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FBO DAILY - FEDBIZOPPS ISSUE OF FEBRUARY 27, 2014 FBO #4478
SOURCES SOUGHT

66 -- Sources Sought: SEM-Ramen System

Notice Date
2/25/2014
 
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
FDA-SS14-1130109
 
Archive Date
3/22/2014
 
Point of Contact
Christopher R. McGucken, Phone: 3018277161
 
E-Mail Address
christopher.mcgucken@fda.hhs.gov
(christopher.mcgucken@fda.hhs.gov)
 
Small Business Set-Aside
N/A
 
Description
TITLE: SEM-Ramen System OPDIV: FDA, Center for Drug Evaluation and Research This is a SOURCES SOUGHT NOTICE to determine the availability of potential small businesses (e.g., 8(a), service-disabled veteran owned small business, HUBZone small business, small disadvantaged business, veteran-owned small business, and women-owned small business) in accordance with FAR 7.104(d). The potential small business will need to demonstrate the capability to perform all facets of the work described below. The sole intent of this Sources Sought Notice is to obtain capabilities for set-aside and procurement planning purposes. This is not an invitation for bid, request for proposal, or other solicitation, and in no way obligates the Food and Drug Administration (FDA) to award a contract. BACKGROUND The Food and Drug Administration’s Center for Drug Evaluation and Research is seeking an SEM-Raman to detect and characterize crystallization of innovator transdermal drug delivery systems and their generic counterparts, determine the normal lot-to-lot variability in an innovator's product and examine the corresponding generic product to identify unique differences or common characteristics, establish levels of crystallization in transdermal drug delivery systems that are currently marketed in the United States, to provide a method to evaluate crystal growth in marketed products, and to provide FDA review scientists with data that can be used to establish appropriate limitations of crystals in applications. CONTRACTOR REQUIREMENTS Respondent Contractors shall be able to provide: One (1) Raman System with Interface for a coupled SEM-Ramen System, that at a minimum can meet the following requirements: 1. Design of the confocal Raman microscope system is to be customized by the vendor prior to delivery such that it will interface with the selected scanning electron microscope and that that no additional “field” modifications are required. The Raman system interface should be permanently mounted onto the SEM with fully retractable Raman optics (i.e., the Raman collection optics should retract when not in use so the general purpose capabilities of the SEM are not compromised). The interface permits simultaneous secondary electron imaging and Raman spectroscopy inside an SEM chamber making chemical analysis possible within the SEM. The combined system must be able to produce the Raman spectrum, SEM image and EDX spectrum from the same 1–2 micron region of the specimen. All optics and mechanisms in the tandem system can be optimized automatically. Built-in computer-controlled video camera. Integrated computer-controlled white light illumination. 2. The Raman microscope system together with lasers should be fitted to a rigid honeycomb anti-vibration base plate to minimize environmental vibration pickup. The components should all be kinematically mounted to ensure precise reinstallation following removal for servicing. 3. Spectrometer. The instrument supplied should be a combined microprobe-microscope capable of producing Raman spectra. Deep depleted large format charge coupled device (CCD) array; Peltier cooled to -60C; detector range from 400 nm to 1060 nm. It should reject the Rayleigh scattering from the return beam. Spectra should be acquired via a single-grating path spectrograph of 250 mm focal length, with 1200 groove/mm gratings, which should employ on-axis refractive optics in a stigmatic design. The angle of the grating should be controlled with a motor using encoder feedback control for accuracy better than 0.2cm -1 over 10,000cm -1 and repeatability better than 0.2 cm -1 over the full spectral range. There should be an option for multiple gratings. Scan to scan repeatability should be better than 0.05 cm -1. The instrument should be able to provide spectral scans as well as rapid, single wavenumber imaging. The following features are required: a. Optimized for excitation at 514.5, 633, 785 and 830 nm with other wavelengths being available (e.g., 532, 244, 257, 325 nm). The system should offer the possibility for fully optimized optical performance by making use of kinematically mounted lens sets to cover the full UV to NIR spectral regions. b. Spectral resolution better than 0.5 cm -1 in the visible region of the spectrum (grating dependent) using the 250 mm focal length spectrograph. Longer focal length spectrographs are unacceptable owing to the reduced