Ultra high pressure liquid chromatography with triple quadrapole mass spectrometric detector

REQUEST FOR INFORMATION ONLY Description of Services/Supplies: Ultra high pressure liquid chromatography with a triple quadrapole mass spectrometric detector This is a Request for Information (RFI) to identify the capabilities of the marketplace of all interested parties. This request is for information and planning purposes only and shall not be construed as a solicitation or as an obligation on the part of the Food and Drug Administration (FDA) for any future solicitation. No official solicitation exists; therefore, please do not request a copy of a solicitation. If in the future an official solicitation is released, there is no guarantee that sources responding to this will be included on the source list. Telephone inquiries will not be accepted. The FDA makes no implied or in fact contract by issuing this RFI. Acknowledgement of receipt of responses will not be made, nor will respondents be notified of the FDA's view of the information received. Do not send any material that requires a non-disclosure agreement or that may be business sensitive. Responses received that include a non-disclosure agreement or identify information that is business sensitive will not be accepted. Responses to this notice will not be returned. According to FAR Part 10, Market Research, the results of the market research will be used to: (i) Determine if sources capable of satisfying the agency's requirements exist; (ii) Determine if commercial items or, to the extent commercial items suitable to meet the agency's needs are not available, non-developmental items are available that- (A) Meet the agency's requirements; (B) Could be modified to meet the agency's requirements; or (C) Could meet the agency's requirements if those requirements were modified to a reasonable extent; (iii) Determine the extent to which commercial items or non-developmental items could be incorporated at the component level; (iv) Determine the practices of firms engaged in producing, distributing, and supporting commercial items, such as type of contract, terms for warranties, buyer financing, maintenance and packaging, and marking; (v) Ensure maximum practicable use of recovered materials and promote energy conservation and efficiency; and (vi) Determine whether bundling is necessary and justified. (vii) Assess the availability of electronic and information technology that meets all or part of the applicable accessibility standards issued by the Architectural and Transportation Barriers Compliance Board at 36 CFR Part 1194. The extent of market research will vary, depending on such factors as urgency, estimated dollar value, complexity, and past experience. The contracting officer may use market research conducted within 18 months before the award of any task or delivery order if the information is still current, accurate, and relevant. Market research involves obtaining information specific to the item being acquired and should include- (i) Whether the Government's needs could be met by- (A) Items of a type customarily available in the commercial marketplace; (B) Items of a type customarily available in the commercial marketplace with modifications; or (C) Items used exclusively for governmental purposes; (ii) Customary practices regarding customizing, modifying or tailoring of items to meet customer needs and associated costs; (iii) Customary practices, including warranty, buyer financing, discounts, contract type considering the nature and risk associated with the requirement, etc., under which commercial sales of the products or services are made; (iv) The requirements of any laws and regulations unique to the item being acquired; (v) The availability of items that contain recovered materials and items that are energy efficient; (vi) The distribution and support capabilities of potential suppliers, including alternative arrangements and cost estimates; and (vii) Size and status of potential sources. Mission and Objectives: The evaluation of this instrument will provide DPA with superior abilities for screening of API's, drug products, generic compounds or herbal supplements to identify the presence of designer drugs, impurities, excipients or adulterants (e.g., steroids, amphetamines and erectile dysfunction drugs). This instrument will also enhance the Division's efforts in the study of drug delivery or drug-metabolism-pharmacokinetic (DMPK) for novel drug delivery products (e.g., transdermal drug delivery devices). The requested instrument will improve our analytical capabilities (qualitative and, more importantly, quantitative) for any project requiring high sensitivity, trace analysis in complex matrices such as body fluids (blood, plasma or urine), natural products, etc. The objectives of the FDA in requesting this equipment is part of an overall system that will allow for molecular characterization of protein therapeutics, analysis and discovery of biomarkers, and facilitate PK/PD as well as toxicology studies that are ongoing in DPA and DAPR/CLP. The QQQ mass spectrometers require a stable nitrogen source for spray gas in the ESI source. This spray gas runs continually thus the cost of demurrage for high pressure liquid N2 tanks and their refilling becomes prohibitive. In addition the DPA labs are not equipped for delivery of the large high pressure N2 tanks. Therefore, the QQQ manufacturer recommends the use of an N2 generator with compressor to supply a stable high purity (>99.5%) nitrogen gas source from air for the mass spectrometers as the most cost effective way to supply the instrument with the needed gas. Background The QQQ mass spectrometers require a stable nitrogen source for spray gas in the ESI source. This spray gas runs continually thus the cost of demurrage for high pressure liquid N2 tanks and their refilling becomes prohibitive. Therefore, the QQQ manufacturer recommends the use of an N2 generator with compressor to supply a stable high purity (>99.5%) nitrogen gas source from air for the mass spectrometers as the most cost effective way to supply the instrument with the needed gas. 4. Detailed Technical Requirements I. Performance Specifications Required Features Required Range Max flow rate (L/min ATP) Up to 32 lpm Phthalate Free Nitrogen purity >99.5% Outlet pressure (bar/psi) NLT 6.9/100 Internal air compressors Two compressors Max ambient operating temp 30oC Noise level (db(A)) <58 db (A) II. Trade and Service Specifications 1. 