SOURCES SOUGHT
66 -- High Pressure (HPLC/UHPLC) System
- Notice Date
- 3/18/2014
- 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-14-1130732-SS
- Archive Date
- 4/5/2014
- Point of Contact
- Tania Gates, Phone: 301-827-7176
- E-Mail Address
-
tania.gates@fda.hhs.gov
(tania.gates@fda.hhs.gov)
- Small Business Set-Aside
- N/A
- Description
- Notice to Small Businesses The purpose of this notice is to obtain information regarding the availability and capability of qualified small business concerns; 8(a), Woman-Owned Small Businesses (WOSB), Historically Underutilized Business Zone (HUBZone), Small Businesses, and Service-Disabled Veteran-owned Small Businesses (SDVOSB). The Food and Drug Administration intends to provide maximum practicable opportunities in its acquisitions to small businesses. Background The Food and Drug Administration (FDA) is conducting a market survey to assess the availability of small business firms as defined by NAICS code 334516 to provide a High Pressure (HPLC/UHPLC) System with Diode Array Detector, Mass Detector and Nitrogen Generator. This notification is for market research purposes and does not constitute a commitment, implied or otherwise, that a procurement will be accomplished. FDA welcomes responses from all interested parties. FDA does not intend to make a selection decision or award a contract on the basis of responses nor otherwise pay for the preparation of any information submitted or FDA's use of such information. Acknowledgment of receipt of responses will not be made, nor will respondents be notified of the outcome of the FDA's review of the information received. Additionally, the FDA does not intend to hold discussions concerning this sources sought with any interested parties. However, FDA reserves the right to contact vendors if additional information is required. Requirement The potential requirement is to procure a High Pressure (HPLC/UHPLC) System with Diode Array Detector, Mass Detector and Nitrogen Generator that adheres to the following minimum salient characteristics: HPLC/UHPLC System • Controller computer with printer Intel 3.0 GHz processor or equivalent with minimum 4 GB RAM, minimum 250 GB hard drive, 4 USB ports, at least one 10/1000 Ethernet port, 64 bit Operating system, monitor CD ROM drive, 12A @ 100-127 VAC power requirement, Network capable Laserjet printer or equivalent. • Maximum operating pressure 15,000 psi up to 1 mL/min, 9000 psi up to 2 mL/min • Dwell volume (total system) <400 Microliters with 100 microliter mixer • Cycle time <30 seconds inject-to-inject • Needle height control Programmable in 0.1mm increments • Sample Manager Capabilities Auto-dilution and auto-addition. Must be a programmable, automatic liquid sampler for use in HPLC/UHPLC. Precision equal to or better than 0.5% RSD from 0.2 to 1.9 uL and equal to or better than 1.0% RSD from 2.0 to 10 uL range. • Number of sample plates Any two of the following: - 96 and 384 microtiter plates - 4 position 2.00 mL vial plates - 48 position 065 mL micro-centrifuge tube plates - 24 position 150 mL micro-centrifuge tube plates • Injection volume range 0.1 - 10.0 microliter as standard. Up to 1000.0 microliter with extension loops • Quaternary Pump The pump must be a quaternary pump designed for Ultra Performance Liquid Chromatography, designed to blend up to four solvents simultaneously in any proportion or concentration • Integrated degasser Operates up to the maximum flow rate, with an independent channel for each solvent. The degasser needs to support up to 2 additional channels for the sample manager • Pump flow Settable from 10-2000 µLs/minute, settable in 1.0 µLs/minute • Pump contribution to delay volume <375 µL with 100 µL mixer configured • Compositional Ripple (or baseline noise) <1.0 mAU with 100 µL mixer configured, (default configuration). Less than <0.1 mAU can be achieved with optional 250 µL mixer installed. • Support flow ramping Settable from 0.01 to 30.00 minutes to reach 2.0 mL/min, the maximum flow rate and automatically synchronize injection start between the pump and the sample manager to enhance retention time reproducibility. The pump must have automatic and continuous compressibility compensation, requiring no user intervention. • Flow accuracy ±1.0% at 0.5 to 2.0 mL/min using 100% A Back pressure 600 to 1000 psi with degassed H2O • Flow Precision 0.075% RSD or ±0.020 min SD, whichever is greater, based on six replicates 60:40 H2O/MeOH 0.5 mL/min, alkylphenone mix (5.0 microL injection volume) • Operating flow rate range 0.010 to 2.000 mL/min, in 0.001 mL increments • Gradient profiles 11 gradient curves (including linear, step (2), Concave (4) and Convex (4)) • Pump seal wash Equipped with a wash system to flush the rear of the high pressure seal and plunger • Column Compartment Temperature range 4.0-90.0ºC settable in 0.1ºC increments. Two