Brand Name or Equal Flownamics 4800 Seg-Flow Sampling System

Part 1 - Description
The FDA has a requirement for a Flownamics Seg-Flow Sampling System and accessories or equal with individual control of each vessel to monitor critical parameters during protein production.

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 Parts 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 full and open competition.

Part 2 - Supplies or Services and Prices/Costs

Purchase Order Type: Firm-Fixed Price
Base Year
Manufacturer Product Code Description Quantity Price
Flownamics S-4800 Flownamics Seg-Flow Sampling System and Accessories (Brand Name or Equal)
Shipping
Installation and training
One (1) year warranty on parts and labor
Total Firm-Fixed Price

Option Years
Option Year Description Price
1 Service Agreement
2 Service Agreement
3 Service Agreement
4 Service Agreement
Total Firm Fixed Price

The total price for the base and four option years is $____________.
Part 3 - Description/Specifications

3.1 Background
CDER/DBRR has a requirement for an integrated 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. This instrument will be used for the collection of protein products from cell culture lines in a parallel bioreactor system. The need to characterize the protein production process and to understand critical variables and utilize PAT and QbD techniques is mission critical.

3.2 Salient Characteristics

The contractor shall provide a 4800Seg-Flow Sampling System or equal which includes the following characteristics:

A BENCHTOP instrument shall perform all functions of sample acquisition, transfer, assay and/or sample storage without contamination of the bioreactor. The features of the instrument shall include:

• A parallel system capable of sampling from at least 6 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). This can be a system with a supplemental module to expand bioreactor sampling capabilities.

• Feed pumps to enable feedback loops to the individual bioreactors and any cables required to integrate in to the system.

• Ability to develop a customized feed strategy based on the current cell line capabilities of OBP within the parameters of the autosampling/feedback system.

• Fraction collection device shall be capable of storing a range of vial sizes from 2 mL HPLC vials, to 15/50 mL sample collection tubes. This fraction collection device shall have the option of chilling sample vials and shall include all required consumables necessary for initial setup and operation.

• 0.22µm ceramic membranes compatible with FISP probes to draw cell free samples from the bioreactors.

• Utilize a sanitary sampling interface, located near the bioreactors to clean the sample transfer lines and valves in the module. 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 shall be in series with at least one drain valve, and shall 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 HPLCs and UPLCs.

• 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 Sartorius MFCS, Waters Acquity UHPLC, and Agilent HPLC systems, through OPC control to allow automated sampling and the creation of a feedback loop to incorporate 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 an Agilent high performance liquid chromatography (HPLC) system with in line filtration of cells prior to sample delivery and OPC feedback of the values.

• Shipping, delivery, setup, and installation of hardware and software, interfacing, and training for FDA scientists.

• Provide all necessary OPC licenses to run the system as an OPC Server, and necessary coding to control third party instruments to allow automated operation.

• All labor, parts, and travel expenses for a one year warranty period of system and components.

3.3 Optional Service/Maintenance Agreement

The FDA shall have a unilateral right to exercise optional periods to continue the maintenance work described below:

The offerors pricing for optional service agreement shall include coverage of labor, parts and travel expenses.

Parts- The service plan will use all 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 must 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 Scott Lute , see below.

Location and Point of Contact:
Food and Drug Administration
White Oak Campus
10903 New Hampshire Avenue
Silver Spring, MD 20993

ATTN: TBD
TBD@fda.hhs.gov

The instrument will be delivered to the WO Bldg 52/72 Loading Dock, and transported to WO bldg 72 room 2232 for bench top assembly.

4.2 Period of Performance

The equipment shall be delivered by June 1, 2016. The warranty shall start when equipment is installed and accepted by FDA and be in effect for one year.

Optional Periods

Deliverable Period of Performance
Option Period 1 -Service Agreement To begin 1st year following receipt of equipment
Option Period 2 -Service Agreement To begin 2nd year following receipt of equipment
Option Period 3 -Service Agreement To begin 3rd year following receipt of equipment
Option Period 4 -Service Agreement To begin 4th 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 - TBD@fda.hhs.gov) 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