titrations of samples. Technical Requirements are as follows: • An automated titrator for general titration purposes, including acid/base and potentiometric titrations, is required. The instrument should allow for fully automated titration of samples using preprogrammed and customized methods. • Titrator with terminal, pH board, integrated burette drive and magnetic stirrer • Manual titration stand, expandable to be used with automated titration stand • Liquid handler for automated dosing and pipetting of liquids • 2 x 10 mL burettes • pH electrode • USB Interface • USB Printer • Expandable to utilize additional titration or dosing burettes and sensing boards • Data management and documentation of results via connection to PC titration software • Shall not be a standalone instrument/ mass spectrometer • Shall interface with Thermo Q-Exactive Orbitrap Mass Spectrometer • Shall connect with IMS drift tube with Thermo source inlet • Shall interface with Thermo CTC Autosamplers • Instrument control electronics and software shall be included • Control of IMS instrument shall be within mass spectrometer control software (XCalibur) • Shall be compatible with existing source /ionization modules • Shall include the Thermal Desorber and Corona Discharge Ionization Module Trade and Service Specifications: • The instrument must be a newly manufactured unit, not used and refurbished or previously used for demonstration. The life cycle of this instrument is intended to be greater than ten years at full performance. CDER must be able to reasonable expect service and technical support from the vendor during its lifecycle. • The entire system must be warranted for parts and labor for 12 months from the date of installation. The vendor shall provide a copy and pricing for any available extended warranties and service contracts. The vendor must also be capable of servicing the instrument through the extended warranty or service contract. This information shall not obligate CDER to purchase an extended warranty. • The vendor must demonstrate the ability to manufacture the instrument system with a high degree of quality control as evidenced by units in use by other customers performing applications with similar technical demands. Task 2 - Installation Qualification & Operational Qualification • IQ/OQ and PQ shall be performed and documented by the vendor during installation of the instrument. Task 3 - Training • The vendor should be able to perform instrument installation and provide basic training within three working days. Three or four DPA chemists will receive the training. Task 4 - Removel of existing Titrator as trade in • The vendor shall accept the existing Titrator as a trade-in and remove it from the property Model Number: Mettler Toledo Excellence Titrator T70 Serial Number: Serial Number 5129350085 Delivery Location: Food & Drug Administration 645 S. Newstead Avenue St. Louis, MO 63110 Please provide the follow Business information: 1. DUNS Number 2. Company Name 3. Company Address. 4. Company Point of Contact, phone number and email address 5. 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. 6. Corporate structure (corporation, LLC, sole proprietorship, partnership, limited liability partnership, professional corporation, etc.); 7. Current GSA Schedules appropriate to this Sources Sought 8. Current Government Wide Agency Contracts (GWACs) 9. 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 provide the stated requirements may submit capability statements via email or regular mail to the point of contact listed below. Responses must be received not later than 3:00 PM EST, May 25, 2015. Capability statements will not be returned and will not be accepted after the due date. Documentation should be emailed to: Telisha.Wilson@fda.hhs.gov with subject line titled "Sources Sought 1149417".
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/FDA-1149417/listing.html)
- Record
- SN03728160-W 20150514/150512235428-7e2ecd9bc64b1d91958a9c32ff413691 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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