SOURCES SOUGHT
66 -- Near Infrared Spectroscopy (Brand Name or Equal)
- Notice Date
- 7/5/2011
- 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, 5630 Fishers Lane, Room 2129, Rockville, Maryland, 20857-0001
- ZIP Code
- 20857-0001
- Solicitation Number
- 1088943
- Archive Date
- 7/30/2011
- Point of Contact
- Natalie Mitchell, Phone: 3018279606
- E-Mail Address
-
natalie.mitchell@fda.hhs.gov
(natalie.mitchell@fda.hhs.gov)
- Small Business Set-Aside
- N/A
- Description
- TITLE OF PROJECT/REQUIREMENT Document Type: Sources Sought Notice Solicitation Number: FDA-SS-11-1088943 Requirement: Near Infrared Spectroscopy Posted Date: 07/05/2011 Original Response Date: 07/15/2011 CONTRACTING OFFICE U.S. Department of Health and Human Services (DHHS) Food and Drug Administration Agency (FDA) / Office of Acquisitions and Grants (OAGs) DESCRIPTION This is a SOURCES SOUGHT NOTICE to determine the availability and capability of small businesses (including certified 8(a), Small Disadvantaged, and HUBZone firms; veteran and service-disabled veteran-owned small businesses, and women-owned small businesses) to supply a real-time, online process Near Infrared Spectroscopy (NIR) system which is needed for DPQR to monitor a pharmaceutical manufacturing process which typically involves liquid and solid phases for both small molecule drugs and biologic drugs. It can provide the chemical and physical information of small molecule drugs and excipients; it can also provide biological properties such as cell viability information in a biotech process, etc. All of these chemical, physical, and biological information are critical for pharmaceutical manufacturing process PAT applications, including in-depth process understanding and process control. The Contractor's capability statement shall demonstrate the company's ability to meet the following requirements. Please provide a detailed description of your company's (including its teammates, if applicable) experience and demonstrated abilities to deliver the specific equipment identified below: REQUIREMENTS: CAPABILITIES: This system will be interfaced with a series of pharmaceutical manufacturing processing equipments for both small molecule drugs and biologic drugs, such as crystallization, high-shear granulator, bioreactor, etc, which are currently available in the Division of Product Quality Research (DPQR). This system must be compatible with those currently available equipments, preferable with no modification of the current available equipments in DPQR. The system must have the following features and capabilities at the least: General Requirements: • A single vendor should manufacture, sell, service and provide technical support for the entire real-time online process Near-infrared Spectroscopy system including interferometer, probe technology and software • Vendor must demonstrate that real-time online process Near-infrared Spectroscopy (NIR) analysis is a core part of their business • The vendor shall have a team with technical expertise specifically in real-time process NIR analysis who are available for consultation without additional cost • The vendor shall be able to provide maintenance services for up to four years Hardware and Sampling Technology Requirements: • It must have capability to monitor pharmaceutical particulate process in situ and in real-time for both small molecule drugs and biologic drugs, eliminating the need for off-line sampling analysis and the associated problems as a result of process perturbation. • The probe tip material must sustain various process environments, which may include organic solvents and some corrosive chemicals. • The probe window should be sapphire. • Available probe outer diameters must be amenable to multiple processing equipment configurations of DPQR without additional charge. • Available probe length must be amenable to multiple processing equipment configurations of DPQR without additional charge. • Wave length range covers at least from 850nm to 2200nm • It has post-dispersive grating • It has fast scan capability to enable real-time online measurement. • NIST traceable standards measured at the sampling plane • It must have capability for analysis of solids, liquids, slurries, and cell suspensions using optimized sampling probe interface (reflectance, transmission, transflectance, flow-cell). • It must have the flexibility for assembling fibers (such as single fiber, microbundle fiber, full bundle fiber) to optimize the measurement conditions (illumination, number of spectra collected, etc.). • It can be Single point analyzer or multiplexer up to 8 sample channels, based on the needs of DPQR. • It must have model transferability between analyzers/probes of the same type. • Vision software package (21 CFR part 11 compliant) which includes everything needed - data acquisition, qualitative method development, quantitative method development and routine analysis - but is user-friendly and easy to us Software Requirements: • The software must be specifically designed for real-time process monitoring. • 21 CFR part 11 compliant • The software must include everything needed - data acquisition, qualitative method development, quantitative method development and routine analysis - but be user-friendly and easy to us with minimal training. • All data analysis functionality should be available in real-time as well as in post process mode • Files should be capable of being saved as Templates that can be applied to subsequent experiment so that analysis does not have to be repeated on every experiment file. • Data treatments to aide in the interpretation of the data (e.g. baseline correction, and