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. The Center for Drugs Evaluation and Research (CDER) must be able to reasonably expect service and technical support from the vendor during its lifecycle. 2. The entire system must be warranted for parts and labor for 12 months from the date of installation. 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. This information shall not obligate CDER to purchase an extended warranty. 3. 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. Deliverables An ultra high pressure liquid chromatography system with a triple quadrapole mass spectrometric detector such as Agilent 1200 HPLC system or equal and an Agilent 6410B triple-quad mass spectrometer with a duty cycle sufficient to accurately quantify chromatographic peaks with peak widths on the order of a few seconds and with the ability to fragment ions in a collision cell for MS / MS characterization or equal. In addition, other items include a gas generator and compressor necessary for the mass spectrometer, an atmospheric pressure chemical ionization (APCI) probe, computer, monitor and software to control, acquire and process data. A service contract for at least 4 years providing "bumper-to-bumper" coverage of all components (both LC and MS) including an annual preventive maintenance and a performance qualification including parts, labor, travel and a performance qualification report. A training course on instrument operation for up to five FDA personnel at the installation site. Unlimited, free technical support by phone or internet. The criteria listed in Table 1 must be satisfied in order to fulfill the Division's requirements as stated above. Table 1: General Requirements Desired Features Desired Range Mass Range 15 - 1650 m/z Maximum LC Flow Rate 2 mL/min Minimum LC Flow Rate 50 - L/min Maximum Duty Cycle Transition Time between ESI + and ESI - Modes 0.5 s Minimum Mass Scan Rate on 1st Quadrapole 5000 amu / s Minimum Collision Dwell Time in Collision Cell 2 ms Minimum MRM's per second 100 MRM's / s Mass Sensitivity (ESI + Mode for Reserpine) s/n defined as 3X RMS noise 1 pg at s/n of 50 Mass Accuracy No less than 0.1 Da across Mass Range Ion Source Design LC Eluent Outlet orthogonal (90) to MS Ion Inlet Ionization Modes ESI+, ESI-, APCI+, APCI- Temperature Controlled Declustering Gas Any Automated Ion Optics Optimization (i.e. a TUNE function) Feature must be included Simple, easy-to-use, integrated automated calibration function requiring little or no calibration standard preparation for daily instrument qualification in a GLP laboratory. Feature must be included Nitrogen Generator / Compressor for mass spectrometer Included* Vendor software / hardware training session for 2 FDA employees at Vendor training center Include Vendor software / hardware familiarization session for up to 5 FDA employees at FDA site Include Free unlimited technical support (phone AND internet) Include Service Contract (2 years) including preventive maintenance and performance qualification Include* RFI Instructions: Please complete Part A, Specification Questionnaire, describing your company's capabilities; Part B, Size of Business and Part C, Estimated Dollar Value Range. Responses shall have the following information: - Identified with the RFI number; - Be no more than ten (10) pages in length; - Not to submit marketing materials; - Submit the response to the email indicated above. FDA makes no implied or in fact contract by issuing this RFI. Acknowledgement of receipt of responses will not be made, nor will respondents be notified of the FDA's view of the information received. Part A. Technical Capability Specification Questionnaire: The offerors should explain why and how their instrument meets or exceeds each detailed technical requirement, and include supportive data and descriptions wherever possible. The detailed responses will be sorted into the following factors: Does your company have the capability to provide the Ultra high pressure liquid chromatography system with triple quadrapole mass spectrometer detector results to the FDA? Does your company have years of expertise in servicing and train the FDA personnel for the above equipment? Does your company meets or exceeds the detailed technical specifications. Emphasis will be placed on the delivery of consistent and controllable N2 gas flow free of contaminants? Does your company provide technical support and service for the instrument over the next 10 years. This factor can be met by demonstrating that the vendor's service department has been adequately staffed in previous years or by customer endorsements or by other methods? Does your company demonstrate that their instrument has been used successfully by the industry to supply N2 gas for mass spectrometry instruments? Does your company have the experience related to the ease of use of the instrument and software. This will include factors related to the ability of the user to export data and images to other programs including Microsoft Office products? Part B. Size of Business State whether your company is a large business, small business (and also state your socioeconomic status), College/University, or a non-profit organization. Part C. Estimated Dollar Value Range Based on the government's mission, objectives, and scope of work, what dollar value range would you determine to be the most accurate rough estimate. 0 Under $150,000.00 0 Over $150,000.00 and Under $500,000.00 0 Over $500,000.00 and Under $1,000,000.00