SOURCES SOUGHT
65 -- Gas Chromatograph
- Notice Date
- 6/11/2010
- Notice Type
- Sources Sought
- NAICS
- 334516
— Analytical Laboratory Instrument Manufacturing
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, Clinical Center/Office of Purchasing & Contracts, 6707 Democracy Blvd, Suite 106, MSC 5480, Bethesda, Maryland, 20892-5480
- ZIP Code
- 20892-5480
- Solicitation Number
- P176385
- Archive Date
- 7/10/2010
- Point of Contact
- Brian J. Lind, Phone: 301-402-0735
- E-Mail Address
-
LindBJ@cc.nih.gov
(LindBJ@cc.nih.gov)
- Small Business Set-Aside
- N/A
- Description
- Sources Sought/Market Survey Notification The National Institutes of Health (NIH) Clinical Center Pharmacy Department is conducting a market survey to determine the availability and technical capability of qualified small businesses, including (8A) small businesses or HUBZone small businesses capable of providing the following services; The NIH Pharmacy, Pharmaceutical Development Services (PDS), is engaged in building a new facility in compliance with FDA current Good Manufacturing Practices (cGMP) and in order to comply with requirement a Gas Chromatograph (GC) instrument is needed to analyze drug substances and drug products per specified GC methods described in USP monographs and meet FDA guidelines. This GC must meet the standards outlined in United States Pharmacopeia (USP) chapters 467 and 621 and monographs that specify assay by GC and the Food and Drug Administration (FDA)/ Current Good Manufacturing Practices (cGMP) requirements as described in Code of Federal Regulations chapter 62, pp 67380 to 67381. The NIH/PDS is seeking a contractor to provide a GC Instrument meeting the following specifications: Technical Specifications Detectors: • The GC detectors must be designed to accommodate capillary columns and Flame Ionization Detector (FID). • The GC must have the versatility of easily adding other detectors such as Thermal Conductivity Detector (TCD) as a plug in. • The system must be equipped with a detector control system optimized for dual detectors (FID and TCD) and comes standard with auto-ignition and re-light features. • All detectors must be easily accessible from the top cover of the instrument for quick maintenance. • The system must have a sampling rate of up to 250HZ narrow peaks for fast GC applications. • Flame Ionization Detector(FID) should have capillary and packed columns • FID to have a temperature range up to 450C maximum • FID to have minimum detected quantity to be at least 1.5pgC/s(dodecane) Advanced Flow Control: • The GC must be capable of delivering column flow during temperature programming in Constant Linear Velocity Mode. The flow module must be capable of 1200 ml/minute total flow, 980Kpa head pressure and achieving split ratios of 9999.9:1. Column Oven: • The GC oven capacity must be equal to or less than 15.8 L for greater performance in heating and cooling capabilities. • Temperature range of the unit must meet or exceed ambient + 10°C up to ~ 400°C; and by adding the liquid CO2 cryogenic accessory the range can extend from -50°C - 400°C). • The system must be able to set up to 20 different temperature ramps and 7 different pressure ranges during a run for added research optimization. The GC must cool from 450C to 50C in < 4 minutes) Large LCD Window: • The GC must have an easily readable LCD window that shows graphically all of the operation of the GC, including the data results, temperature profile, and the full chromatographic display in progress without having to change to another screen. Intelligent Self-Diagnostics: • The GC must provide a complete self-diagnostics functionality and complete logging functions, which are compliant with GMP requirements. Digital Control: • The GC must have the ability for the user to digitally set the column inlet pressure, column flow rate, linear velocity, and split ratio without the use of any external flow meters. Injection Systems: • It should have GC Static Headspace and Liquid Injection Systems. • The system is able to combine liquid, large volume, head space and Solid Phase Micro Extraction (SPME). This way one should be able to switch quickly from one application to another using the same GC workstation. • The user must have the capability of choosing from among a split/splitless, on-column, large volume temperature programmable (PTV) or direct injection unit. • Sample Injection unit to have temperature range up to 450C, heating settings to be 1C steps. • Sample injection unit