SOLICITATION NOTICE
66 -- Lyophilizer System with Four (4) 1-Year Option Periods for Post-Warranty Maintenance - FDA-14-223-SOL-1126970
- Notice Date
- 6/5/2014
- 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, 5630 Fishers Lane, Room 2129, Rockville, Maryland, 20857-0001
- ZIP Code
- 20857-0001
- Solicitation Number
- FDA-14-223-SOL-1126970
- Archive Date
- 7/11/2014
- Point of Contact
- Sondea R Blair, Phone: 8705437469, Nick Sartain, Phone: 8705437370
- E-Mail Address
-
sondea.blair@fda.hhs.gov, nick.sartain@fda.hhs.gov
(sondea.blair@fda.hhs.gov, nick.sartain@fda.hhs.gov)
- Small Business Set-Aside
- N/A
- Description
- Attachment 2 CAD Drawing of Area in Attachment 1 Attachment 1 Structural Space FDA-14-223-SOL-1126970 This is a combined synopsis/solicitation for commercial items prepared in accordance with the Federal Acquisition Regulation (FAR) format in Subpart 12.6, 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. This requirement is being issued in conjunction with FAR Part 13 Simplified Acquisition Procedures and FAR 13.5 Test Program for Certain Commercial Items. The solicitation number is FDA-14-223-SOL-1126970. This solicitation is issued as a Request for Quote (RFQ). The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2005-74 dated May 30, 2014. The associated North American Industry Classification System (NAICS) Code is- 334516 Analytical Laboratory Instrument Manufacturing; Small Business Size Standard is 500 employees. This RFQ is issued as full and open competition, i.e., not set-aside for small business. Contract Type: Commercial Item - Firm Fixed Price. REQUIREMENTS Part I: General Information A. Introduction The US Food and Drug Administration (FDA) Center for Biologics Evaluation and Research (CBER), Division of Biological Standards and Quality Control (DBSQC) requires a Lyophilizer with four (4) 1-Year option periods for post-warranty maintenance. B. Background CBER is working to enhance production of reference standards and testing reagents (i.e., reference materials) to increase capability of supplying influenza reference materials for mitigating the consequences of pandemic influenza. To accomplish the mission, DBSQC must be prepared to respond to a greater-than-normal demand for CBER reference materials thereby, being able to produce and distribute effective influenza vaccine products in response to an increased public health need. C. Scope The Contractor shall provide a Lyophilizer System, which at a minimum, shall meet the requirements set forth herein. The Contractor shall be responsible for inside delivery, installation, site cleanup, testing, installation qualification (IQ), operational qualification (OQ), on-site training, warranty support, and post-warranty maintenance. Part II: Work Requirements A. Minimum Technical Requirements The System shall: -Provide a vial capacity of 15,000 3 mL vials or 7,500 5 mL vials -Include a butterfly isolation valve between product and the condenser chambers -Have a hydraulic stoppering system -Include at least eight product thermocouples -Include a minimum of one condenser temperature probe -Include a minimum of one shelf temperature probe -Have a barometric end point process control software to perform pressure rise test for product dryness -Include product trays, with removable bottoms, for every shelf -Have a temperature deviation of less than or equal to a +/- 1°C temperature deviation between and across shelves during steady conditions at normal operational ranges -Include a minimum lowest shelf temperature of at least a -60 °C lowest shelf temperature in freeze mode, with a primary and a secondary drying shelf temperature range at least between -40 to 50°C -Have ability to drop shelf temperature from ambient temperature (~20 °C) to -40 °C within an hour and -60 °C within two hours; and pre-cool shelves during product loading -Have a condenser capacity of at least 60 L within 24 hours, and a lowest condenser temperature of at least -70 °C -Include a clean-room wall flange and all internal corners shall be rounded for ease of cleaning -Include a window in the product drying chamber to view product during freeze drying operations and a window in the condenser to view ice accumulation -Provide automated system control where inputs from sensors and device feedback are used to monitor and control freeze drying operations -Provide automated system control process safety steps to protect product and major lyophilizer components in the event of system failure and/or delay in reaching trigger set-points, this shall also include warning and alarm notices -Provide operators the ability to monitor and interact with automated system control and data acquisition components of the system so that lyophilization programs can be modified (during freeze drying operations) based on visual displays of process