SOURCES SOUGHT
66 -- FTIR Microscope as Add-On to Existing Nicolet iS 10 FTIR
- Notice Date
- 6/2/2015
- 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-SS-15-1146673
- Archive Date
- 6/23/2015
- Point of Contact
- ZetherineGore, Phone: (301) 827-5093
- E-Mail Address
-
zetherine.gore@fda.hhs.gov
(zetherine.gore@fda.hhs.gov)
- Small Business Set-Aside
- N/A
- Description
- This is a Sources Sought Notice posted for informational purposes only. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding the availability and capability of all qualified sources to provide the identified equipment. This is strictly market research to assist in determining the appropriate acquisition strategy and available resources to obtain equipment that meet the required specifications as described in this notice. Responses to this sources sought notice shall be the submission of information that clearly demonstrates a vendor's capability to provide the equipment which meets the specifications. The Food and Drug Administration will not entertain questions regarding the results of the market research. General Information An FDA laboratory frequently receives herbal samples to analyze for adulteration with drugs, without receiving any guidance which identifies the drugs of concern. Foreign matter crystals can be selected and the chemical identification performed with a Fourier Transform Infrared (FTIR) microscope. Using this technique, FDA can better isolate and identify chemical substances. This cannot be done very easily using chemical techniques. The use of an FTIR microscope will help FDA to identify what a sample is adulterated with so that a quantitative confirmation can be performed. This requirement is for an add- on microscope that is compatible with an existing iS 10 FTIR optics bench. Specifications/Salient Characteristics Functional Specifications for FTIR Microscope as an Add-On to Existing Nicolet iS 10 FTIR The FTIR Microscope as Add-On shall meet the following requirements: Microscope Module The microscope module shall meet the following specifications: 1. The add-on microscope and all software must be compatible with and completely interfaceable to an existing Nicolet iS10 FTIR optics bench. 2. The FTIR microscope shall allow for simultaneous transmission viewing of the sample while collecting an IR spectrum of that sample. This is very important feature for doing surveys of a sample while seeing changes to the IR spectrum simultaneously. This capability will save time in performing sample analysis and give pin-point accuracy. 3. The FTIR microscope shall have optics that allows the user to have complete visualization of the entire field of view, including the sample spot, when the aperture is set to the appropriate size and rotation. This capability shall be available via the video display in the software as well as through the eyepieces of the microscope. The view shall not be obscured by overlaid glass aperture lines or any other visual artifacts. This feature presents a huge time savings while setting up analyses. 4. The FTIR microscope shall offer dual-remote aperturing. This means that there is an aperture pre-sample and an aperture post-sample in both the reflection and transmission sampling modes. This is critical to FTIR microscopy applications because dual aperturing helps eliminate stray light caused by diffraction of nearby particles outside of the area of interest. This keeps unwanted spectral information out of sample analysis. 5. The FTIR microscope shall be an infinity corrected microscope. This means that other than the objective and condenser, there are no focusing mirrors or optics in the entire system until the infrared (IR) beam is focused onto the detector. This results in the highest quality visual image of the sample and allows for multiple optional visual optical enhancements to the system. It shall include the addition of Nomarski DIC Optics, Fluorescence Illumination, and IR and visible polarizers which are important to our analysis to aid in the visualization of contamination and artifacts that may be otherwise unseen by visible light. 6. The system shall also include a 4-place rotatable nosepiece with a 10X glass objective and a 15X Infinity corrected reflachromat objective. Each of the IR objectives shall have continuous compensation capabilities to allow for adjustment of the focal length of the lenses. Instruments that do not account for this continuous compensation will generate much poorer image quality. 7. The microscope shall utilize a slide on ATR crystal for doing micro-ATR analysis. This is an important capability for analyzing very small particles or thick samples that would otherwise not be possible through other techniques. The ATR can be slid in and out of position as needed, allowing for quick survey and ATR collection of the area of interest in seconds. The slide on ATR can be easily removed for thorough cleaning of the ATR crystal to ensure no cross contamination of samples occurs. 8. The system shall include a data station/computer that meets the following criterion: a) The system shall include a compatible computer system that can interface with the above system. b) The software shall be 21 CFR Part 11 compliant. c) The software shall operate both the FTIR and the microscope. d) The software shall not allow the over writing of files in any situation, even with permission. The components and/or equipment shall be a newly manufactured, not used and refurbished, or previously used for demonstration. The vendor must also be capable of providing initial qualification, operational qualification, and performance qualification (IQ/OQ/PQ) validation training services for all provided components. Anticipated Delivery Period. Delivery is required within 30 days after the purchase order award. Capability Statements. Respondents are asked to submit a capability statement which provides a description of the equipment (including the specifications), that they can provide to satisfy all of the FTIR Microscope as Add-On to Existing Nicolet iS 10 FTIR Specifications/Salient Characteristics listed in this notice. Respondents are requested to provide the following business information: DUNS Number, Company Name, Company Address, Company Point of Contact (name, telephone, and email address), and Type of Business (e.g., large, small, 8(a), woman owned, veteran, HUBZone, etc.) pursuant to the applicable NAICS Code 334516 - Analytical Laboratory Instrument Manufacturing, Small Busies Size Standard - 500 employees. Response Format. Capability statements should be provided in Adobe PDF with page size 8.5 x 11 inches. Font shall be Times New Roman Size 12 with no less than single spacing between lines. Due Date. Capability statements must be received by 1:00 p.m. (Eastern Standard Time) on Monday, June 8, 2015. Submission. Capability statements must be provided electronically via email to Zetherine Gore, Contract Specialist at zetherine.gore@fda.hhs.gov. Disclaimer and Important Notes. 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 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 provide a FTIR Microscope as an Add-On to Existing Nicolet iS 10. 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 combined solicitation/synopsis may be published in Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation. Confidentiality. 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 any resultant solicitation(s).
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- Record
- SN03749894-W 20150604/150602234830-de338a4be84211c5f2dec9fbc32b622a (fbodaily.com)
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