SOURCES SOUGHT
66 -- Thermogravimetric Analyzer and Differential Scanning Calorimeter
- Notice Date
- 7/15/2013
- 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, 3900 NCTR Road, HFT-320, Bldg 50 | Rm 421, Jefferson, Arkansas, 72079, United States
- ZIP Code
- 72079
- Solicitation Number
- FDA1119919
- Archive Date
- 8/15/2013
- Point of Contact
- Nicholas E Sartain, Phone: 870-543-7370
- E-Mail Address
-
nick.sartain@fda.hhs.gov
(nick.sartain@fda.hhs.gov)
- Small Business Set-Aside
- N/A
- Description
- MARKET RESEARCH PURPOSES ONLY NOT A REQUEST FOR PROPOSAL OR SOLICITATION The U.S. Food and Drug Administration (FDA), is conducting market research to support the Office of Regulatory Affairs (ORA) requirement for a Thermogravimetric Analyzer and Differential Scanning Calorimeter. The FDA is seeking small businesses sources to determine the availability and capability of small business manufacturers or small businesses capable of supplying, and subsequently maintaining, a U.S. made product of a small business manufacturer or producer for the instruments described herein. Other than small business concerns are also encouraged to submit capability statements. The following information is provided to assist the FDA in conducting Market Research to identify potential contractors for this effort: The associated North American Industry Classification System (NAICS) Code is-334516- Analytical Laboratory Instrument Manufacturing; Small Business Size Standard is 500 employees. The U.S. Food and Drug Administration (FDA), Office of Regulatory Affairs (ORA), Arkansas Regional Laboratory (ARL) requires one (1) Thermogravimetric Analyzer (TGA) and Differential Scanning Calorimeter (DSC). Performance requirements for Thermogravimetric Analyzer: The FDA/ORA/ARL is required to perform complete chemical characterization of the composition of nanomaterials, including the determination of the nanomaterial's purity and the quantification and identification of any ligand (e.g. drug, antibody, polymeric coating) bound to the nanomaterial. This can be best accomplished with the acquisition of a thermogravimetric analyzer (TGA) that would accurately determine small weight changes, reliably process small sample sizes, and be easily interfaced to a Fourier transform infrared spectrometer (FTIR), a mass spectrometer (MS) and/or a gas chromatography-mass spectrometer (GC-MS) system for evolved gas analysis. System specifications • Operates on US standard 120V electric service. • Shall be composed of a high sensitivity balance and a quick response furnace. • Capable of accurately and reliably measuring a 1% weight loss (e.g. polymer coating) from a 1 mg nanomaterial sample. • Capable of performing evolved gas analysis; shall be easily coupled to an FTIR, MS and/or GC-MS system. The evolved gases from the TGA instrument shall remain uncontaminated and undiluted for introduction into an MS and/or FTIR system. • Capable of reliably accommodating and analyzing sample sizes < 1.0 mg to at least 500 mg. • Capable of automatically reading and recording initial sample weight. • Shall possess a gas-delivery system, for at least two gases, that minimizes leaks and ensures repeatable analysis conditions. As an option, the contractor shall provide information on the availability and cost of delivery systems for additional gases. • Capable of performing automatic gas switching and mixing during measurements. • Capable of running in oxidizing and inert atmospheres. • Shall possess temperature accuracy and precision of at least ± 1°C. • Capable of operating at temperatures from ambient to at least 1000°C. • Capable of cooling down from 1000°C to < 100°C in under 15 minutes. • Capable of linear heating rates from 0.1 °C/min to at least 100 °C/min. • Weighing precision (defined as the standard deviation of at least 10 measurements of a 100mg standard weight, with removing and replacing the sample in between each measurement): ¬ equal to or better than ¬+0.01% • Weighing accuracy: equal to or better than +0.1% • Sensitivity (Defined as 3X the average rms noise over the temperature range 50 to 1,000°C): equal to or better than 0.1 µg • Baseline linearity over the temperature range from 50 to 1,000°C (defined as the average absolute deviation from a best fit linear regression of a baseline can without any smoothing or blank subtraction applied): equal to or better than 20 µg • Baseline drift over the temperature range 50 to 1,000°C without any blank subtraction (defined as the maximum deviation from the smallest measured weight to the largest measured weight of an empty platinum pan, while being heated at 20°C): equal to or better than 10 µg • Signal resolution (defined as the smallest measurable difference between two adjacent values): equal to or better than 0.1 µg • The contractor shall provide detailed information on the minimum sample weight required to reliably detect a 1% weight loss. Software • Capable of instrument control and data analysis. Data analysis software shall allow for installation on at least two computers. • Shall perform all functions without the requirement of internet access. • Shall include automated calibration routines for weight and temperature calibrations. • Capable of performing automatic baseline correction. • Contractor shall include coverage for software and firmware updates that can be installed without internet access. • Shall