SOLICITATION NOTICE
66 -- prepFAST 4DX Inline Autodilution System or equal - FDA-RFQ-1164289
- Notice Date
- 4/15/2016
- 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 - Rockville, 5630 Fishers Lane, Room 2129, Rockville, Maryland, 20857-0001, United States
- ZIP Code
- 20857-0001
- Solicitation Number
- FDA-RFQ-1164289
- Archive Date
- 5/7/2016
- Point of Contact
- Lisa K. Yaw, Phone: 2404024018
- E-Mail Address
-
lisa.yaw@fda.hhs.gov
(lisa.yaw@fda.hhs.gov)
- Small Business Set-Aside
- N/A
- Description
- prepFAST 4DX Inline Autodilution System Part 1 - Description FDA/DPQR requires a prepFAST 4DX inline auto dilution system or equal to dilute samples in automated fashion for the ICP-MS. This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Federal Acquisition Regulation (FAR) Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested, and a separate written solicitation will not be issued. This solicitation is a Request for Quote (RFQ) using FAR Parts 12 and 13 procedures. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2005-87. The North American Industry Classification System (NAICS) code for the proposed acquisition is 334516, Analytical Laboratory Instrument Manufacturing. The associated small business standard is 500 employees. This requirement is for full and open competition. Part 2 - Supplies or Services and Prices/Costs Purchase Order Type: Firm-Fixed Price Base Year Manufacturer Product Code Description Quantity Price prepFAST 4DX Inline Autodilution System or equal Installation and training Shipping One (1) year warranty on parts, labor, and travel Total Firm-Fixed Price Part 3 - Description/Specifications 3.1 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. 3.2 Statement of Work/Salient Characteristics 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 The instrument shall perform the following: 1. Delivery, Installation, Training and Warranty: • Installation shall include of the installation of the system and all components, as well as calibration, quantification, and software installation. • Shall include a demonstration/training for lab personnel. • Shall include a warranty for at least one (1) year from date of installation which covers all labor, parts, and travel expenses required for repairs for equipment and software. Technical support and troubleshooting assistance shall be provided via phone, email, or live-chat interface. Part 4 -Performance and Deliverables 4.1 Place of Performance and Work Hours All applicable equipment is located at the location listed below. Normal workdays are Monday through Friday except US Federal Holidays. Work hours are typically from 8 am to 5 pm (et). Service visits shall be coordinated with TBD, see below. Location and Point of Contact: Food and Drug Administration White Oak Campus 10903 New Hampshire Avenue Silver Spring, MD 20993 ATTN: TBD The instrument will be delivered to the WO Bldg 62 Loading Dock and transported to WO bldg 64 room 1033 for installation, integration, and assembly. 4.2 Period of Performance The equipment shall be delivered by June 1, 2016. The warranty shall start when equipment is installed and accepted by FDA and be in effect for one year.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/FDA-RFQ-1164289/listing.html)
- Place of Performance
- Address: White Oak Campus, Silver Spring, Maryland, 20993, United States
- Zip Code: 20993
- Zip Code: 20993
- Record
- SN04086238-W 20160417/160415234845-40716b5fee7a438e83183930d8d76b5f (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
| FSG Index | This Issue's Index | Today's FBO Daily Index Page |