independent heat/cool zones per module up to six zones in stacked configuration. Must be designed for UPLC/UHPLC, designed to operate up to 15000 psi. The column heater contribution to delay volume shall be typically <2 µL with active pre-heating. The column compartment shall support optional column switching, with integral column bypass and waste channels, without any plumbing changes. When a column is switched the system shall decompress to protect column lifetimes. The column compartment must actively preheat the mobile phase solvent, enhances method transfer between column compartments. The column compartment shall support option passive pre-heating. • Temperature accuracy ±0.5ºC • Temperature stability ±1.0ºC • Column Capacity CH-A: Single column up to 4.6 mm internal diameter (ID) up to 150mm in length with filter or guard column CH-30A: Single column up to 4.6 mm internal diameter (ID) up to 300mm length with filter or guard column • Column Tracking Column information management tracks and archive column usage history. The system shall support technology which documents the methods and usage of columns, up to 50 sample sets, the minimum and maximum pressure and temperature, sample and injection totals for the column can be stored and accessed using system Console software. • Column Manager The column manager compartment must allow for stacking to enable support up to 2 or more columns, with pre-filters or guard columns, from 1.0 mm to 4.6 mm ID and up to 150 mm length. • Sample compartment temperature range 4.0 - 40.0ºC Settable in 0.1ºC increments with tolerance range between -2 and +4ºC • Chromatographic Software Fully utilizes an integrated, relational database for data retrieval and processing. Secure environment for the storage of information data system which will provide a fully optimized implementation of client/server technology for both hardware and software. User accounts, user privileges and audit trails are maintained by database and not by the operating system. All meta-data (raw data, methods, results, and calibration curves) are automatically managed, linked and versioned. Shall include all necessary licenses to fully analyze and create reports from data. Installation with IQ, OQ and PQ with system suitability should be included. DAD/Photodiode array • Optical Resolution 1.2 nm • Flow cell design Light guiding UPLC intelligent technology • Path Length 10 nL (analytical cell) • Cell Volume 500 nL (analytical cell) • Data acquisition Up to 80 Hz • Pressure limit 1000 psi • Wavelength range 190-500 nm upgradable to 800 nm Mass Detector • Integration with software Must be able to connect to system and work directly with HPLC/UPLC system software • Atmospheric Pressure Ionization (API) source and ionization modes Ion polarity switching Integrated adjustment free plug and play probe De-clustering cone gas Tool free access to customer serviceable elements Automated control of gas flows and heating elements • Mass analyzer Automated mass calibration and resolution verification for quadropole and analyzer and pre-filter • Detector Long axis long life photomultiplier detector. Digital dynamic range up to 4e6 • Power supply 110-240 V ac 50/60 Hz • Acquisition modes Full scan and Selected Ion Recording • Mass Range 30-1250 m/z • Data acquisition Automatically optimizes for quality of acquisition rates • Mass accuracy <±0.2 Da over full range • Linear response Relative to sample concentration with up to 4 orders of magnitude from limit to detection • Mass resolution 0.7 Da Nitrogen Generator • LC/MS grade Nitrogen (L/min) 32 • Inlet Air Requirement (L/min) 90 • Min/Max Air Inlet Pressure 125-145 psi • Min/Max Operating Temperature 5º C (41º F) - 30º C (86º F) • Particles <0.01 µm • Pressure Dewpoint -40º C/40º F • Electrical Requirements 230v 50/60Hz 7.0A Delivery Location Food and Drug Administration 300 River PL Ste 5900 Detroit, MI 48207-5057 General Instructions Contractors that believe they possess the ability to provide the required equipment must submit documentation of their ability to meet each of the project requirements to the Contracting Officer. The capability statement should include the organization name, type of business, DUNS number, point of contact name/telephone number/email address, and applicable NAICS code. Capability statements that do not provide sufficient information for assessment will be considered non-responsive. When submitting the information, please reference the solicitation number FDA-14-1130732-SS. Responses should be submitted via email to Tania Gates at Tania.Gates@fda.hhs.gov by 12:00 noon on March 21, 2014.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/FDA-14-1130732-SS/listing.html)
- Record
- SN03313082-W 20140320/140318234458-f6cc539333cc71d299f89ec1e35cf235 (fbodaily.com)
- Source
-
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