SOURCES SOUGHT
66 -- Coulometric Karl Fischer Titration System
- Notice Date
- 7/17/2014
- 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-14-1135607-SS
- Archive Date
- 8/7/2014
- Point of Contact
- Tiffany R. Williamson,
- E-Mail Address
-
tiffany.williamson@fda.hhs.gov
(tiffany.williamson@fda.hhs.gov)
- Small Business Set-Aside
- N/A
- Description
- Sources Sought Synopsis Notice to Small Businesses The purpose of this notice is to obtain information regarding the availability and capability of qualified small business concerns. The Food and Drug Administration intends to provide maximum practicable opportunities in its acquisitions to small businesses. 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 that has the capability to provide a Coulometric Karl Fisher Titration System. 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 of 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. Brand Name or Equal: This is a BRAND NAME OR EQUAL acquisition; in accordance with FAR 52.211-6, to be considered for award, offers of equal products must meet the salient physical, functional, or performance characteristics provided in the statement of requirements. In order to be considered an "equal" solution, any alternative solution proposed must be able to perform in strict accordance with the salient operational and technical features described below. Background The United States Food and Drug Administration (FDA), Office of Regulatory Affairs (ORA)'s Pacific Regional Laboratory- Southwest (PRL-SW) protects consumers by ensuring the safety and efficacy of food, pharmaceuticals (drugs), medical devices, and cosmetics. PRLSW's Drug Chemistry Section analyzes several pharmaceutical (drug) samples in a Fiscal Year to ensure that they meet acceptance criteria. Objectives/Scope FDA/ORA/PRL-SW Laboratory performs regulatory testing of pharmaceutical samples. Tests include identification, assay, content uniformity, impurities quantification and dissolution methods. The Drug Chemistry Section gets regulatory samples which requires the use of Coulometric Karl Fischer (KF) Titration System with Accessories and also requires the use of Auto Acid-Base Titration System with Accessories. Currently, the Drug Chemistry Section does not have any Coulometric KF Titration System or any Automatic Acid-Base Titration System, and therefore, there is a need to purchase these two Titration Systems to perform regulatory analyses. Specific Tasks and Deliverables: Item 1: Quantity = 1 Mettler Toledo Coulometric Karl Fischer (KF) Titration System C20X (Product # 51105512) or Equal The contractor shall supply FDA/ORA/PRL-SW Laboratory with a Coulometric Karl Fischer (KF) Titration System with Accessories which meet the following specifications: 1. Single click user interface - Large (Minimum Specifications: VGA 5.7" TFT, 320 x 240 pixel) color touch screen must have user interface with shortcut button features 2. Pump System - This pump system must have a liquid handling device which protects users against contact with chemicals. This liquid handling device must be fully controlled by the titrator and must offer the possibility of removing the reagents with minimal user interaction. 3. This system must offer to user the choice of use of generator cell with or without diaphragm. Although most samples can be conveniently analyzed with the cell without diaphragm, the diaphragmless cell must also suit the need for very precise low water content determinations. 4. Shall have connectivity to common USB printers. 5. Must have an integrated magnetic stirrer system. Accessories Include: 1. Brother's printer laserjet or equal 2. Solvent Manager Set to protect users from contact with chemicals 3. EQPac Comprehensive Qualification 4. Calibrate SCC Mettler Toledo Automatic Acid-Base Titration System T50A (Product # 51109002) or Equal The contractor shall supply FDA/ORA/PRL-SW Laboratory with an Automatic Acid-Base Titration System with Accessories which meet the following specifications: 1. Terminal with Touchscreen - Screen that can be positioned via cable connection. This must be coupled with an adjustable display angle. 2. Sensor & Burette Operation - Titration operation must be with minimum user intervention. Important data such as sensor calibration and/or titrant concentration must be saved in the sensor and burette chip and must automatically be transferred to the titrator. 3. Must have connectivity to common USB printers. 4. Shall include software for the Automatic Acid-Base Titration System. Software shall: a. Be compatible with the Automatic Acid-Base Titration System b. Be able to take full control over the titrator, allow secure database archiving and allow for result management with control charts. c. Store data and results in a format which can be exported to third-party programs, such as Laboratory Information Management System (LIMS) software, Microsoft Excel, etc. d. Be compatible with McAfee Anti-Virus programs. e. Perform the initial configuration of system. f. Allow for Average and Standard Deviation statistical calculations. Accessories Include: 1. Burette DV1010 10mL 2. pH Sensor DG115-SC 3. LabX Titration Express 4. EQPac Comprehensive Qualification 5. Calibrate SCC 6. Certify Initial EA - 2nd burette Warranty: 1. Price must include a 12 month warranty agreement for all parts and labor. 2. The vendor shall provide an additional 2 years of Preventative Maintenance Service on the instrument, software, and computer system. 3. Direct and trained service employees of the successful offeror shall provide maintenance and repair service. A toll-free telephone number for placing service calls is required. Expected response time for a service call is within 1 business day from Monday to Friday during the hours of 8:00 am to 5:00 pm Pacific Time. Installation: Only trained service personnel shall provide full system installation. Performance qualification (IQ/OQ/PQ) shall be performed on the entire system. Training: The contractor shall provide familiarization training for three to five analysts upon installation. General Requirements: 1. The equipment supplied shall be new equipment and must meet manufacturer's performance standards for new equipment. 2. The new equipment shall not have been used previously, actively marketed as a new model and contains no used components or parts. Remanufactured, refurbished, or reconditioned equipment is not acceptable. 3. The system shall be delivered with all necessary supplies and accessories required for installation and start-up. The contractor shall deliver and install (IQ/OQ) ONE Coulometric Karl Fischer (KF) Titration System with Accessories and ONE Automatic Acid-Base Titration System with Accessories that meet the above listed specifications, including equipment, software, and IQ/OQ documents. The contractor shall also provide manufacturer's certificates and licenses related to LabX Tritration Express software. Also, the contractor shall provide system management and user manual(s) in electronic and paper form and shall perform initial configuration of the system. Delivery Timeframe 90 days after receipt of award Delivery shall be made Monday - Friday, 8:00 am to 4:00 pm, except for federal holidays. 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 characteristics listed above to the Contracting Officer (i.e. brochure, information on equipment that meets specifications, etc.) The capability statement must also 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-14-1135607-SS. Responses must be submitted via email to Tiffany Williamson at Tiffany.Williamson@fda.hhs.gov by 12:00 pm on July 23, 2014.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/FDA-14-1135607-SS/listing.html)
- Place of Performance
- Address: Southeastern Regional Laboratory (SRL), U.S. Food and Drug Administration, 19701 Fairchild, Irvine, California, 92612, United States
- Zip Code: 92612
- Zip Code: 92612
- Record
- SN03429140-W 20140719/140717235808-1ebdffc04fedf001c67da925c1b7d22c (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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