SOURCES SOUGHT
66 -- Acquisition and installation of analytical high performance liquid chromatography (HPLC) system
- Notice Date
- 9/11/2014
- Notice Type
- Sources Sought
- NAICS
- 423450
— Medical, Dental, and Hospital Equipment and Supplies Merchant Wholesalers
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institute on Drug Abuse, Station Support/Simplified Acquisitions, 31 Center Drive, Room 1B59, Bethesda, Maryland, 20892
- ZIP Code
- 20892
- Solicitation Number
- HHS-NIH-NIDA(SSSA)-SBSS-14-739
- Archive Date
- 10/2/2014
- Point of Contact
- Farrin Stanton,
- E-Mail Address
-
farrin.stanton@nih.gov
(farrin.stanton@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- TITLE: Acquisition and installation of analytical high performance liquid chromatography (HPLC) system INTRODUCTION This is a Small Business Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding: (1) the availability and capability of qualified small business sources, (2) whether they are small businesses; HUBZone small businesses, service-disabled, veteran-owned small businesses; 8(a) small businesses; veteran-owned small businesses; woman-owned small businesses; or small disadvantaged businesses; and (3) their size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition. Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. This notice is issued to help determine the availability of qualified companies technically capable of meeting the Government requirement and to determine the method of acquisition. It is not to be construed as a commitment by the Government to issue a solicitation or ultimately award a contract. Responses will not be considered as proposals or quotes. No award will be made as a result of this notice. The Government will NOT be responsible for any costs incurred by the respondents to this notice. The notice is strictly for research and information purposes only. The information requested will assist the Government in determining the appropriate acquisition method, including whether a small business social-economic set-aside, competitive or non-competitive method is possible, and to determine the availability of qualified companies technically capable of meeting the Government's requirement. ALL organizations with the capability and availability to perform the requirement under the applicable NAICS code are invited to submit a response to this notice. NORTH AMERICAN CLASSIFICATION SYSTEM (NAICS) CODE 423450 Laboratory equipment, dental and medical, merchant wholesalers The analytical HPLC for quality control must be purchased and must be installed in the new cGMP analytical lab. The HPLC must detect any chemical and radiochemical impurity in the final formulated dose of the radiopharmaceutical before the radiochemist send up the dose to the radiopharmacist. The radiochemical purity shall be determined in conjunction with radioactivity detector, which shall be purchased separately from this order. Therefore, the HPLC system must have additional data acquisition channel other than optical UV(ultra violet) detector. The HPLC must convert analog voltage signal from the radioactivity detector with resolution better than 12 bit (4095 in decimal number).The contractor shall independently perform the following tasks. 1. The HPLC System must have a Photodiode array (PDA) detector which must meet the following specifications: a. An operator of this PDA detector must be able to obtain the UV spectrum ranging from c.a. 190 nm to c.a. 600 nm (nanometers) at any time points in the acquired chromatogram. b. The HPLC system must allow chromatograms to be recorded at more than one wavelength simultaneously. c. Flow cell should be replaced easily when damaged. d. The controlling PC must have electronic communication via either RS323 or LAN (Ethernet) or USB communication to the PDA detector and pumps device. e. Start of the acquisition of data must be handled by at least two events in the system. One event is an electrical signal generated by the injector valve. Another event is pressing a control tool provided on the user interface. f. The machine must be controlled by software which is capable of running on Microsoft Windows operating system Windows 7 or Windows 8. g. The standard deviation of the baseline, namely, noise level must be below ± 1x10 -3 AU at 254 nm. 2. The HPLC system must have an analog to digital converter that logs data into hard disk drive in addition to UV absorbance signal selected from PDA. More specifically, the system must provide an analog to digital converter to handle voltage signal ranging from 0 to 10 V coming from the existing radiation detector a. The analog to digital converter must have at least 12 bit resolution. b. The sampling rate of the analog to digital converter must be greater than 10 Hz. The sampling rate here includes the rate of the writing the data into the hard disk drive (non-volatile memory). c. In addition to UV chromatogram, this additional signal from the radiation detector must be plotted in the separate charting windows. Alternatively, the same chart must be able to display UV and radiation signal simultaneously. d. The software should be able to scale UV and radiation signal automatically such that the maximum of the biggest peak can be seen during the requisition of data. e. One must be able to select either UV or additional analog signal of the previous chromatogram and must be able to overlay the data while data is being plotted on a charting window. f. One must able to scale the horizontal axis (x-axis for time) and the vertical axis (y-axis for UV absorbance or radiation) automatically such that the entire data is visible in the charting window during real time data acquisition. 3. The HPLC System must have 2 HPLC Pumps which must meet the following specifications: a. Flow rate must range between 0 and 6 milliliters per minute (mL/min). b. Flow rate must have the accuracy of +/- 1% at approximately 2 mL/min. c. All fittings and tubing necessary to plumb the system must be included. d. The pump must be able to handle the back pressure up to 5 kpsi. e. The pump must have a built-in pressure sensor with settable upper and lower limits to monitor the performance of the system. f. The HPLC pump must be able to minimize pulsation by providing a mechanical solution such as pulse dampener. g. The HPLC pump system must use two pumps to change the mobile phase gradually and systematically. The pumps must be computer controlled to yield reproducible results. h. The HPLC pump system must have a mixing mechanism of mobile phases. 