feedback -Provide operators with a safe and effective means for ice build-up removal from the condenser during back-to-back lyophilization runs and maintenance operations -Include an automated leak rate test and system function test to confirm the functionality of the lyophilizer -Provide operators the ability to backfill the product chamber with an inert gas at the end of cycle -Include capacitance manometers to measure primary vacuum in the product chamber - Include a vacuum sensor and be able to maintain an operational vacuum of at least 10 to 15 millitorr B. Installation Area Details Equipment measurements shall comply with filling suite measurements in the Government's facilities as set forth in Attachments 1 and 2 due to structural space constraints and further shall adhere to the following: a. The back of the lyophilizer shall not extend beyond the outside clean-room wall more than 5.46 feet (1,664 mm) so there is enough space to cart supplies between the back of the lyophilizer and the pillared wall b. The width of the lyophilizer shall not be more than 8.0 feet (2,438.4 mm); Variability in lyophilizer design and/or its placement may allow for the required clearance between the contracted lyophilizer and structural constraints and an adjacent lyophilizer c. If system design is modified to meet facility area of operation space requirements, the modifications shall address safety and efficiency of operations C. Inside Delivery, Installation, IQ/OQ, and Training -The contractor shall provide inside delivery, installation, and clean-up of the installation site for the entire system with documented IQ and OQ of the system, and on-site training -At a minimum, training shall include system operations (including software), calibration, basic and routine preventative maintenance procedures, and cleaning requirements -Building delivery physical limitations are set by the freight elevator that has a weight capacity of 5,000 lbs, door opening dimensions of 54" (wide) X 96" (height), and interior dimensions of 69" (wide) x 102" (length) with a wall rail installed at 34: AFF on three sides of the cab at 3"-4" off the wall which reduces clear space above 30" -Installation shall be inclusive of all labor, parts, installation kits, and travel expense D. Turn-Key System Offerors are expected to provide a turn-key solution which shall include, but not be limited to: -All hardware, components, interfaces, instrument computers, software, installation and installation engineering support, on-site familiarization and operation training, IQ and OQ required to meet these specifications and the FDA's stated need and intended use for these systems. E. Warranty and Post Warranty Service Requirements I. Warranty System shall be warrantied (inclusive of parts, labor, and travel expense) for 12 months following Government acceptance of the system. Acceptance will take place only after the system is installed and IQ, OQ and training have been completed to the satisfaction of the Government. II. Post-Warranty Maintenance (Option Periods 1-4) Line Items 1001 through 4001 At a minimum, the Contractor shall provide the following services during the option periods for post-warranty periods: -Not less than one (1) scheduled preventive maintenance visit annually inclusive of parts, travel, and labor expense. -Unlimited corrective/remedial maintenance visits within 3 business days of call for service. - Unlimited technical and troubleshooting support, Mondays - Fridays (excluding Federal Holidays) between the hours of 7:00 AM - 5:00 PM Eastern Time, within 8 business hours of contact for assistance (e.g., telephone-based, email-based, website-based, etc.) - Unlimited software and firmware updates. - All maintenance and repair activities shall be performed by formally trained and certified technicians/engineers, following Original Equipment Manufacturer (OEM) specifications, manuals, and service bulletins, using new OEM replacement parts, components, subassemblies, etc. - All pricing shall be inclusive of labor, travel, replacement parts, components, subassemblies, etc. Part III Supporting Information A. Place of Performance US Food and Drug Administration Center for Biologics Evaluation and Research 10903 New Hampshire Avenue Building 72, Room 5296 Silver Spring, MD 20832 B. Period of Performance Inside delivery, installation, testing, IQ, OQ, and on-site training shall be completed no later than 120 calendar days after award. Warranty shall commence upon acceptance of the system. Post-warranty annual maintenance, if exercised, shall commence, upon expiration of the warranty period and continue for a year, which may be extended in annual increments up to a maximum of four (4) years. Schedule of Items (See Attached) Solicitation Provisions FAR and HHSAR Clauses and Provisions incorporated by reference may be obtained