sensitivity/throughput. c. Spectral coverage from -1000 to 9000 cm -1 in a single, continuous acquisition with resolution better than 3 cm -1 is required (514.5 nm excitation). Spectral stitching after collection of multiple exposures is unacceptable owing to problems associated with spectral mismatch at the joining point. Resolution should be variable via on-chip binning. d. CCD specification should offer options for UV coated and a deep depletion chip for optimized UV and NIR operation. The readout noise must be less than 7 electron/pixel and dark current less than 0.02 and 0.001 electrons/pixel/second (chip dependent). Back-thinned chips and liquid nitrogen cooling are unacceptable owing to problems of fringing in the spectra and the need to use liquefied coolants. The chip dimensions should be ca 400 x 600 pixels to provide the possibility for direct 2-dimensional imaging using high throughput angle tuned dielectric filters. Larger chip sizes (e.g., 1” diameter, 256 x 1024 pixels) are unacceptable owing to spectral distortions. e. The system should provide a confocal resolution of better than 2.0 µm when using 100x objective lens. The confocal arrangement should use a combination of the spectrograph slit and the active CCD area to obtain optimum performance as opposed to a pinhole which could lead to stability and focusing problems over a wide range of laser exciting wavelengths. 4. Automation. The system should be fully automated, including functionality for self alignment and self validation without the need for operator intervention. The functions should be software controlled and return the system to fully optimized performance. These operations should be available for all visible laser wavelengths and should include the functionality for automated Rayleigh filter, diffraction grating and confocal performance where selected. There should be facility to mount a minimum of four selectable Rayleigh filters. There should be built into the system the following self validation and calibration features, mixed gas calibration lamp, white light for absolute intensity correction and internal reference sample for full system performance validation. Simple motorization is unacceptable owing a lack of feed back for optimized system performance. 5. Microscope. A free standing research grade confocal microscope is required which is kinematically mounted onto the system base plate and directly couples to the Raman spectrometer using a fully collimated laser beam which requires no intermediate optics. Infinity corrected objectives should be provided with 5x, 20x, 50x, and 100x magnification. A color video camera and eyepieces should be fitted into the microscope, with color video image capture card for video-on-PC. There should be automated white light/laser light switching. XYZ mapping stage using encoder motor control with repeatability of 0.2 micron in 0.1 micron steps over the full operating range. Integrated software for line, depth scans, fully flexible area and volume measurements with full auto focusing capability. 250 nm spatial resolution (X/Y) and 1 micron depth resolution (Z). 5.0 megapixel 14-bit CCD USB 2.0 camera with 2448 X 2048 resolution and on-board processing. Aluminum slide pack. Tool kit. Sampling holding kit for motorized XYZ stage. Class 1 microscope enclosure. 6. Lasers. 300 mW at 785 nm source. The instrument should use air-cooled lasers externally mounted for easy access and kinematically mounted onto the system base plate of the Raman instrument. It is unacceptable to have lasers built into the Raman system since this requires the operator to enter the spectrometer to make access which can lead to a degradation in system performance. In addition, internal lasers may generate heat inside the spectrometer leading to performance instability. Class 1. Laser power meter. 7. Accessories and upgrades should be available either at the time of purchase or as later add-ons. The upgrades must be fully modular in nature and should be carried out on the customer site. a. Provision for line focusing accessory for simultaneous collection of line spectra. The provision of a laser spot rastering facility is not acceptable since it does not reduce the laser power density over the sample area thereby increasing the likelihood of laser induced sample damage. b. Provision of line focusing accessory for simultaneous collection of line spectra for rapid Raman imaging with spectral data collection times in the millisecond time scale. The movement of the Raman signal on the CCD and the motorized xy stage much be synchronized to ensure that the minimum overhead for the experiment is incurred. Return of the unit to the manufacturing site for installation of this accessory is unacceptable. c. Objective for measurement of larger samples, and to reflect the laser beam through 90° to allow measurement of samples difficult to place under the