SOLICITATION NOTICE
66 -- GE Ready To Process Wave 25 or “equal” - FDA-RFQ-1166563R1
- Notice Date
- 7/29/2016
- 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-1166563R1
- Archive Date
- 8/24/2016
- 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
- Total Small Business
- Description
- The U.S. Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) has a requirement for a GE ready To Process Wave 25 “brand name or equal”. This fully integrated hardware, software, and peripherals wave system will allow continuous bioprocessing and integration downstream to yield continuous production to feed into a final Fast Protein Liquid Chromatography (FPLC) purifier within the lab. Part 1 - Description The U.S. Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER) has a requirement for a GE ready To Process Wave 25 "brand name or equal". This fully integrated hardware, software, and peripherals wave system will allow continuous bioprocessing and integration downstream to yield continuous production to feed into a final Fast Protein Liquid Chromatography (FPLC) purifier within the lab. 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 Part 12 and 13 procedures. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2005-86. 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 a small business set-aside. Part 2 - Supplies or Services and Prices/Costs Purchase Order Type: Firm-Fixed Price Base Year ManufacturerProduct CodeDescriptionPrice GE Healthcare28988000ReadyToProcess WAVE 25 GE Healthcare29044081ReadyToProcess CBCU Full GE Healthcare29032003ReadyToProcess Pump 25 GE Healthcare29044473Tray 20 GE Healthcare29044476Lid 20 GE Healthcare29128116Unicorn Workstation GE Healthcare29115456UNICORN 7 Evaluation Classic GE Healthcare18116852Analysis Software Controller GE HealthcareCB0002L11-33Cellbag, 2L, BC11, pHOPT DOOPT II Screwcap GE HealthcareCB0002L11-34Cellbag, 2L, BC11, pHOPT, DOOPT II Perfusion GE HealthcareCB0010L11-33Cellbag, 10L, BC11, pHOPT DOOPT II Screwcap GE HealthcareCB0010L11-34Cellbag, 10L, BC11, pHOPT,DOOPT II Perfusion GE HealthcareCB0020L11-33Cellbag, 20L, BC11, pHOPTDOOPT II Screwcap GE HealthcareCB0020L11-34Cellbag, 20L, BC11, pHOPT,DOOPT II Perfusion Installation and onsite training Shipping Total Firm Fixed Price Option Years Option YearDescriptionPrice 1Service Agreement 2Service Agreement 3Service Agreement Total Firm Fixed Price The total price for the base and three option years is $____________. Part 3 - Description/Specifications 3.1 Background The Office of Biotechnology Products currently performs applied regulatory research on bio manufacturing process development, tying together upstream processes to downstream purification and formulation. The lab currently operates lab scale bioreactors to understand the effects of manufacturing changes during bioprocessing on product quality. The division currently requires the ability to produce larger quantities of material but must avoid traditional centrifugal based clarification procedures due to facility constraints. Additionally, research aims are focused on expanding continuous bio manufacturing studies, and the effects on product quality versus a standard fed batch operation. 3.2 Statement of Work/Salient Characteristics All equipment shall be newly manufactured and not used for demonstration purposes or refurbished. The Cell Culture Unit Operation shall possess the following: 1.System shall include all hardware to run a single-use mammalian cell culture with rocking as the mechanism for mixing and aeration. 2.Capable of operating volumes between 0.3 and 25L, with the ability to run parallel cultures on the same platform while allowing independent control of each culture. 3.Rocking platform with integrated load cell, temperature sensor, integrated heating mechanism to maintain culture temperature, and adjustable rocking speed, angle and motion to regulate gas transfer and culture mixing. •Due to space constraints, the rocking platform shall be no larger than 160 in. x 85 in. x 225 in. (WxHxD) and shall weigh less than 55 pounds. •Rocking angle shall be adjustable to at least between 5° and 10° with speed control in the range of 1 and 50 rpm. •Temperature control shall be able to accommodate a 37°C culture +/- 3°C. 4.Control unit shall include a mass flow controller, automated gas mixing based on internal algorithms, pH unit compatible with optical pH patches, Dissolved Oxygen unit compatible with optical DO patches, and the ability to control CO2, O2, pH, and DO. 5.Gas flow shall be adjustably supplied in the range of 100 - 1000 mL/min. 6.Dissolved Oxygen (DO) shall be controllable between 0% - 50% with less than 0.75% variation from the setpoint. 