4. The software must demonstrate the following two features are implemented. a. One must be able to store a certain method with specific name. b. The customizable report template must be provided. User must be able to customize the format of the report template. c. The software should provide integration tools and manual peak picking tools. d. One must be able to download the method previously stored in the hard drive. e. One must be able to overwrite downloaded method by manually intervening directly from the control panel of the software. f. The software should show all important parameters such as flow rate, UV absorbance, and back pressure of the pump head. 5. The autosampler must meet the following requirements. a. The minimum injectable volume must be 10 µL. b. The area obtained with auto-injector for five consecutive runs must have relative standard deviation less than 2 %. c. The injector must be able to inject from 10 to 100 µL. d. The injector must have washing station where needle and transfer line to the syringe are washed. 6. The HPLC system must have one manual injector. a. The manual injector must trigger start of data acquisition on UV channel and radioactivity channel, and the software must start data logging upon manual injection. b. The area obtained from 5 standard must runs must have relative standard deviation of 3 % on UV absorbance chromatogram. c. The retention time of the 5 consecutive run must have less than 5 % relative standard deviation when the retention time of the compound is c.a. 5 minutes after the start of acquisition. 7. Delivery and Installation must be performed by the successful offeror. Upon delivery the vendor must install the equipment and perform an equipment function test in the presence of a NIMH radiochemist to ensure the equipment is fully functional. 8. The installation process will perform all necessary testing and supply documents to prove that the system is compliant with the PET Current Good Manufacturing Practice (CGMP) guidelines. The equipment vendor shall verify that the equipment is installed correctly (installation qualification (IQ)) and operates according to specifications (operational qualification (OQ)). Please refer to the page 11 of the FDA document, Guidance PET Drugs — Current Good Manufacturing Practice (CGMP), Small Entity Compliance Guide. The document can be obtained from the website below; http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM266640.pdf 9. The software must allow the user to automatically export the acquired data into an external hard disc drive for data archiving purpose. 10. The successful offeror must provide two days of equipment training, including software operation, to NIMH radiochemists. 11. Unlimited telephone support with regard to software and hardware concerns must be provided. 12. The following selection criteria will be used. a. NIMH will select the HPLC system that best accomplishes the requirements listed in section B of this document. b. A vendor that will provide excellent training on software and hardware to the operators, i.e. NIMH radiochemists, must be chosen. c. A vendor that promises immediate correspondence or communication when instruments failure occurs will be favored most. d. The price must be competitive in the market. e. A vendor who supplies the enough spare parts and tools for the repair of the HPLC system must be favored. Offers will be evaluated on the basis of current market price of the similar system with the same level of performance. CAPABILITY STATEMENT INFORMATION SOUGHT Respondents must provide, as part of their responses, clear and convincing documentation of their capability of providing the item(s) specified in this notice. Contractors that believe they possess the ability to provide the required must submit specific documentation of their ability to meet each of the project requirements to the Contract Specialist. Contractors must provide their Company Name, DUNS number, Physical Address, and Point of Contact Information. Interested organizations are required to identify their type of business, applicable North American Industry Classification System Code, and size standards in accordance with the Small Business Administration. The government requests that no proprietary or confidential business data be submitted in a response to this notice. However, responses that indicate the information therein is proprietary will be properly safeguarded for Government use only. Capability statements must include the name and telephone number of a point of contact having authority and knowledge to discuss responses with Government representatives. Capability statements in response to this market survey that do not provide sufficient information for evaluation will be considered non-responsive. When submitting this information, please reference the solicitation notice number. All capability statements sent in response to this Sources Sought Notice must be submitted electronically (via email) to Farrin Stanton, Contract Specialist, at Farrin.Stanton@nih.gov in MS Word format by or before the closing date of this announcement. All responses must be received by the specified due date and time in order to be considered. The response must be received on or before September 17, 2014 4:00pm, eastern time. CONCLUDING STATEMENTS Note: This notice does not obligate the Government to award a contract or otherwise pay for the information provided in the response. No proprietary, classified, confidential, or sensitive information should be included in your 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 review of the responses received, pre-solicitation and solicitation notices may be published in Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation. The solicitation release date is pending. The Government intends to negotiate a fixed-price purchase order. 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). Contracting Office Address: 6001 Executive Blvd, Bethesda, Maryland 20892 Place of Performance: NIMH Bldg 49 Rm B1C72 Bethesda, MD 20892 United States
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NIDA-2/HHS-NIH-NIDA(SSSA)-SBSS-14-739/listing.html)
- Place of Performance
- Address: NIMH, Bethesda, Maryland, 20892, United States
- Zip Code: 20892
- Zip Code: 20892
- Record
- SN03507887-W 20140913/140912000825-8d6d3487118f6e2fd12d62a8ea073464 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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