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FBO DAILY ISSUE OF MARCH 25, 2011 FBO #3408
SOURCES SOUGHT

66 -- NIR+Raman integrated Spectrometer

Notice Date
3/23/2011
 
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, Bldg 50 Room 422, Jefferson, Arkansas, 72079, United States
 
ZIP Code
72079
 
Solicitation Number
1085901
 
Archive Date
4/16/2011
 
Point of Contact
Marcia O Park, Phone: (870) 543-7405
 
E-Mail Address
marcia.park@fda.hhs.gov
(marcia.park@fda.hhs.gov)
 
Small Business Set-Aside
N/A
 
Description
This is for Market Research purposes only, not a request for proposal or solicitation. The Food and Drug Administration, is seeking sources, including service-disabled veteran-owned small businesses, HUBzone small businesses, 8(a) certified businesses as well as small businesses. The following information is provided to assist the FDA in conducting Market Research to identify potential contractors for providing the equipment described below. The Division of Product Quality Research (DPQR) at the National Center for Toxicological Research in Jefferson, AR requires a Near-Infrared (NIR)/Raman Combination Spectrometer with automatic switching between the two instruments, equipped with multiplexed custom probes for in situ monitoring of protein therapeutic products during the lyophilization cycle. Due to the phase transition of the formulation from liquid to frozen, and finally a dry cake structure, it is essential to monitor changes in the system to understand subtle changes that occur during the process. Near-Infrared alone is not suitable for liquid systems, because water bands can interfere with interpretation, therefore Raman is needed as a complimentary tool to monitor the process during the initial phase from liquid to frozen solid. The two techniques will work to complement each other during the remainder of the cycle to monitor moisture content and other important chemical and physical changes. The government is seeking capability statements from small manufacturing companies that can provide an instrument with salient characteristics as listed.. NIR+Raman integrated spectrometer for online process monitoring of freeze dried pharmaceuticals. The System must be a turnkey solution incorporating optics, mechanics, electronics and software.. NIR+Raman Spectromter. NIR Wavelength 1.3 um (7000 cm-1) to 2.2 um (4500 cm-1). Raman 785 nm excitation - covers 300 cm-1 to 3200 cm-1. An automated Switching mechanism from NIR to Raman mode. Optical Switches: Capable of being at least 10 feet from the main instrument. Raman - one optical switch controlling up to 4 fiber optic probes. Near Infrared - one optical switch controlling up to 4 fiber optic probes. Probes: Stainless steel construction, capable of fitting into a 20 mm diameter vial, less than 2.5 inches in length, with NIR and Raman coupled together for sampling of the same vial. Modification of existing rubber stoppers to fit the probes through to the sample.. Raman - At least 2, up to 4 probes. NIR - At least 2, up to 4 probes. Software. Windows-based software package with flexible data acquisition, processing and output functionalities. Optional:. Additional Switches for 1 x 8 NIR and Raman (1 for each), within 1 year of acquisition. Up to 6 additional custom NIR Probes, within 1 year of acquisition. Up to 6 additional custom Raman Probes, within 1 year of acquisition. OPC Licenses and Hardware necessary for communication with external equipment to make real time processing decisions, within 1 year of acquisition The associated North American Industry Classification System (NAICS) code is 334516 - Analytical Laboratory Instrument Manufacturing; Small business size standard is 500 employees. Potential contractors must provide: (1) Company contact information, which at a minimum shall include company name, company physical and mailing addresses, company point of contact with phone number, fax number, and email address; (2) Company DUNS Number and CAGE Code; (3) Socioeconomic size status under the aforementioned NAICS/Size Standard, i.e., large business, small business, veteran-owned small business, service-disabled veteran-owned small business, HUBZone small business, small disadvantaged business, woman-owned small business, 8(a) small business (the Government will verify against annual certifications at https://orca.bpn.gov/ and as such respondents should make sure their representation and certifications are current); (4) GSA Schedule or Other Federal Contract Vehicles under which this technology may be acquired to include; and (5) Capability statement identifying core competencies related to this requirement, a detailed description of recent prior experience manufacturing or otherwise integrating same or very similar technologies to include client name and current contact information sufficient for the Government to verify the work performed, and technical specifications, descriptive material, literature, brochures and other information which clearly demonstrates the capabilities of the contractor to meet this specific requirement. Responses are due in person, by postal mail or email to the point of contact listed below on or before April 1, 2011 by 1:00 CDT at the Food and Drug Administration, OC/OA/OAGS, Attn: Marcia Park, 3900 NCTR Road, HFT-320, Jefferson, AR 72079-9502. Reference 1085901. This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by the respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detained to allow the Government to determine the organization's qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published in the Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation. No proprietary, classified, confidential or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation that may result from this market survey. For information regarding this notice, contact Marcia Park, 870/543-7405, Fax 870/543-7990 or email