7.pH shall maintain a 7.0 pH (+/- 0.05) setpoint 8.A pump with two peristaltic pump heads for feed and base addition shall be able to be integrated in to the main bioreactor control unit for automated pH and perfusion control. Pump shall be capable of flow rates between 0.1 and 100 mL/min. 9.External controller shall be provided to use analysis software and any software modification packages. The Software shall possess the following: •UNICORN 7 software shall be used to control the unit in order to interface with existing purification capabilities of the division. Delivery, Installation, Training and Warranty: •Installation shall include of the installation of the system and all components, as well as software installation. •Shall include training at the FDA site for a least 2 days and for at least 5 FDA scientists as well as training manuals and literature in electronic or hard copy. •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. 3.3 Optional Service Agreement The FDA shall have a unilateral right to exercise optional periods to continue the service agreement described below: The offerors pricing for optional service agreement shall include coverage of labor, parts and travel expenses. Parts- The service plan will use Original Equipment Manufacturer (OEM) certified parts. Services On-Site- The contractor will initiate corrective maintenance/repairs within 48 hours from the service call. The repairs will be completed within 72 hours from the on-site arrival of the technician/service engineer. There will be no limit to the number of on-site repair service visits. The service shall be delivered by an authorized OEM service provider. Services Off-Site- Technical support and troubleshooting assistance will be provided by the contractor via phone, email, or live-chat interface within 1 hour of initial contact. 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 Ave Bldg 72 RM 2232 Silver Spring, MD 20993 ATTN: TBD The system shall be delivered to the address above for assembly. 4.2 Period of Performance The equipment shall be delivered by September 1, 2016. The warranty shall start when equipment is installed and accepted by FDA and be in effect for one year. Optional Periods DeliverablePeriod of Performance Option Period 1 -Service AgreementTo begin 1st year following receipt of equipment Option Period 2 -Service AgreementTo begin 2nd year following receipt of equipment Option Period 3 -Service AgreementTo begin 3rd year following receipt of equipment Part 5 -Contract Administration 5.1 Representative's The Contracting Officer's Representative (COR) will perform inspection and acceptance of materials and services to be provided. For the purpose of this PART, (COR TBD) is the authorized representative of the Contracting Officer. The COR is responsible for the following as required by this order: (1) monitoring the Contractor's technical progress, including the surveillance and assessment of performance and recommending to the Contracting Officer changes in requirements; (2) interpreting the Statement of Work and any other technical performance requirements; (3) performing technical evaluations; (4) performing technical inspections and acceptances; and (5) assisting in the resolution of technical problems encountered during performance. The Contracting Officer is the only person with authority to act as an agent of the Government under this order. Only the Contracting Officer has authority to: direct or negotiate any changes in the order, including modifying or extending the period of performance, changing the delivery schedule, authorizing reimbursement to the Contractor for any costs incurred during the performance of this order, or otherwise change any terms and conditions of this order. The contact information for the Contracting Officer is the following: Sean Wybenga U.S. Food and Drug Administration Office of Acquisitions and Grants Services 5630 Fishers Lane Rockville, MD 20857 Sean.Wybenga@fda.hhs.gov; (240) 402-7629 The contact information for the Contract Specialist is the following: Lisa Yaw U.S. Food and Drug Administration Office of Acquisitions and Grants Services 5630 Fishers Lane Rockville, MD 20857 Lisa.Yaw@fda.hhs.gov; (240) 402-4018 The contact information for the Contractor is the following: (TBD)
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/FDA-RFQ-1166563R1/listing.html)
- Place of Performance
- Address: White Oak Campus, 10903 New Hampshire Ave, Bldg 72 RM 2232, Silver Spring, Maryland, 20993, United States
- Zip Code: 20993
- Zip Code: 20993
- Record
- SN04201440-W 20160731/160729234407-2f029479d84ce8227d65712ec09e4b8b (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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