profile comparison, etc.) • Integrated quantitative analysis software available with capability to display and analysis the spectra in real-time • Automated and real-time export of spectral data to specified location on local workstation or to intranet • Easy export of all graphical elements to common graphical data formats (e.g. bitmap, metafile) for report generation and publication preparation • Easy export of distributions and trends in common data format for import into spread sheets for further chemometrics analysis. • Backwards compatibility to analyze data collected with older software versions from the same manufacturer • Capable to import off-line analytical data to scale and quantify profiles • Low cost software maintenance agreement available to include automatic upgrades to future software revisions • Running under Windows XP or Vista operating systems with all service pack versions • OPC compatible • Other user-specific data analysis capability based on project need within one year of receiving of the system, without additional charge applied to DPQR. Interested small business potential offerors are encouraged to respond to this notice. However, be advised that generic capability statements are not sufficient for effective evaluation of respondents' capacity and capability to deliver the specific equipment as required. Responses must directly demonstrate the company's capability, experience, and/or ability to supply the Real Time Online Process Near Infrared Spectroscopy to meet all of the above specifications; and evidence that the contractor can satisfy the general requirements listed above while in compliance with FAR 52.219-14 ("Limitations on Subcontracting"). Failure to definitively address each of these factors will result in a finding that respondent lacks capability to perform the work. Responses to this notice shall be limited to 5 pages, and must include: 1. Company name, mailing address, e-mail address, telephone and FAX numbers, website address (if available), and the name, telephone number, and e-mail address of a point of contact having the authority and knowledge to clarify responses with Government representatives. 2. Name, title, telephone number, and e-mail addresses of individuals who can verify the demonstrated capabilities identified in the responses. 3. Business size for NAICS 334516 (size standard $ or number of employees) and status, if qualified as an 8(a) firm (must be certified by SBA), Small Disadvantaged Business (must be certified by SBA), Woman-Owned Small Business, HUBZone firm (must be certified by SBA), and/or Service-Disabled Veteran-Owned Small Business (must be listed in the VetBiz Vendor Information Pages). 4. DUNS number, CAGE Code, Tax Identification Number, and company structure (Corporation, LLC, partnership, joint venture, etc.). Companies also must be registered in the Central Contractor Registry (CCR, at www.ccr.gov) to be considered as potential sources. 5. If applicable, identification of the firm's GSA Schedule contract(s) by Schedule number and contract number and SINs that are applicable to this potential requirement are also requested. 6. If the company has a Government approved accounting system, please identify the agency that approved the system. Please submit copies of any documentation such as letters or certificates to indicate the firm's status (see item #3, above). Teaming arrangements are acceptable, and the information required above on the company responding to this announcement, should also be provided for each entity expected to be teammates of the respondent for performance of this work. To the maximum extent possible, please submit non-proprietary information. Any proprietary information submitted should be identified as such and will be properly protected from disclosure. This notice is for planning purposes only, and does not constitute an Invitation for Bids, a Request for Proposals, a Solicitation, a Request for Quotes, or an indication the Government will contract for the items contained in this announcement. This request is not to be construed as a commitment on the part of the Government to award a contract, nor does the Government intend to pay for any information submitted as a result of this request. The Government will not reimburse respondents for any cost associated with submission of the information being requested or reimburse expenses incurred to interested parties for responses to this announcement. Responses to this notice must be received via email to Contract Specialist Natalie Mitchell at email address Natalie.mitchell@fda.hhs.gov no later than 4:00 PM Eastern Standard time on Friday, July 15, 2011 for consideration. Responses to this announcement will not be returned, nor there any ensuing discussions or debriefings of any responses. However, information obtained as a result of this announcement may be reflected in the subsequent solicitation, and the FDA may contact one or more respondents for clarifications and to enhance the Governments understanding. This announcement is Government market research, and may result in revisions in both its requirements and its acquisition strategy based on industry responses.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/1088943/listing.html)
- Place of Performance
- Address: FDA, White Oak Campus, 10903 New Hampshire Avenue, WO Building 62 Loading Dock, Silver Spring, Maryland, 20903, United States
- Zip Code: 20903
- Zip Code: 20903
- Record
- SN02489316-W 20110707/110705234141-860bfb93f3535cf466f6483272815cbd (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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