SOLICITATION NOTICE
66 -- Rheometer and Dynamic Analyzer
- Notice Date
- 8/22/2013
- Notice Type
- Combined Synopsis/Solicitation
- 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
- FDA-SOL-1121872
- Archive Date
- 9/14/2013
- 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
- Combined Synopsis/Solicitation- FDA-SOL-1121872 Subject: Request for Quote Hybrid Rheometer and Dynamic Analyzer This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Subpart 12.6, (STREAMLINED PROCEDURES FOR EVALUATION AND SOLICITATION FOR COMMERCIAL ITEMS) as supplemented with additional information included in this notice. This announcement constitutes the only solicitation. This solicitation is issued as a Request for Quotations (RFQ), using the Simplified Acquisitions Procedures of FAR 13. The solicitation document/incorporated provisions and clauses are those in effect through the current Federal Acquisition Circular: FAC 2005-64. The Government intends to award a Firm Fixed-Price contract. 1.)DESCRIPTION: Hybrid Rheometer with Dynamic Mechanical Analyzer. The Division of Product Quality Research conducts research on assessing the quality and safety of drug products. One of the on-going research activities is to assess the quality of transdermal drug delivery systems. The research involves preparation of transdermal patches on a laboratory scale to study the influence of product and process variables on quality and safety. One of the requirements is to study the rheological properties of transdermal drug delivery systems (TDDS). The rheology of pressure-sensitive adhesives used in TDDS can be studied by means of a rheometer while the rheology of TDDS containing PSA can be studied when a rheometer is attached with a dynamic mechanical analyzer. 2) PRICING CHART: All charges must be included in the quote. Any charges presented after contract award shall be unacceptable. CLIN ITEM QUANTITY PRICE (EA) Total 0001 Dynamic Rheometer 1 0002 Optional Dynamic Analyzer 1 0003 Delivery & Installation 3.) A.) Salient characterizes of the Dynamic Rheometer are as follows: •The rheometer shall incorporate a magnetic levitation thrust bearing, as compared to traditional air or mechanical bearings thereby allowing true accurate instrument torque measurements down to 0.5 nN.m in oscillation measurements and 5 nN.m in steady shear. It must have two radial bearings along the length of the rotating shaft for maximizing radial rigidity. •The torque motor must be a low mass drag-cup induction design with a moment of inertia of no larger than 25 µN.m.s². The moment of inertia reported shall include all moving parts of the motor without a geometry installed. •The rheometer shall be capable of applying up to 200 mN.m or torque and holding this torque continuously in steady shear or creep mode, for a time of 15 minutes, without the need of any external fluid circulating for motor cooling. •The step strain response time of instrument must be no longer than 15 ms to 99% of commanded value and the step rate response time of instrument must be no longer than 5 ms to 99% of commanded value. •The rheometer must include an optical encoder for displacement measurements with a dual encoder reader to obtain an angular displacement resolution down to 2 nrad. It must have an angular velocity range of 0 to 300 rad/s. •The rheometer must have a frequency range of in oscillation mode of 1.E-7 to 100 Hz (7.5E-7 to 628 rad/s). It must include the ability to control and measure normal forces using a force rebalance transducer over a force range of 0.005 to 50 N. •The calibration and Data Validity Features should have an option for a first principle torque calibration with NIST traceability. Torque calibration with certified oil or other material is unacceptable. •The rheometer must display the oscillation waveforms real-time and store the waveform for each data point. The waveform should be viewable in order to provide an indication of the amount of noise, slip, or inertial correction for each point. •The instrument software must report absolute uncorrected torque applied by the motor (not sample torque corrected for moment of inertia) in addition to the stress applied by the motor and the inertia corrected stress actually applied to the sample. •The instrument software must report both raw phase angle and corrected phase angle for oscillation measurements for validation of data quality. Viewing these signals enable full understanding of the effect of moment of inertia on measured data for acceptance. •The rheometer must correct for residual bearing friction. It must allow for motor and geometry inertia correction in both flow and oscillation mode, with the actual inertia measured by the instrument, not with just "book" values of inertia. •The rheometer must be capable of operating in the following test modes: •Oscillation Mode Tests: Torque/Stress sweep (linear or log) at single frequency,Frequency sweep (linear or log) at single torque, Frequency sweep, at single strain, Strain/angular displacement sweep (linear or log) at single frequency, Temperature sweep at single frequency/torque, Superimposed stress oscillation and steady shear, Superimposed strain oscillation and steady shear, Multiple simultaneous frequencies superimposed on above modes. •Flow Mode Tests: Controlled stress or torque sweeps, Controlled rate (1/s) or speed (rad/s) sweeps, Stress stepped flow, Equilibrium stress stepped flow (ensures material has time to respond to each level of stress), Temperature sweeps at constant stress or rate, Squeeze flow and pull off •Creep Mode (transient) Tests: Constant stress creep and recovery, Automatic sensing of steady state during creep test, Stress growth •Stress relaxation (transient) test •The rheometer must be capable of running any of the available tests described above in one mixed procedure. In addition, while running the