at: https://www.acquisition.gov/far/ http://www.dhhs.gov/asfr/ogapa/acquisition/acquisitionpolicies.html The provision at FAR 52.212-1 Instructions to Offerors-Commercial Items applies to this solicitation. The following addenda apply: Offerors shall provide their DUNS number with their quote. The FDA is offering for trade-in credit, in as-is condition, a VirTis Genesis Lyophilizer, Item Number 315218, Serial Number 207758 for which the Contractor will be responsible for disconnection, removal and shipping of the current system from the premises. Trade-in credit, if any, shall be reflected in the Schedule of Items. Prices shall be inclusive of shipping and handling (inside-delivery required) and shall be quoted FOB Destination. Offered prices shall be valid through September 30, 2014. Offers will be evaluated for technical acceptability. Offerors shall submit sufficient technical information necessary for the Government to conclusively determine that the offered system and services meet all of the work requirements identified herein. Offerors shall also submit IQ, and OQ protocols specific to the Work Requirements and shall identify all non-tested design modifications proposed to meet the minimum technical requirements and space limitations. Failure to do so will render the offer technically unacceptable. Offerors are afforded the opportunity to inspect the site, to include the equipment to be traded-in, and designated installation area by contacting the Contract Specialist, Sondea Blair, sondea.blair@fda.hhs.gov, no later than June 16, 2014 to schedule an appointment. The period of performance for the option periods in any resultant award will be estimated based on the date of award, required delivery of the Lyophilizer System (inclusive of inside delivery, installation, site cleanup, IQ, OQ, and training), and the offered warranty period. If/when Option Period 1 is exercised, the periods of performance for all options will be firmed via bilateral modification. Note: This solicitation is being issued under the premise that the Contractor will certify that the service it will propose to fulfill this requirement is exempt from the Service Contract Act per the conditions set forth in FAR 52.222-48 & FAR 22.1003-4(c). If this is the case and the Contractor certifies that is exempt under the terms and conditions of 52.222-48, then clause 52.222-51 will flow per usual from this solicitation to the resulting order. In the event that a Contractor does not make this certification, traditional Service Contract Act clauses 52.222-41, and 52.222-43 shall be included in the resulting order award as well as Wage Determination WD 05-2103 (Rev.-13): http://www.wdol.gov/wdol/scafiles/std/05-2103.txt?v=13. FAR Provision Exemption from Application of the Service Contract Act to Contracts for Maintenance, Calibration, or Repair of Certain Equipment Certification (Feb 2009) (a) The offeror shall check the following certification: CERTIFICATION The offeror [ ] does [ ] does not certify that- (1) The items of equipment to be serviced under this contract are used regularly for other than Government purposes, and are sold or traded by the offeror (or subcontractor in the case of an exempt subcontractor) in substantial quantities to the general public in the course of normal business operations; (2) The services will be furnished at prices which are, or are based on, established catalog or market prices for the maintenance, calibration, or repair of equipment. (i) An "established catalog price" is a price included in a catalog, price list, schedule, or other form that is regularly maintained by the manufacturer or the offeror, is either published or otherwise available for inspection by customers, and states prices at which sales currently, or were last, made to a significant number of buyers constituting the general public. (ii) An "established market price" is a current price, established in the usual course of trade between buyers and sellers free to bargain, which can be substantiated from sources independent of the manufacturer or offeror; and (3) The compensation (wage and fringe benefits) plan for all service employees performing work under the contract are the same as that used for these employees and equivalent employees servicing the same equipment of commercial customers. (b) Certification by the offeror as to its compliance with respect to the contract also constitutes its certification as to compliance by its subcontractor if it subcontracts out the exempt services. If the offeror certifies to the conditions in paragraph (a) of this provision, and the Contracting Officer determines in accordance with FAR 22.1003-4(c) (3) that the Service Contract Act- (1) Will not apply to this offeror, then the Service Contract Act of 1965 clause in this solicitation will not be included in any resultant