FTIR Chemical Imaging Microscope System

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 The Denver laboratory frequently receives herbal samples for adulteration with drugs without guidance as to the presence of what drugs they are concerned about. With a FTIR microscope, foreign matter crystals can be selected and the chemical identification performed. Using this technique, FDA can better isolate and identify chemical substances. This will increase the ability to determine what chemical substance a sample is adulterated with, so that a quantitative confirmation can be performed. Specifications/Salient Characteristics Functional Specifications for FTIR Chemical Imaging Microscope System The total system shall meet the following requirements. Microscope Speciifications The FTIR chemical imaging microscope module shall include and meet the following specifications: 1. High precision motorized stage with quick-release Locking system 2. Joy stick for controlling the motorized stage 3. Ultra-Fast Mapping Technology 4. Motorized triple-detector system 5. Room Temperature Detector 6. LN2 Cooled MCTA Detector 7. LN2 Cooled MCTA linear array detector 8. Gold coated infrared imaging optics with vignetting control for optimized array illumination 9. Motorized zoom optics for 6.25, 25 and 50 microns pixel resolution with array detector 10. Stainless steel LN2 dewar design, 16 hours hold-time minimum 11. Anti-fog coating and long-life vacuum seals provide years of hassle-free operation 12. Motorized, software controlled polarizer 13. Motorized, software controlled analyzer 14. Polarizer rotation control 15. Micro-compression cell with diamond windows 16. Slide on ATR crystal for performing 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 shall slide 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 shall be easily removed for thorough cleaning of the ATR crystal to ensure no cross contamination of samples occurs. The Slide on ATR shall consist of: - Multi-coated, conical shape germanium tip crystal - 350 micron spherical finish allows gentle contact with sample and small footprint - High precision easy alignment slide mount - Minimum throughput at default aperture size equal or better than 50% of reflectance - Heavy-duty crystal locking allows ATR-survey mode, while in contact with samples - High depth of penetration, ideal shape for residuals inside depressions - With imaging detector optics and zoom, provides better than 2 micron spatial resolution 17. Imaging ATR Accessory for Microscopy and shall include: - Large-area germanium ATR crystal - Integrated pressure device - Sample mounting spacer kit - Sample transfer tool 18. FTIR microscope polystyrene standards plate that includes the following: - Serialized and certified validation plate for manual or semi-automated operation - NIST polystyrene for Transmission - NIST polystyrene for Reflection - NIST polystyrene for ATR - Gold reference disk for reflection background reference NIST traceability certificate and protective case 19. FTIR module with the following specifications: - MCT Detector with CdTe window - Smart OMNI Transmission Accessory - Sealed and Desiccated with BaF2 coated, KBr windows - Metal case desiccant canister (re-generable), humidity indicator - Multi-zone purge system - 0.4 cm-1 resolution - Motorized validation wheel with serialized standards for SPV 20. Data Station/Computer that includes and meets the following criterion: - Compatible to interface with the FTIR Chemical Imaging Microscope System including monitor, printer and computer - Comprehensive spectral library - Software shall be 21 CFR part 11 compliant - Software shall operate both the FTIR and the chemical imaging microscope - Software shall not allow the over writing of files in any situation, even with permission - Validation software modules 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 satisfy all of the FTIR Chemical Imaging Microscope System's 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 the FTIR Chemical Imaging System. 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).