SOLICITATION NOTICE
66 -- ARS M840 AUTOMATED SAMPLER - Description of Supplies & Services
- Notice Date
- 7/6/2011
- 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, Bldg 50 Room 422, Jefferson, Arkansas, 72079, United States
- ZIP Code
- 72079
- Solicitation Number
- 1088708
- Archive Date
- 7/28/2011
- Point of Contact
- Thomas M Dumas, Phone: 404-253-1253
- E-Mail Address
-
thomas.dumas@fda.hhs.gov
(thomas.dumas@fda.hhs.gov)
- Small Business Set-Aside
- N/A
- Description
- Description of Supplies & Services THIS IS A COMBINED SYNOPSIS/SOLICITATION FOR COMMERCIAL ITEMS PREPARED IN ACCORDANCE WITH THE FORMAT IN FAR SUBPART 12.6, IN CONJUNCTION WITH FAR 13.5, AND AS SUPPLEMENTED WITH ADDITIONAL INFORMATION INCLUDED IN THIS NOTICE. THIS ANNOUNCEMENT CONSTITUTES THE ONLY SOLICITATION; PROPOSALS ARE BEING REQUESTED AND A WRITTEN SOLICITATION WILL NOT BE ISSUED. THE SOLICITATION NUMBER IS 1088708. THIS SOLICITATION IS ISSUED AS A REQUEST FOR QUOTE (RFQ). QUOTATIONS ARE DUE 7 DAYS FROM THE PUBLICATION DATE OF THIS SYNOPSIS OR 13 JULY 2011, BY 1:00 P.M. EST AT THE FOOD AND DRUG ADMINISTRATION, ATTN: THOMAS DUMAS, 60 8TH ST., NE, ATLANTA, GA 30309 OR thomas.dumas@fda.hhs.gov. THE QUOTATION MUST REFERENCE SOLICITATION NUMBER 1088708. THE OFFERS ARE DUE IN PERSON, BY MAIL OR EMAIL. THE SOLICITATION DOCUMENT AND INCORPORATED PROVISIONS AND CLAUSES ARE THOSE IN EFFECT THROUGH FEDERAL ACQUISITION CIRCULAR (FAC) 2005-53, EFFECTIVE JULY 5, 2011. THE ASSOCIATED NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE IS 334516 - ANALYTICAL LABORATORY INSTRUMENT MANUFACTURING AND BUSINESS SIZE STANDARD IS 500 EMPLOYEES. THE FOOD AND DRUG ADMINISTRATION OFFICE OF ACQUISITIONS AND GRANTS SERVICES INTENDS TO AWARD A FIRM FIXED-PRICE PURCHASE ORDER FOR ONE (1) ARS M840 AUTOMATED SAMPLING SYSTEM WITH INTERFACE TO AGILENT HPLC SYSTEM BRAND NAME OR EQUAL TO INCLUDE FOUR (4) ONE YEAR OPTIONS FOR PREVENTIVE MAINTENANCE. OPTIONS WILL NOT BE EXERCISED AT THIS TIME. DESCRIPTION OF SUPPLIES & SERVICES (SEE ATTACHMENT FOR DESCRIPTON) The FDA has a requirement for ARS-M840 Automated Sampler or equivalent. It is imperative to have a parallel auto sampler system with individual control of each vessel to monitor critical parameters during protein production. Online and at line capabilities will allow the use of PAT tools to characterize the bioreactor environment during the process. A parallel system is necessary to allow the simultaneous experimentation of multiple variables to perform design of experiments (DOE) and utilize QbD. With follow-on-biologics or biosimilars on the way, DPQR wishes to characterize the protein production process to understand critical variables and utilize PAT and QbD techniques. Salient Characteristics of instrument: • A parallel system capable of sampling from at least 8 bioreactors system with the ability to extract cell containing samples for analyzers that utilize them (i.e. cell counter, nutrient analyzer) and able to remove cells for analyzers that need to be cell free (i.e. HPLC) • Utilize a sanitary sampling interface, located near the bioreactors to clean the sample transfer lines and the valves in the module and provides complete isolation of the reactor from the system to allow cleaning and flushing directly to the reactor port to protect the reactor from contamination. Multiple isolation valves should be in series with at least one drain valve and must be controlled automatically by the system. Capable of delivering the samples to at least 4 separate analytical or storage instruments. • Capable of performing dilutions prior to delivery to external analytical instruments such as cell counters or adding selected buffer to samples prior to HPLC analysis. • Flexibility in the analytical output to allow online analysis by a number of different analytical methods such as High Performance liquid chromatography, nutrient monitoring devices, cell counters and sample collection/storage apparatus. • Capable of physical and software integration of optional 3rd party software and accessories such as a Dasgip Bioreactor through OPC control to allow automated sampling and the creation of a feedback loop to incorporated into system's controls. • Clean in place capabilities to prevent microbial contamination using 0.22 micron filtered prepackaged reagents for quick and aseptic installation. • Provide a physical and OPC software interface for a NOVA nutrient analyzer to allow sample delivery and OPC feedback of the values • Provide a physical and OPC software interface for an Agilent High performance liquid chromatography (HPLC) system with in line filtration of cells prior to sample delivery and OPC feedback of the values. • Provide an aseptic sample collection device capable of maintaining at least 60 samples at 4C. The following FAR clause applies to this solicitation and is incorporated by full text: 52.211-6 BRAND NAME OR EQUAL (AUG 1999) (a) If an item in this solicitation is identified as "brand name or equal," the purchase description reflects the characteristics and level of quality that will satisfy the Government's needs. The salient physical, functional, or performance characteristics that "equal" products must meet are specified in the solicitation. (b) To be considered for award, offers of "equal" products, including "equal" products of the brand name manufacturer, must- (1) Meet the salient physical, functional, or performance characteristic specified in this solicitation; (2) Clearly identify the item by- (i) Brand name, if any; and (ii) Make or model number; (3) Include descriptive literature such as illustrations, drawings, or a clear reference to previously furnished descriptive data or information available to the Contracting Officer; and (4) Clearly describe any modifications