marcia.park@fda.hhs.gov. This is for Market Research purposes only, not a request for proposal or solicitation. The Food and Drug Administration, is seeking sources, including service-disabled veteran-owned small businesses, HUBzone small businesses, 8(a) certified businesses as well as small businesses. The following information is provided to assist the FDA in conducting Market Research to identify potential contractors for providing the equipment described below. The Division of Product Quality Research (DPQR) at the National Center for Toxicological Research in Jefferson, AR requires a Near-Infrared (NIR)/Raman Combination Spectrometer with automatic switching between the two instruments, equipped with multiplexed custom probes for in situ monitoring of protein therapeutic products during the lyophilization cycle. Due to the phase transition of the formulation from liquid to frozen, and finally a dry cake structure, it is essential to monitor changes in the system to understand subtle changes that occur during the process. Near-Infrared alone is not suitable for liquid systems, because water bands can interfere with interpretation, therefore Raman is needed as a complimentary tool to monitor the process during the initial phase from liquid to frozen solid. The two techniques will work to complement each other during the remainder of the cycle to monitor moisture content and other important chemical and physical changes. The government is seeking capability statements from small manufacturing companies that can provide an instrument with salient characteristics as listed.. NIR+Raman integrated spectrometer for online process monitoring of freeze dried pharmaceuticals. The System must be a turnkey solution incorporating optics, mechanics, electronics and software.. NIR+Raman Spectromter. NIR Wavelength 1.3 um (7000 cm-1) to 2.2 um (4500 cm-1). Raman 785 nm excitation - covers 300 cm-1 to 3200 cm-1. An automated Switching mechanism from NIR to Raman mode. Optical Switches: Capable of being at least 10 feet from the main instrument. Raman - one optical switch controlling up to 4 fiber optic probes. Near Infrared - one optical switch controlling up to 4 fiber optic probes. Probes: Stainless steel construction, capable of fitting into a 20 mm diameter vial, less than 2.5 inches in length, with NIR and Raman coupled together for sampling of the same vial. Modification of existing rubber stoppers to fit the probes through to the sample.. Raman - At least 2, up to 4 probes. NIR - At least 2, up to 4 probes. Software. Windows-based software package with flexible data acquisition, processing and output functionalities. Optional:. Additional Switches for 1 x 8 NIR and Raman (1 for each), within 1 year of acquisition. Up to 6 additional custom NIR Probes, within 1 year of acquisition. Up to 6 additional custom Raman Probes, within 1 year of acquisition. OPC Licenses and Hardware necessary for communication with external equipment to make real time processing decisions, within 1 year of acquisition The associated North American Industry Classification System (NAICS) code is 334516 - Analytical Laboratory Instrument Manufacturing; Small business size standard is 500 employees. Potential contractors must provide: (1) Company contact information, which at a minimum shall include company name, company physical and mailing addresses, company point of contact with phone number, fax number, and email address; (2) Company DUNS Number and CAGE Code; (3) Socioeconomic size status under the aforementioned NAICS/Size Standard, i.e., large business, small business, veteran-owned small business, service-disabled veteran-owned small business, HUBZone small business, small disadvantaged business, woman-owned small business, 8(a) small business (the Government will verify against annual certifications at https://orca.bpn.gov/ and as such respondents should make sure their representation and certifications are current); (4) GSA Schedule or Other Federal Contract Vehicles under which this technology may be acquired to include; and (5) Capability statement identifying core competencies related to this requirement, a detailed description of recent prior experience manufacturing or otherwise integrating same or very similar technologies to include client name and current contact information sufficient for the Government to verify the work performed, and technical specifications, descriptive material, literature, brochures and other information which clearly demonstrates the capabilities of the contractor to meet this specific requirement. Responses are due in person, by postal mail or email to the point of contact listed below on or before April 1, 2011 by 1:00 CDT at the Food and Drug Administration, OC/OA/OAGS, Attn: Marcia Park, 3900 NCTR Road, HFT-320, Jefferson, AR 72079-9502. Reference 1085901. This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by the respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detained to allow the Government to determine the organization's qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published in the Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation. No proprietary, classified, confidential or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation that may result from this market survey. For information regarding this notice, contact Marcia Park, 870/543-7405, Fax 870/543-7990 or email marcia.park@fda.hhs.gov.
 
Web Link
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/NCTR/1085901/listing.html)
 
Place of Performance
Address: The US Food and Drug Administration, White Oak Campus, 10903 New Hampshire Avenue, WO Building 62 Loading Dock, Silver Spring, Maryland, 20993, United States
Zip Code: 20993
 
Record
SN02407362-W 20110325/110323234339-c3cf17b75b06ce6b20b7ea3f6288a269 (fbodaily.com)
 
Source
FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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