contract to this offeror; or (2) Will apply to this offeror, then the clause at 52.222-51, Exemption from Application of the Service Contract Act to Contracts for Maintenance, Calibration, or Repair of Certain Equipment-Requirements, in this solicitation will not be included in any resultant contract awarded to this offeror, and the offeror may be provided an opportunity to submit a new offer on that basis. (c) If the offeror does not certify to the conditions in paragraph (a) of this provision- (1) The clause in this solicitation at 52.222-51, Exemption from Application of the Service Contract Act to Contracts for Maintenance, Calibration, or Repair of Certain Equipment-Requirements, will not be included in any resultant contract awarded to this offeror; and (2) The offeror shall notify the Contracting Officer as soon as possible, if the Contracting Officer did not attach a Service Contract Act wage determination to the solicitation. (d) The Contracting Officer may not make an award to the offeror, if the offeror fails to execute the certification in paragraph (a) of this provision or to contact the Contracting Officer as required in paragraph (c) of this provision. The provision at FAR 52.212-2 Evaluation-Commercial Items is applicable to this solicitation. (a) The Government will award a contract resulting from this solicitation to the lowest priced, technically acceptable responsible offeror. The lowest priced offer will be evaluated first. If the lowest priced offeror is not technically acceptable, the next lowest priced offer will be evaluated and so on until a technically acceptable offer is determined. (b) Options. The Government will evaluate offers for award purposes by adding the total price for all options to the total price for the basic requirement (inclusive of trade-in credit). The Government may determine that an offer is unacceptable if the option prices are significantly unbalanced. Evaluation of options shall not obligate the Government to exercise the option(s). (c) A written notice of award or acceptance of an offer, mailed or otherwise furnished to the successful offeror within the time for acceptance specified in the offer, shall result in a binding contract without further action by either party. Before the offer's specified expiration time, the Government may accept an offer (or part of an offer), whether or not there are negotiations after its receipt, unless a written notice of withdrawal is received before award. The Provision at FAR 52.212-3, Offeror's Representations and Certifications - Commercial Items, applies to this acquisition. An offeror should complete only paragraph (b) of this provision if the offeror has completed the annual representations and certifications electronically at www.acquisition.gov. The clause at 52.212-4, Contract Terms and Conditions - Commercial Items applies to this acquisition. The following addenda apply: FAR Clause 52.252-2 Clauses Incorporated by Reference (Feb 1998) This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at this/these address(es): https://www.acquisition.gov/far/ http://www.dhhs.gov/asfr/ogapa/acquisition/acquisitionpolicies.html FAR Clause 52.217-9 Option to Extend the Term of the Contract (a)... within 1 day of contract expiration;.... at least 10 days before the contract expires... (c)...shall not exceed 4 years beyond the warranty expiration of the requirement under Item 1. FAR Clause 52.203-17 Contractor Employee Whistleblower Rights and Requirement to Inform Employees of Whistleblower Rights; FAR Clause 52.204-4 Printed or Copied Double-Sided on Postconsumer Fiber Content Paper; FAR Clause 52.223-6 Drug-Free Workplace; FAR Clause 52.225-8 FAR Clause 52.232-40 Providing Accelerated Payment to Small Business Subcontractors; FAR Clause 52.242-13 Bankruptcy HHSAR Clause 352.202-1 HHSAR Clause 352.203-70 HHSAR Clause 352.222-70 HHSAR Clause 352.223-70 HHSAR Clause 352.231-71 HHSAR Clause 352.242-71 Inspection and Acceptance The supplies and/or services delivered hereunder shall be inspected and accepted at destination by the Contracting Officer's Representative (COR) specified at award. If the supplies or services are acceptable, the COR shall promptly forward a report of inspection and acceptance to the paying office. If the supplies or services are not acceptable, the COR shall document the nonconforming items/services and immediately notify the contracting officer. Service Records and Reports The Contractor shall, commensurate with the completion of each service call (inclusive of warranty service), provide the end-user of the equipment 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. In addition, the Contractor shall provide monthly reports to the FDA COR and Contract Specialist, not later that the 5th work day following the end of each month, summarizing all maintenance and repair activities (including warranty work) for the previous month; negative reports are required. Invoice Submission Payment terms Net 30 days after government acceptance of the system (inclusive of inside delivery, site cleanup, installation, IQ, OQ and training). Post-warranty annual maintenance services will not be paid more frequently than monthly in arrears. There will be no advance or progress payments under this contract. Invoices shall be submitted to the address identified below and contain all necessary information per FAR 52.212-4 (g) in accordance with the following instructions. I. To constitute a proper invoice, the invoice must be submitted on company letterhead and include each of the following: (i) Name and address of the contractor; (ii) Invoice date and invoice number; (iii) Purchase order/award number; (iv) description, quantity, unit of measure, unit price, and extended price supplies delivered or services performed, including: (a) period of performance for which costs are claimed; (b) itemized travel costs, including origin and destination; and (c) any other supporting information necessary to clarify questionable expenditures; (v) Shipping number and date of shipment, including the bill of lading number and weight of shipment if shipped on government bill of lading, if applicable; (vi) Terms of any discount for prompt payment offered, if applicable; (vii) Name and address of official to whom payment is to be sent (must be the same as that in the purchase order/award, or in a proper notice of assignment) (viii) Name, title, and phone number of person to notify in event of defective invoice; (ix) Taxpayer identification number (TIN); (x) electronic funds transfer (EFT) banking information, including routing transit number of the financial institution receiving payment and the number of the account into which funds are to be deposited; (xi) name and telephone number of the FDA contracting officer representative (COR) or other program center/office point of contact, as referenced on the purchase order; (xii) Company's DUNS number; and (xiii) Any other information or documentation required by the purchase order/award. II. An original and two (2) copies shall be submitted to: Sondea Blair 3900 NCTR Road Building 50, Room 421 Jefferson, AR 72079 An electronic invoice can be emailed to the following address: sondea.blair@fda.hhs.gov III. One copy to the Contracting Officer Representative (COR) or other program center/office designee, clearly marked "courtesy copy only": To be completed at time of award by Government. IV. Questions regarding invoice payments should be directed to the FDA payment office at (870) 543-7446 or (870) 543-7042 or electronically at nctrinvoices@fda.hhs.gov The clause at FAR 52.212-5, Contract Terms and Conditions Required to Implement Statues or Executive Orders-Commercial Items apply to this acquisition. The following additional FAR clauses cited in this clause are applicable: (b): 52.203-6 Alt I, 52.204-10, 52.209-6, 52.219-4, 52.219-8, 52.219-28, 52.222-3, 52.222-19, 52.222-21, 52.222-26, 52.222-35, 52.222-36, 52.222-37, 52.222-40, 52.222-54, 52.223-18, 52.225-5, 52.225-13, and 52.232-33. (c): 52.222-51. All responsible sources may submit an offer, which if timely received, shall be considered. The offer must reference solicitation number FDA-14-223-SOL-1126970. The offers are due in person, by postal mail or email to the point of contact listed below on or before June 26, 2014 before 9:00 am (Central Time in Jefferson, Arkansas) at the Food and Drug Administration, FDA/OO/OFBA/OAGS/DAP, Attn: Sondea Blair, 3900 NCTR Road, HFT-320, Building 50, Room 421, Jefferson, AR 72079-9502. PLEASE NOTE - The above contact information is for the Contracting Office and not necessarily the delivery address. The delivery address is indicated in Part III Supporting Information section above. For information regarding this solicitation, please contact Sondea Blair by e-mail at sondea.blair@fda.hhs.gov. Questions regarding this solicitation, and requests for site visit, will be accepted only via email and shall be submitted no later than 9:00 AM Central Time on June 18, 2014. All answers to question submittal will be posted in an amendment on or before June 20, 2014. List of Attachments Attachment 1, Structural Space (1 Page) Attachment 2, CAD Drawing of Area in Attachment 1 (1 Page)
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/FDA-14-223-SOL-1126970/listing.html)
- Place of Performance
- Address: US Food and Drug Administration, Center for Biologics Evaluation and Research, 10903 New Hampshire Avenue, Building 72, Room 5296, Silver Spring, Maryland, 20832, United States
- Zip Code: 20832
- Zip Code: 20832
- Record
- SN03386980-W 20140607/140605235418-ff3d221af708bee4a1d4baa839d9797d (fbodaily.com)
- Source
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