microscope. d. The system should be upgradeable to accept the following alternative microscopes. The items listed can either be used in isolation or all together on the same Raman system. i. Free space microscope. This should be fitted as well as the usual metallurgical microscope used with the system. Subsequent addition of this accessory should be accomplished without any alteration to the overall system. ii. AFM/NSOM. Subsequent addition of this accessory should be directly coupled to the standard Raman microscope and not require additional hardware modifications and without comprising the performance of the individual systems. Any alignment or physical adaptation of either system is unacceptable since inferior performance will be observed. Integrated software should be available to ensure seamless control of the two systems. iii. Confocal fluorescence microscope. This should be fitted as well as the usual metallurgical microscope used with the system. There should be no need to make any alignment of lasers or Raman emissions to ensure optimum performance. Subsequent addition of this accessory should be accomplished without any alteration to the overall system. iv. Inverted microscope for biological samples 8. Vendor shall supply all software to utilize the instruments in a portable format to be installed on DPA-supplied Windows 7 (64 bit) PC at the time of instrument installation. 9. Raman system shall be delivered within 3 months following award of contract with all necessary supplies and accessories required for the installation and start-up. Installation, IQ/OQ and on-site training must be included in quoted price and must occur within 30 days following delivery of instrument. 10. Optical table including supports. Table individually optimized, tested, and shipped with test data certificate. 11. Support life of the parts and service for the instrument should be at least 10 years. 12. At least one year parts and labor from date of successful IQ/OQ completion. II. Trade and Service Criteria The instrument must be a newly manufactured unit, not used and refurbished or previously used for demonstration. The life cycle of this instrument is intended to be greater than ten years at full performance. CDER must be able to reasonable expect service and technical support from the vendor during its lifecycle. The entire system must be warranted for parts and labor for 12 months from the date of installation. Software updates to be furnished at no additional cost during the warranty period. Technical support to be furnished at no additional cost during the warranty period. The vendor shall provide a copy and pricing for any available extended warranties and service contracts. The vendor must also be capable of servicing the instrument through the extended warranty or service contract. The vendor must demonstrate the ability to manufacture the instrument system with a high degree of quality control as evidenced by units in use by other customers performing applications with similar technical demands. Capability statements must demonstrate the minimum requirements outlined above. Please address each in the order listed above and include any product sheets for the proposed system. Please provide the follow Business information: DUNS Number Company Name Company Address. Company Point of Contact, phone number and email address Type of company under NAICS, as validated via the System for Award Management (SAM). Additional information on NAICS codes can be found at www.sba.gov. Any potential government contract must be registered on the SAM located at http://www.sam.gov/index.asp. Corporate structure (corporation, LLC, sole proprietorship, partnership, limited liability partnership, professional corporation, etc.); Current GSA Schedules appropriate to this Sources Sought Current Government Wide Agency Contracts (GWACs) Point of Contact, phone number and email address of individuals who can verify the demonstrated capabilities identified in the responses. Interested parties having the capabilities necessary to perform the stated requirements may submit capability statements via email or regular mail to the point of contact listed below. Responses shall be limited to 25 pages. Responses must be received not later 3:00 PM EST, March 7th, 2014. Capability statements will not be returned and will not be accepted after the due date. Documentation should be emailed to: Christopher.McGucken@fda.hhs.gov
 
Web Link
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/FDA-SS14-1130109/listing.html)
 
Place of Performance
Address: Food and Drug Administration, 645 South Newstead, St Louis, Missouri, 63110, United States
Zip Code: 63110
 
Record
SN03295992-W 20140227/140225234521-f52e107a32f080c22e3acde90fcdde53 (fbodaily.com)
 
Source
FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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