procedure, succeeding steps can be adapted or new steps added. •The rheometer must have a non-contact temperature control system with the ability to actively measure and control the upper geometry. This solution provides the ability to measure and control both top and bottom plate temperatures independently. This solution provides faster temperature response, true temperature ramps because top and bottom plates heat at the same rate, and elimination of offset calibration tables for upper heater. •The rheometer must offer an Extended Temperature Chamber (ETC) with a range of -160 to 600C and maximum heating rate of 60C/min. This system must be a combined radiant and convection heating system for efficient heat transfer to samples. The system must offer parallel plate, cone and plate, disposable plate (for curing), torsion fixtures (for solids), and SER for extensional viscosity. The ETC temperature chamber must offer an optional camera viewer with remote illumination and focusing to easily see inside the enclosed chamber. The camera must be capable of capturing sample images over the entire temperature range of the ETC. The images must be stored with each data point taken during the experiment and viewable in the analysis software. This will allow the user to access the integrity of the sample during the experiment and provide an additional means of validating data. •The optional Peltier plate system with a temperature range of -40 °C to 200 °C, heating rates up to 20 °C/min, and a temperature accuracy of 0.1 °C. The Peltier plate shall incorporate four Peltier heating elements to cover an 80 mm plate surface directly in contact with an 8 mm thick copper surface with an extremely rugged, hardened chrome surface. This design is required to provide rapid, precise, and uniform temperature control over the entire 80 mm diameter surface allowing testing with geometries 60 mm in diameter without sacrificing horizontal temperature accuracy. The Peltier plate shall be available in a stepped model with interchangeable plate material and surface finishes as well as stepped disposable model for curing samples. The Peltier plate must be capable of controlling from -20°C to 200°C using a single heat sink temperature of 1°C. •An intensive on-site training is to be provided to two of the DPQR scientists to demonstrate the full functionality of the system. B.) Salient characteristics of the Dynamic Mechanical Analyzer are as follows: •The Q800 DMA should incorporate graphite air bearings for "frictionless" movement of the drive shaft over the entire length of travel (25 mm). These should not impart any frictional forces which can provide erroneous and non-repetitive data. •Detection of drive shaft movement on the Q800 DMA should use a linear optical encoder that provides one (1) nanometer resolution over the full 25mm drive shaft travel (Resolution is 1 in 25,000,000). •The Q800 DMA should use a rectangular drive shaft that prevents "torque" to the sample during loading, testing, and unloading. •The Q800 DMA should have a higher maximum force loading (18 newtons) allowing for a wider array of materials to be studied, including the stiff samples analyzed in our laboratory. •The Q800 DMA should incorporate an automated movement furnace with an overall temperature range of -150 to 600C, and heating rate control of 0.1 to 20C/min in 0.1C/min increments. •The Q800 DMA should incorporate automated clamp calibrations that are specific for each clamp type, and can be performed when switching clamps. Clamp compliance must be calibrated for each clamp type during this calibration. •It should have a humidity accessory allowing mechanical properties of a sample to be analyzed under controlled conditions of both relative humidity (5-95% RH) and temperature (5-120°C) and can operate in isothermal or temperature ramping mode (<±1°C/min), and in isohume or humidity ramping mode (±2% RH/min). •The Q800 should be an extremely versatile instrument as well, capable of performing the following range of experiments: a.)Force-track/auto tension modes. b.)Preview Measurement. c.)Temperature Ramp/Single Frequency. d.)Temperature Ramp/Frequency Sweep. e.)Temperature Step & Hold/Frequency Sweep. f.)Constant Temperature, Stress/Strain Sweep. g.)Constant Strain Rate. h.)Isotrain. i.)Creep. j.)Stress Relaxation. 4) Packing, Marking, Delivery and Shipping: Delivery and bench top installation will be made no later than 90 days following the date of award. Installation includes necessary set up and assembling of all accessories. Delivery shall be made to: The US Food and Drug Administration White Oak Campus Room 1066, WO Building 64 10903 New Hampshire Ave WO Building 62 Loading Dock Silver Spring, MD 20993 Assembly will be completed at: Building 64, Room 1083. 5) RFQ Instructions: The vendor must complete the Pricing Chart provided in this RFQ. Responses shall have the following information: - Identified with the RFQ number. - The vendor must complete the Pricing Chart above. - Responses shall be submitted to the Contract Specialist's email below, please include FDA-SOL-1121872 in the subject line. -All questions shall be submitted to the Contract Specialist's email, below. - Quotes must be for all the items requested or none. - Quotes must remain valid for 90 days. - Response Due Date shall be no later than: August, 30th at 12:00 pm EST. EVALUATION AWARD CRITERIA The Government shall award this contract to the Lowest Price Technically Acceptable (LPTA) Quote. GENERAL INFORMATION CONTRACTING POINT OF CONTACT: Christopher R. McGucken 5630 Fishers Lane, Room Rockville MD 20857 Voice: 301.827.7161 Email: Christopher.McGucken@fda.hhs.gov
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- Record
- SN03158733-W 20130824/130822235810-6550ea1159e13b174c30e991e8c6b8ed (fbodaily.com)
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