SOURCES SOUGHT
99 -- Inline Infrared Process Analytical Technology (PAT) Tool
- Notice Date
- 3/9/2018
- 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 - Rockville, 5630 Fishers Lane, Room 2129, Rockville, Maryland, 20857-0001, United States
- ZIP Code
- 20857-0001
- Solicitation Number
- FDA-SS-1194375
- Archive Date
- 3/17/2018
- Point of Contact
- Priscilla V. Harrison, Phone: 240-402-7609
- E-Mail Address
-
priscilla.harrison@fda.hhs.gov
(priscilla.harrison@fda.hhs.gov)
- Small Business Set-Aside
- Total Small Business
- Description
- TITLE: The Infrared PAT tool for integration with a Vapourtec Flow System OPDIV: FDA, CDER 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 range of nonclinical studies described below from initiation and conduct of the studies through the data analyses phase and preparation of the final reports. 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 recent acquisition of a Continuous Flow Reactor System will allow the FDA to model and gain understanding into how this platform is used in the synthesis of drug substances and drug products. In order to accomplish this, PAT tools are necessary to help establish feedback-feedforward controls over the system. A most valuable PAT tool for this case is an infrared sensor that can be placed in-line to monitor flow streams in real-time. In situ reaction monitoring tracks concentration changes of key reactive and transient species to understand mechanism pathway, determine kinetics and detect major reaction events. The Infrared sensor is designed to study reaction progression and provide specific information about reaction initiation, conversion, intermediates and endpoint. The comprehensive nature of the data makes it ideal for real-time process optimization. Technical Specifications 1. Detector shall operate within an optical range of 4000-650 cm-1 2. Detector shall be compatible and able to integrate easily with Vapourtec's FlowCommander system control software 3. Dimensions shall not exceed 200 mm x 300 mm x 300 mm (W x H x D) 4. Probe pH range shall be at least 1-9 5. Operating range shall be at least 19-25 °C 6. No standalone computer required to operate the detector 7. Shall have USB port for export of data 8. The controller software shall be the latest version. 9. service and technical support during the entire software lifecycle. 10. The entire system shall be warranted for parts and labor for 12 months from the date of installation. 11. Controller software updates shall be furnished at no additional cost during the 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: 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. 10. Responders should also include a statement about whether or not they have an approved Federal audited accounting system. If the responder has an approved accounting system, please provide the certification in which the accounting system was deemed adequate (e.g. the name of the audit agency and audit number). You may submit as an attachment, which will not count towards the overall page limit. 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 2 pages. Responses must be received not later than 9:00 AM (eastern standard time), Friday, March 16, 2018. Capability statements will not be returned and will not be accepted after the due date. Documentation should be emailed to: Priscilla.Harrison@fda.hhs.gov
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/FDA-SS-1194375/listing.html)
- Record
- SN04849822-W 20180311/180309231319-529a1e84a6b4dfcdca10ea20464067f7 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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