SOURCES SOUGHT
66 -- Inline AutoDilution System for NexION 300 Inductively Coupled Plasma-Mass Spectrometry (ICP-MS) - FDA-SS-1164289
- Notice Date
- 4/7/2016
- 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 - Rockville, 5630 Fishers Lane, Room 2129, Rockville, Maryland, 20857-0001, United States
- ZIP Code
- 20857-0001
- Solicitation Number
- FDA-SS-1164289
- Archive Date
- 4/29/2016
- Point of Contact
- Lisa K. Yaw, Phone: 240-402-4018
- E-Mail Address
-
lisa.yaw@fda.hhs.gov
(lisa.yaw@fda.hhs.gov)
- Small Business Set-Aside
- Total Small Business
- Description
- Inline AutoDilution System for NexION 300 Inductively Coupled Plasma-Mass Spectrometry (ICP-MS) Inline AutoDilution System for NexION 300 Inductively Coupled Plasma-Mass Spectrometry (ICP-MS) NOTE: 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, which is 334516, Analytical Laboratory Instrument Manufacturing. The associated small business standard is 500 employees. Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. An organization that is not considered a small business under the applicable NAICS code should not submit a response to this notice. 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 it submits. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published in Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation. 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). Background The Division of Product Quality Research (DPQR) has an important regulatory research role evaluating metal impurities in pharmaceutical drug products. ICP-MS is the latest instrument to detect metal impurities in sub parts per trillion (ppt) levels. Currently DPQR has an ICP-MS installed which is being used for several regulatory projects. Currently, the preparation time for samples (calibration, quality controls and unknowns) is quite significant and requires a substantial amount of manual intervention. DPQR requires an inline auto dilution system to dilute the samples in automated fashion for the ICP-MS. This instrument will help facilitate DPQR's mission of providing valuable laboratory-based analysis of pharmaceutical products including emerging products in biotechnology. Objective To detect metals in pharmaceutical samples in parts per billion and trillion range with minimal manual intervention. Scope It has become essential for the pharmaceutical industry to use ICP-MS to detect metal impurities due to recent USP<232> and USP <233> chapters. The purpose of an inline dilution instrument is to perform all of these steps automatically, which decreases analysis time and enhances operational productivity. The system will also support the sample preparation application in biotechnology and pharmaceutical chemistry programs to identify and detect metal impurities at very low concentrations. An inline auto-dilution instrument is required that will interface with the Division's current Nexion 300 Inductively Coupled Plasma-Mass Spectrometry (ICP-MS) and be operationally controlled by the ICP-MS control operating software with the following specifications: • Able to auto dilute, auto calibrate and dilute QCs (with inline internal standard mixing) • 4-Syringe pump dilution module (S400V) • Peltier cooled SSI spray chamber • DXi micro peripump • Integrated high speed valve • Sapphire injector • PFA nebulizer • Instrument cart approximately 24" X 14"X 36" • Software should be included that will interface with the existing Perkin-Elmer NexION 300D instrument control software and includes applicable software upgrades ANTICIPATED PERIOD OF PERFORMANCE Component to be delivered within 30 days of contract award to the FDA White Oak Campus in Silver Spring, MD. PRICING AND PAYMENT: This requirement is anticipated to be a firm-fixed-price order, inclusive of all costs, such as labor, materials, shipping, and travel costs, with firm-fixed-price payment upon completion of specified deliverables. CAPABILITY STATEMENT/INFORMATION SOUGHT The FDA is requesting interested qualified small businesses to provide a capability statement showing their ability and willingness to complete this requirement electronically to Lisa Yaw at Lisa.Yaw@fda.hhs.gov in a commonly used format, such as Microsoft Word or pdf. This capability statement shall be no more than five pages, excluding a cover page and table of contents, and shall include examples of successfully completing relevant similar work, including a description of the similar work and client contact information. The FDA will be determining capability based on the ability to perform the tasks delineated above. Interested eligible small businesses shall also include company information to determine eligibility, including their contact information, Dun and Bradstreet (DUNS) number and size and business type (e.g. 8(a), HUBZone, etc.) based on the applicable NAICS code for the proposed acquisition Analytical Laboratory Instrument Manufacturing. The associated small business standard is 500 employees. Entities have until 2 pm ET
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/FDA-SS-1164289/listing.html)
- Place of Performance
- Address: Silver Spring, Maryland, 20993, United States
- Zip Code: 20993
- Zip Code: 20993
- Record
- SN04077090-W 20160409/160407235145-d2f714e7b428e922a20423ce479558fb (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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