include automatic buoyancy corrections for temperature and gas flow rate. Accessories The system shall include the following accessories: • A computer-controlled autosampler with automated pan punching, or equivalent, for at least 20 samples. The autosampler shall run, analyze, and plot samples unattended and without disturbing the balance. It shall also be capable of directly punching sealed pans in a contamination-free manner. • User's manual. • Appropriate tubing/regulators/power cords/miscellaneous fittings and parts (e.g. cabinet, DSL router) required for turnkey operation. • An accessory kit that includes pans/crucibles, temperature and weight calibration standards, and appropriate tools. Performance requirements for Differential Scanning Calorimeter:... To achieve the goals of its Nanotechnology Program, the FDA/ORA/ARL is required to perform complete characterization of the physicochemical properties of nano-based regulated products (e.g. drugs, dietary supplements and foodstuffs) and nano-based test articles to be used in toxicity studies. The acquisition of a differential scanning calorimeter (DSC) will allow the Government to accurately determine the thermal properties of these materials, including glass transitions, melting temperature, and crystallization temperature, among others. This information is important for the evaluation of the material's purity and stability. For example, for the characterization of liposomal dietary supplements and liposomal drugs, DSC will serve as a powerful tool for quality control, because the thermal phase transitions of the liposomes are sensitive to both the chemical composition of the liposomes and their physical state (i.e. size). DSC will thus provide the Nanotechnology Core Facility at ARL with a direct approach to assess the purity, quality and stability of a liposomal formulation. Furthermore, it will allow for the straightforward determination of the stability of the biological component of therapeutic drugs that consist of a protein conjugated to a nanomaterial. System and software specifications Sample compartment of differential scanning calorimeter must be thermally isolated from rest of the instrument and electronics, and power supply must be in separate compartments. System must be able to auto calibrate with software control. System must consist of auto sampler, which can load and unload full range of sample volumes in multiple types of sample holders and reference samples. Auto sampler must be able to handle at least 30 samples. System must have operation range from -150 C to 700C with appropriate cooling system and air flow system. The system should be a bench top design. The system must have following minimum requirements; a) Temperature accuracy value must be equal or lower than (+/-)0.1 K b) Temperature precision value must be equal or lower than (+/-)0.01k c) Calorimetric dynamic range must be (+/-)500 mW or grater d) Calorimetric accuracy must be smaller than (+/-)3% e) Calorimetric precision value must be smaller than (+/-)0.1% f) Enthalpy precision value must be <(+/-)0.1% g) Heat flow noise (root mean square) must be smaller than 0.1% h) Baseline linearity (at temperature range of -50-400 0C) must be smaller than 10 µW i) Baseline accuracy (at temperature range of -50-400 0C) must be smaller than ±40 µW j) Baseline repeatability (at temperature range of -50-400 0C) must be smaller than ±10 µW k) Indium response ratio must be greater than 50 Software must have the following: A) Real-time instrument tuning B) Windows based operating system C) Automatic calibration D) Operation of auto sampler E) Real time display of signals, which includes, but not limited to, Total Heat Flow, Total Heat capacity, reversing heat capacity, reversing heat flow, non-reversing heat flow, modulated heat flow, temperature amplitude and heat flow amplitude. F) Data analysis must abele to calculate heat capacity and generate thermodynamic parameters of samples at minimum sample volume. G) Graphs and data must be stored and export in other useable forms such as images. H) Software must be able to use for offline data analysis Contractor shall demonstrate upon installation that the item meets all performance specifications, including the differential calorimeter sensitivity specification, baseline accuracy, baseline repeatability, minimum sample volume, enthalpy repeatability, enthalpy precision and indium response ratio. The instrument shall not be accepted until those performance specifications have been met TGA and DSC Requirements. General specifications • The components must be newly manufactured units, not used and refurbished or previously used for demonstration. • The system shall be delivered with all necessary supplies and accessories required for installation and start-up. • Installation and on-site training covering the operation, calibration, and routine maintenance of the system components, sample preparation for analysis, and use of the software to operate the system and perform data analysis shall be provided by the contractor. • The contractor should provide information on the availability and cost of theory/applications training at the contractor's training facility. Such training would provide detailed information on the entire system, include both hardware and software. • The contractor shall demonstrate, upon installation, that the system meets all performance