should have up to 3 units installed simultaneously. Carrier Gas Flow Controller: • Flow rate setting range to be 0 to 100 ml/min for packed. • Must maintain set flow rate during column oven heating. • Pressure setting range to be 0-970 kPa/min for pressure mode direct injection. • Programmed rate setting range to be -400 to 400 kPa/min for split/splitless mode, pressure mode and flow rate mode injections. • Flow rate setting range to be 0 to 1200 ml/min for flow rate mode injection. • Should have at least 7 programmable steps. Specifications for Liquid mode: • In liquid mode, syringe sizes must be from 1.2, 5, 10, 25, 100, 250 and 500 micro liters. • The injection speed selection must be from 0.01ul/sec. up to 250ul/sec. • GC liquid mode has capacity up to 600 1ml micro vials and should be able to hold 2ml, 10 ml and 20 vials as well as different micro plates. • For syringe cleaning, it should have a workstation for 2 different solvents and standard. Specifications for Head Space mode: • In headspace mode, syringe sizes must be 1ml, 2.5ml and 5 ml. • Injection speed to be selectable from 10 ul/sec. up to 1 ml/sec. • Sample capacity to be about 300 2ml standard vials, about 100 10ml or 20 ml vials. • Cleaning of syringes must be by inert gas purging. • Heated syringe to be 30C to 150C selectable in 1C increments, • Should have incubator oven with at least 6 heated vial positions. • Incubation temperature should be 30C -200C in 1C increments. • Should be able to agitate with interval shaking 250rpm-750rpm selectable in 1 rpm increments, • Incubation time up to 999 minutes selectable in one second increments. Specifications for Solid Phase Micro Extraction (SPME) mode: • Specification requirements are the same as in case of Head Space mode for Sample capacity, Incubator oven, incubator temperature and Agitation. • Extraction time is up to 999 minutes selectable in 1 second increment Regulatory Issue: • Equipment package must include Installation and Operational Qualifications work, document and meet the FDA/USP guidelines as listed above. Utility Requirements • GC main unit should have AC100V/120V power requirement. The intended procurement will be classified under the North American Industrial Classification (NAIC) code 334516 with a size standard of 500. All respondents are requested to identify their firm's size and type of business. Interested firms must also provide descriptive literature or other materials that demonstrates their ability to meet the forgoing requirements along with their capability statements. Firms with the capability of providing the required equipment as listed above and can demonstrate experience in carrying out Installation and Operational Qualifications for the instrument to withstand FDA inspection (Guidance for Industry Manufacturing, Processing, or Holding Active Pharmaceutical Ingredients) are required to submit a capability statement to assist the Government in determining in accordance with Federal Acquisition Regulation (FAR) 19.502(b) whether or not this procurement will be set aside for any of the programs described above. The capability statement should not exceed 25 pages and be in sufficient detail so that the Government can determine the experience of your firm to provide the requirements above. Capability statement must be received no later than 3:00 PM EST on June 25, 2010 and can be either hand delivered to: Mr. Brian J. Lind Contract Specialist 6707 Democracy Boulevard Suite 106F Bethesda, MD 20892 Or by email at Lindbj@cc.nih.gov. This notice is a market survey and is for information and planning purposes only and does not commit the Government to any contractual agreement. This Is Not a Request for Proposals. The Government will not award a Purchase order or Contract based upon vendor responses to this announcement. The Government shall not assume any costs for preparing or submitting any information in response to the market survey or the Government's use of the information. Any proprietary information should be clearly identified as "proprietary information"
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/CCOPC/P176385/listing.html)
- Place of Performance
- Address: National Institutes of Health, 10 Center Drive, Room 1N-249, bethesda, Maryland, 20892, United States
- Zip Code: 20892
- Zip Code: 20892
- Record
- SN02176132-W 20100613/100611235450-266c83bcb74c6f243c1f14edc391ee3b (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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