SOURCES SOUGHT
66 -- Bath Dissolution with UV/Vis Detector, Auto-Sampler, Installation, Training, and Post-Warranty Services
- Notice Date
- 7/26/2016
- 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_16-223-SOL-1169407
- Archive Date
- 8/17/2016
- Point of Contact
- Howard Nesmith, Phone: 870-543-7459
- E-Mail Address
-
howard.nesmith@fda.hhs.gov
(howard.nesmith@fda.hhs.gov)
- Small Business Set-Aside
- Total Small Business
- Description
- THIS IS A SOURCES SOUGHT ANNOUNCEMENT, A MARKET SURVEY FOR WRITTEN INFORMATION ONLY. THIS IS NOT A SOLICITATION ANNOUNCEMENT FOR PROPOSALS AND NO CONTRACT WILL BE AWARDED FROM THIS ANNOUNCEMENT. NO REIMBURSEMENT WILL BE MADE FOR ANY COSTS ASSOCIATED WITH PROVIDING INFORMATION IN RESPONSE TO THIS ANNOUNCEMENT OR ANY FOLLOW-UP INFORMATION REQUESTS. NO TELEPHONE CALLS WILL BE ACCEPTED REQUESTING AN RFQ PACKAGE OR SOLICITATION. THERE IS NO RFQ PACKAGE OR SOLICITATION. IN ORDER TO PROTECT THE PROCUREMENT INTEGRITY OF ANY FUTURE PROCUREMENT, IF ANY, THAT MAY ARISE FROM THIS ANNOUNCEMENT, INFORMATION REGARDING THE TECHNICAL POINT OF CONTACT WILL NOT BE GIVEN AND NO APPOINTMENTS FOR PRESENTATIONS WILL BE MADE. The U.S. Food and Drug Administration (FDA), Office of Acquisitions and Grants Services (OAGS) has issued this sources sought announcement on behalf of the Office of Regulatory Affairs (ORA), Detroit Laboratory (DET-LAB), requires a Bath Dissolution with UV/Vis Detector, Auto-Sampler, Installation, Training, and Post-Warranty Services. If your firm is considered a small business source under North American Industry Classification System (NAICS) 334516 - Analytical Laboratory Instrument Manufacturing; with a Small Business Size Standard of 1,000 employees, and believe that your firm would be able to provide the FDA with the required System, Installation, and Post-Warranty Services as described below, please submit an email to howard.nesmith@fda.hhs.gov. The vendor shall include information about the company which demonstrates they can meet all of the minimum requirements. Background/Statement of Need: The FDA/ORA/DET-LAB has been scheduled to receive up to 60 investigative pharmaceutical medication samples per month collected primarily from Department of Defense and Veterans Administration stockpiles of medications, as well as from random locations for drug survey testing. The DET-LAB will also receive and process samples from FDA ORA District Offices across the nation. To accommodate a larger capacity on a monthly basis the DET-LAB requires an additional Bath Dissolution Instrument with UV/Vis spectrometer to run dissolution analyses on pharmaceutical medications for shelf life and drug survey samples. Minimum Technical Specifications: Dissolution System - Bench-top model - Automatic (Up to 100 Pre-Programmed Methods) - Shall store and sort up to 100 methods by name and create date - Serialize paddles and vessels - 7 Dissolution Vessels with programmable volume of 500 mL - 1000 mL - Digitally Controlled RPM Control - Built-in Calibration Probe - Manual Program Modes (Individual Vessel Control) - Shall have security and password protection - Interface Ports & Parallel Printer - Software shall comply with 21 CFR, Part 11 laboratory standards Sampler - Shall be capable of pulling samples from multiple baths and run samples through the UV/Vis - Shall include a Spectrometer - Shall include a Variable pump - Shall include a Flow cell with 10-mm path length, 3-mm diameter, and 80 µl volume - Shall include a constant-speed peristaltic pump with pump tubing - Shall include a Sample volume of approximately 1 ml - Shall include a typical sampling time of ~20 seconds with <1% cross-contamination - Shall include a Test Tube and HPLC Vial collection - Shall include an 8 Channel Syringe Pump - Shall include a Test Tube Rack - Shall include a HPLC Vial Rack UV/Vis Spectrometer - United States Pharmacopeia (USP) Compliance - Shall include a pre-aligned deuterium and tungsten lamp light sources - Shall include built-in buttons to measure sample, standard, and blank for measurements even when wearing gloves - Shall be thermally stable for a wide operating temperature range - Shall communication through GPIB or LAN for dedicated or networked PC control - Shall include a built-in interface for control of accessories - Shall include an internal clock for time and date stamps - Shall include self-test procedures which check the electronics and key optical characteristics to ensure consistent performance between validations - Shall include a built-in electronic logbooks which contain results of self-tests, instrument, maintenance, events and errors Optical Performance - Shall include wavelength range 190-1100 nm - Shall be US Pharmacopeia and American Society for Testing and Materials (ASTM) compliant Data System - Shall include a Dual Core computer - Shall include a 2.66 GHz processor or faster - Shall include at minimum 4GB RAM - Shall include at minimum 320 GB hard drive - Shall include an internal video card shall support a maximum resolution of 1920x1200 (DVI) and 2048 x 1536 (Analog) - Shall include no less than 3 network connections - Shall include a DVD RW (CD RW capable) - Shall include a Mouse and keyboard - Shall be Restriction of Hazardous Substances (RoHS) compliant - Shall include a color laser jet style printer - Shall include at minimum a 15" wide flat panel LCD display Software System - Software shall control the dissolution, spectrometer, and sipper sampler delivery system - Software shall control all parameters including but not limited to solvent flow rate, solvent composition, injection volume, bath position, bath temperature, switching valve(s) position - Pump shall be controlled from the UV/Vis spectrometer data system and software - Software shall provide data analysis including but not limited to peak detection, peak integration, quantification and data reporting Installation and Training - Shall provide full installation of the equipment - Shall provide Installation Qualification/Operational Qualification (IQ/OQ) and - Shall provide Instrument Performance Verification (IPV) which includes a qualification report - On-site training shall be conducted at the time of installation or scheduled no later than one (1) week after installation and successful qualification of instrument - Shall provide 8 hours of on-site training for up to 10 employees - Training shall include, but not limited to basic functions, operation of equipment, hardware and software integration, overview of the equipment, and the functionality of the equipment Post Warranty Services & Preventative Maintenance Agreement - Shall include unlimited corrective/remedial maintenance visits within 3 business days of call for service - Shall provide unlimited technical support access Mondays - Fridays (excluding Federal Holidays) between the hours of 8:00 AM - 5:00 PM Eastern Time. If the Government notifies the Contractor of a problem after 5:00 p.m. via the Internet or phone message, the vendor shall begin providing a solution to problem(s) reported within 8 business hours of contact for assistance. (e.g., telephone-based, email-based, website-based, etc.) - All maintenance and repair activities shall be performed by formally trained and certified technicians/engineers. All repairs and PM services shall be performed following Original Equipment Manufacturer (OEM specifications, manuals, and service bulletins, using OEM replacement parts, components, subassemblies, etc.- Proposed pricing for unlimited on-site service, repairs, and Preventative Maintenance (PM) services shall be inclusive of labor, travel, replacement parts, components, subassemblies, etc. - The PM Service plan shall include at least one (1) on-site visit for routine certification of the instrument per year. - Service plan shall include access to OEM technical developments, repair procedure bulletins, and unlimited software, firmware, and application updates. - Service Records and Reports The Contractor shall, commensurate with the completion of each service call or preventative maintenance visit, provide the end-user of the equipment and the Contracting Officer with a copy of a field service report/ticket identifying the equipment name, manufacturer, model number, and serial number of the equipment being serviced/repaired and detailing the reason for the service call, a detailed description of the work performed, the test instruments or other equipment used to affect the repair or otherwise perform the service, the name(s) and contact information of the technician who performed the repair/service, and for information purposes, the on-site hours expended and parts/components replaced. FOB Destination: U.S. Food and Drug Administration Office of Regulatory Affairs (ORA) Detroit Laboratory (DET-LAB) 300 River Place, Suite 6900 Detroit, MI 48207 Responses to this sources sought shall unequivocally demonstrate that the respondent is regularly engaged in the sale of same or substantially similar instruments, components, and post warranty services. Though the target audience is small business or small businesses capable of providing service from another small business, all interested parties may respond. At a minimum, responses shall include the following: - Business name and bio, DUNS number, business address, business website, business size status (i.e., SB, VOSB, SDVOSB, HUBZone SB, SDB, WOSB, LB), point of contact name, mailing address (if different from business address), phone number and email address. Provide this same information again if responding to provide a service offered by another firm. - Past Performance information for the manufacturer and/or sale of same or substantially similar instruments and services shall include date of sale, description, dollar value, client name, client address, client contact name, client point of contact mailing address (if different from that provided for client), client point of contact phone number, client point of contact email address, and name of the manufacturer (to include DUNS number and size status) if not the respondent. - Descriptive literature, brochures, marketing material, etc. detailing the nature of the instrument/components the responding firm is regularly engaged in manufacturing and/or selling. - If applicable, identification of the firm's GSA Schedule contract(s) by Schedule number and SINs that are applicable to this potential requirement are also requested. If a large business, provide if subcontracting opportunities exist for small business concerns. The Government is not responsible for locating or securing any information, not identified in the response. Interested Contractors must respond with capability statements in person, by e-mail, fax, mail or other delivery method before 1:00 pm (Central Standard Time - Local Prevailing Time in Jefferson, Arkansas) on August 2, 2016 to howard.nesmith@fda.hhs.gov, Fax (870) 543-7990, or mail to the U. S. Food and Drug Administration, OO/OFBA/OAGS/DAP, Attention of Howard Nesmith, 3900 NCTR Road, Building 50, Room 424, Jefferson, AR 72079-9502 and Reference: FDA_16-223-SOL-1169407. Disclaimer and Important Notes 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 submitted. After a review of the responses received, a pre‐solicitation synopsis and solicitation may be published in FedBizOpps. However, responses to this notice will not be considered adequate responses to a solicitation. 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). Additional Notes: If the stated requirements appear restrictive, please submit comments detailing the concern. Though this is not a request for quote, informational pricing for the service would be helpful.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/FDA_16-223-SOL-1169407/listing.html)
- Place of Performance
- Address: U.S. Food and Drug Administration, Office of Regulatory Affairs (ORA), Detroit Laboratory (DET-LAB), 300 River Place, Detroit, Michigan, 48207, United States
- Zip Code: 48207
- Zip Code: 48207
- Record
- SN04196176-W 20160728/160726234908-2432643a6da6f336bb648310b4b475cf (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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