SOURCES SOUGHT
66 -- NIR/Raman Combination Spectromter
- Notice Date
- 3/21/2012
- 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
- 1100747
- Archive Date
- 4/19/2012
- 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 notice is for Market Research purposes only, not a request for quotations or solicitation. The Food and Drug Administration (FDA) is seeking sources, including service-disabled veteran-owned small businesses, HUBzone small business, 8(a) certified small businesses, woman owned small businesses, small disadvantaged businesses as well as small businesses. The following information is provided to assist the FDA in conducting Market Research to identify potential small businesses for providing the items below. All parties may respond to this synopsis. Reference #1100747 when responding The North American Industry Classification System (NAICS) code is 334516 - Analytical Laboratory Instrument Manufacturing with a small business size standard of 500 employees. Project Background The Food and Drug Administration, Center for Drug Evaluation and Research, Division of Product Quality Research (FDA/CDER/DPQR) requires a Near Infrared (NIR)/Raman Combination spectrometer with automatic switching between the two instruments, equipped with multiplex 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 isi 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 companies that can provide a small business manufactured instrument with salient characteristics as listed..NIR+Raman Spectrometer.NIR Wavelength 1.3 um (7000 cm-1) to 2.2 um (4500 cm-1), deep cooled detector to -55 degrees centigrade, without the use of liquid nitrogen.Raman 785 nm excitation, 500 mW or greater - covers 300 cm-1 to 3200 cm-1, deep cooled detector to -55 degrees centigrade, without the use of liquid nitrogen. 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: Autoclavable Stainless steel construction, capable of fitting into a 20 mm diameter vial, less than 2 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 without being crushed during vial stoppering. Modification of stainless steel port and tri-clamp to allow fiber optic lines into the lyophilizer. Probes must be able to withstand vacuum down to 35mTorr and pressurization up to 30 Psi, and temperatures between minus 45 degrees centigrade and 60 degrees centigrade..Raman - at least 4, up to 8 probes.NIR - At least 4, up to 8 probes. Data Acquisition and Analysis Windows-based software package with flexible data acquisition, processing and output functionalities Data station for instrument operation and data analysis and other necessary accessories 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. Optional out year maintenance years will be required after expiration of warranty period. Installation of instrument to be at FDA White Oak Campus, 10903 New Hampshire Avenue, Silver Spring, MD. Funding for this project is contingent upon the availability of Fiscal Year 2012 funds. Potential offerors must indicate business size, proof of any set-aside certification and company's DUNS number and provide a contact name, the mailing address, phone number and email address of point of contact. Capability statement must provide enough information to determine if company can meet requirements stated above by including technical specifications, descriptive literature, brochures and other information that demonstrates the capabilities of the contractor to meet the requirements. Provide two contact names, email and phone numbers for user of the proposed product that may be contacted by the Government. Identify availability under GSA contract if applicable. Potential contractors proposing a product manufactured by a small business must certify that the product is manufactured by a small business and provide the name and DUNS number of that small business manufacturer. Though not required, informational pricing would be appreciated. Responses are due in person, by postal mail or by email to the point of contact listed below on or before April 4, 2012 by 1:00 P.M. CST at the Food and Drug Administration, OC/OA/OAGS, Attn: Marcia Park, 3900 NCTR Road, HFT-322, Jefferson, AR 72079-9502. Reference 1100747. Questions regarding this posting shall be submitted via email to Marcia Park at Marcia.park@fda.hhs.gov no later than 1:00 P.M. CST on March 30, 2012. 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 user information provided by the respondents for any purpose deemed necessary and legally appropriate. Any firm responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications to provide the product specified. Respondents are advised 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 solicitation may be published via FedBizOps.Gov. 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 a 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/1100747/listing.html)
- Place of Performance
- Address: 10903 New Hampshire Street, Silver Spring, Maryland, 20993, United States
- Zip Code: 20993
- Zip Code: 20993
- Record
- SN02702047-W 20120323/120321235114-73ae93d3804e84cd92ed7037e0e05a22 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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