specifications. The instrument shall not be accepted until those performance specifications have been met. • The contractor shall include a complete computer-based workstation for instrument control, data acquisition, and data analysis, including the monitor. Shall be a turn-key solution i.e. the contractor shall be responsible for providing all hardware, components, instruments, computers, software, start-up and that otherwise required to meet these specifications and the FDA's stated need. Instrument shall be warranted for not less than one (1) year to commence upon formal acceptance of the system by the FDA. Post-Warranty Service Agreement (preventive and corrective maintenance) for up to four (4) 1-year option period. Respondents shall provide differing levels of service agreement plans available. FOB Point Destination. All items shall include delivery to the destination identified below. Desired delivery date is within 90 calendar days after receipt of order. FOB Point of Delivery for Services and Supplies will be the FDA located at 3900 NCTR Road, Building 26, Room B360, Jefferson, AR 72079 The offeror shall furnish sufficient technical information necessary for the Government to conclusively determine that the offered products/services and components meet the technical requirements identified above. Though the target audience is small business manufacturers or small businesses capable of supplying a U.S. made product of a small business manufacturer or producer all interested parties may respond. At a minimum, responses shall include the following: • Business name, DUNS number, business address, business website, business size status (i.e., SB, VOSB, SDVOSB, HUBZone SB, SDB, WOSB, LB), point of contact name, mailing address (if different from business address), phone number and email address (Provide this same information if responding to provide a product manufactured by another firm); • Sufficient descriptive literature that unequivocally demonstrates that offered products and services can meet the above requirements. All descriptive material necessary for the government to determine whether the service/product offered meets the technical requirements including: technical specifications, descriptive material, literature, brochures and other information, which demonstrates the capabilities of the contractor to meet the requirement. • The contractor shall provide detailed information on the minimum sample weight required to reliably detect a 1% weight loss. • Information on available service/maintenance plans. • Three (3) years of past performance information for the manufacture and/or sale and maintenance support of same or substantially similar items to include date of sale, description, dollar value, client name, client address, client point of contact name, client point of contact mailing address (if different from that provided for client), client point of contact phone number, client point of contact email address, and name of the manufacturer (to include DUNS number and size status) if not the respondent. • If applicable, identification of the firm's GSA Schedule contract(s) by Schedule number and SINs that are applicable to this potential requirement. • Provide information if any of these specifications are too restrictive or more information on balances are needed. No response will be considered that the listed specifications are adequate in a competitive environment. • If a large business, identify the subcontracting opportunities that would exist for small business concerns; and • Though this is not a request for quote, informational pricing is encouraged. The government is not responsible for locating or securing any information, not identified in the response. The Government encourages any comments and/or suggestions from any interested party, regarding the specifications. While the Government will not respond directly to your comments and/or suggestions; we will consider them as we finalize the specifications in preparation for the forthcoming solicitation. Interested Parties must respond with capability statements which are due in person, by postal mail or email to the point of contact listed below on or before July 31, 2013 by 13:00 hours (Central Time in Jefferson, Arkansas) at the Food and Drug Administration, OO/OFBA/OAGS/DAP, Attn: Nick Sartain, 3900 NCTR Road, HFT-320, Jefferson, AR 72079-9502 or email nick.sartain@fda.hhs.gov. Reference FDA1119919. Notice of Intent Responses to this sources sought announcement will assist the Government in determining whether or not any future requirement similar to this one should be set aside for small business, made available to full and open competition or procure through sole-source acquisition procedures. 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 perform the work. 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 pre-solicitation synopsis and solicitation may be published in FedBizOpps. 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).
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/NCTR/FDA1119919/listing.html)
- Place of Performance
- Address: 3900 NCTR Road, Jefferson, Arkansas, 72079, United States
- Zip Code: 72079
- Zip Code: 72079
- Record
- SN03116620-W 20130717/130715234926-ee12c4533106c2f7b4a1ecffe092b0fd (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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