SOURCES SOUGHT
66 -- Microflow Imager
- Notice Date
- 7/27/2011
- Notice Type
- Sources Sought
- NAICS
- 333314
— Optical Instrument and Lens 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
- 1088768
- Archive Date
- 8/20/2011
- 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 notice is for Market Research purposes only, not a request for proposal or solicitation. The Food and Drug Administration (FDA) is seeking sources, including service-disabled veteran-owned small businesses, HUBzone small businesses, 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 contractors for providing the items below. The North American Industry Classification System (NAICS) code is 333314 Optical Instruments and Lens Manufacturing with a small business size standard of 500 employees. Technology to accurately characterize particulates (protein aggregates) in influenza vaccine lots is needed to support distribution of safe vaccines with consistent immunogenicity. This technology is currently not available at the Food and Drug Administration (FDA) /Center for Biologics and Evaluation Research (CBER)/Division of Viral Products who has traditionally facilitated the manufacture of safe and effective seasonal and pandemic flue vaccines. Formulation of aggregates in these vaccines can impact vaccine safety and/or immunogenicity. Imaging-based particle analysis (flow microscopy) offers continuous, microscopic, non-destructive viewing of samples with particle size analysis of aggregates from 1 micron (um) and up. The Microflow Imager (MFI) required to make these measurements should provide consistent and verifiable high sensitivity for measuring near transparent particles in vaccine preparations. Technical Requirements:. Shall include flow microscope, at least 1 flow cell, operating software, analysis software, certified particle standards and start-up consumables.. Shall perform consistently over 1-70 um size range without instrument adjustment. Sizing accuracy shall be at least + or - 5% for particles > or equal to 5 um, + or - 0.5 um for particles < 5 um. Sizing repeatability at 5 um protein standard shall be at least + or - 5% RSD. Concentration accuracy of 5 um protein standard shall be at least + or - 10%. Instrument shall be easy to use; ease of use should include software-controlled focusing, stable optimized optical configuration, ability to view results immediately potential for automated analysis.. Minimal volume needed for application shall be 0.5 ml or less. Sampling efficiency shall be > 85% over complete instrument range. Size resolution shall be 0.25 um or less. Camera pixel density of 1280x1024 or greater; 10-bit grey-scale resolution or greater. Data shall have capacity to export to Excel. Analysis shall include automated as well as user-defined parameters of size and morphology. Software shall have the ability to automatically execute pattern matching functions during image acquisition and provide a particle count and percent by type. Components shall be installed to meet specifications. On-site training shall be complete within 6 weeks of instrument delivery. Shall include 1 year extended warranty for all components and software Potential contractors 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 system that may be contacted by the Government Responses are due in person, by postal mail or by email to the point of contact listed below on or before August 5, 2011 by 1:00 P.M. CDT at the Food and Drug Administration, OC/OA/OAGS, Attn: Marcia Park, 3900 NCTR Road, HFT-322, Jefferson, AR, 72079-9502. Reference 1088768. Questions regarding this posting shall be submitted via email no later than 1:00 P.M. CDT on August 3, 2011. 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 detailed 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 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 a resultant solicitation that may result from this market survey. For information regarding this notice, contact Marcia Park, 870/543-7405, FAX 870543-7990 or email marcia.park@fda.hhs.gov.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/NCTR/1088768/listing.html)
- Place of Performance
- Address: Food and Drug Administration/Center for Biologics, Division of Viral Products, 8800 Rockville Pike, Bethesda, Maryland, 20892, United States
- Zip Code: 20892
- Zip Code: 20892
- Record
- SN02513068-W 20110729/110727235805-97dbb32ba7f0a8b43fbaf23022d9595a (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
| FSG Index | This Issue's Index | Today's FBO Daily Index Page |