SOLICITATION NOTICE
66 -- Near Infrared Spectroscopy (Brand Name or Equal)
- Notice Date
- 7/26/2011
- Notice Type
- Cancellation
- NAICS
- 334515
— Instrument Manufacturing for Measuring and Testing Electricity and Electrical Signals
- 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
- FDA-SOL-1088943
- Archive Date
- 8/16/2011
- 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
- GENERAL REQUIREMENTS: ****SUBJECT TO THE AVAILABILTY OF FUNDS**** ****Quotes must be valid through September 30, 2011**** 1. 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. 2. Installation • Components should be installed to meet specifications as written in bid response and must be met after any service visits 3. Warranty • Shall include 1 year extended warranty or base (one year from date of delivery/installation) for all components and software. 4. Options • Shall include 4 additional years parts and service (after the initial year warranty) for all components and software listed as follows: Option 1 Option 2 Option 3 Option 4 5. Deliverables • Contractor shall deliver and install to specifications, set up analytical software and provide warranty and training in instrumentation and analysis.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/FDA-SOL-1088943/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, 20903, United States
- Zip Code: 20903
- Zip Code: 20903
- Record
- SN02511340-W 20110728/110726235823-21efdc6cb3b1f154f0d65011dbf3f72c (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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