the offeror plans to make in a product to make it conform to the solicitation requirements. Mark any descriptive material to clearly show the modifications. (c) The Contracting Officer will evaluate "equal" products on the basis of information furnished by the offeror or identified in the offer and reasonably available to the Contracting Officer. The Contracting Officer is not responsible for locating or obtaining any information not identified in the offer. (d) Unless the offeror clearly indicates in its offer that the product being offered is an "equal" product, the offeror shall provide the brand name product referenced in the solicitation. EVALUATION AND AWARD: The Government intends to evaluate proposals and, if necessary conduct discussions with all responsible offerors within the competitive range. The award will be made to the offeror whose proposal conforms to the terms and conditions of the solicitation and award may be made to other than the lowest priced or the highest technically rated offer. Relative importance and trade-offs. The Government will base the determination of best value on performance, and the other evaluation factors identified elsewhere in this solicitation. The determination of best value also considers the relative importance of the evaluation factors. All evaluation factors when combined are approximately equal to cost and price. The technical quotations will receive paramount consideration over cost and past performance; however, cost will be evaluated for price reasonableness. The Government reserves the right to make its decision on the basis of initial quotations received and not have discussions. Therefore, each initial quotation should contain the offeror's best terms from both a price and technical standpoint. Offerors shall include technical specifications, descriptive material, literature, brochures and other information corresponding to each minimum required item, which demonstrates the capabilities of the offerors equipment. The Government is not responsible for locating or securing any information, which is not identified in the proposal. Offerors must include a complete copy of the provisions at FAR 52.212-3, Offeror Representations and Certifications - Commercial Items with its offer. Applicability of FAR PROVISIONS: THE FOLLOWING FEDERAL ACQUISITION REGULATION (FAR) PROVISIONS AND CLAUSES APPLY TO THIS REQUEST FOR QUOTES AND ARE INCORPORATED BY REFERENCES: 52.212-1, INSTRUCTIONS TO OFFERORS-COMMERICAL (JUN 2008), 52.212-4 CONTRACT TERMS AND CONDITIONS-COMMERCIAL ITEMS (JUN 2010). 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT STATUES OR EXECUTIVE ORDERS-COMMERCIAL ITEMS (APR 2011); THE FOLLOWING CLAUSES ARE APPLICABLE: 52.219-28; 52.222-3; 52.222-19; 52.222-21; 52.222-26; 52.222-35; 52.222-36; 52.222-37; 52.222-50; 52.225-1; 52.225-3; 52.225-13, AND 52.232-33. FULL TEXT OF CLAUSES AND PROVISIONS CAN BE OBTAINED AT http://www.acquisition.gov 52.217-8 Option to Extend Services (NOV 1999) The Government may require continued performance of any services with the limits and at the rates specified in the contract. These rates may be adjusted only as a result of revisions to prevailing labor rates provided by the Secretary of Labor. The option provision may be exercised more than once, but the total extension of performance hereunder shall not exceed 6 months. The Contracting Officer may exercise the option by written notice to the Contractor within 1 day of contract expiration. (End of Clause) 52.217-9 Option to Extend the Term of Contract (MAR 2000) (a) The Government may extend the term of this contract by written notice to the Contractor within 1 day of contract expiration; provided that the Government gives the Contractor a preliminary written notice of its intent to extend at least 30 days before the contract expires. The preliminary notice does not commit the Government to an extension. (b) If the Government exercises this option, the extended contract shall be considered to include this option clause. (c) The total duration this contract, including the exercise of any options under this clause shall not exceed 60 months. (End of Clause) 52.232-19 Availability of Funds for the Next Fiscal Year (APR 1984) Funds are not presently available for performance under this contract beyond one (1) year from receipt of supplies or services. The Government's obligation for performance of this contract beyond that time is contingent upon availability of appropriated funds from which payment for contract purposes can be made. No legal liability on the part of the Government for any payment may arise for performance under this contract beyond one (1) year from receipt of supplies or services until funds are available to the Contracting Officer for performance and until the Contractor receives notice of availability of funds, to be confirmed in writing by the Contracting Officer. (End of Clause) CCR Requirement - Offeror's must be registered in the Central Contractor Registration (CCR) before an award can be made. If offeror's are not registered in CCR, they may do so by accessing the CCR web site at: http:www.ccr.gov. A standard commercial warranty on parts and workmanship is required. The Defense Priorities and Allocation System (DPAS) and assigned are not applicable to this solicitation notice.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/NCTR/1088708/listing.html)
- Place of Performance
- Address: Food and Drug Administration, White Oak Campus, 10903 New Hampshire Ave, Silver Spring, Maryland, 20993, United States
- Zip Code: 20993
- Zip Code: 20993
- Record
- SN02490746-W 20110708/110706234955-bdc2a51a8c3253ab19ec03d26330b32b (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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