MARKET RESEARCH PURPOSES ONLY
NOT A REQUEST FOR PROPOSAL OR SOLICITATION
The U.S. Food and Drug Administration (FDA), is conducting market research to support the Center for Drug Evaluation and Research (CDER) requirement for an Oscillatory Baffled Crystallizer system.

This is a Sources Sought Notice to determine the availability and capability of Small Business Manufacturers or Small Businesses capable of supplying a U.S. made product of a small business manufacturer or producer. This notice is for planning purposes only, and does not constitute an Invitation for Bids, Request for Proposals or Request for Quotation, or an indication the Government will contract for the items contained herein. This notice is not to be construed as a commitment on the part of the Government to award a contract, nor does the Government intend to pay for any information submitted as a result of this notice. Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible.

The appropriate NAICS code for this acquisition is 334516- Analytical Laboratory Instrument Manufacturing; Small Business Size Standard is 1,000 employees.

Statement of Work (SOW)

Statement of Need

CDER Office of Pharmaceutical Quality (OPQ) requires an Oscillatory Baffled Crystallizer system to study the continuous manufacturing of active pharmaceutical ingredients in a plug flow type of system. A continuous flow stirred tank system was developed and studied before. A second option for continuous crystallization process is plug flow which shows completely different fluid and crystallization dynamics. This instrument will support CDER/OPQ continuous manufacturing initiatives.  

General Requirement

1. The components and/or equipment shall be a newly manufactured, not used and refurbished, or previously used for demonstration.
2. The instrument shall be warranted for parts and labor from date of installation acceptance. All warranty work shall be performed on-site at CDER, i.e., returning the equipment to the manufacturer is unacceptable.
3. The system shall be delivered with all components, accessories, start-up supplies required for installation and start-up., i.e., a turn-key solution.

Technical Requirement

At a minimum, the system shall meet following requirement:

1. The system shall for the implementation of sensors such as thermocouples and online particle size measurement in order to measure process variables and crystal attributes.
2. The system shall allow for lab scale experiments with residence time of 15 to 30 minutes is necessary for the development and understanding of the plug flow continuous crystallization process.
3. The system shall be compact.
4. The system shall be able to provide good mixing via oscillations.
5. The system shall allow for manipulation of crystallizer length (for example, the number of segments can be changed).
6. The system shall allow for temperature control per segment using external heating or cooling source. Temperature range shall be at least be 5 - 90 degree C.
7. The system shall have safety cautions such as pressure sensor to ensure safe shutdown in case of overpressure.
8. The system shall be compatible with most organic solvents, such as ethanol.
9. The oscillations shall allow for control of amplitude (at least 0 to 65mm) and frequency (at least 0 to 3.0Hz).
10. 4. The Contractor shall provide telephone/e-mail support for questions regarding system installation, operation, familiarization and training.
11. The system shall be warranted for a minimum of 12 months.
12. The system shall be able to fit into a standard fume hood, 62"x24"x48" (width, depth, height), and be easy to operate within the hood.

FOB Point Destination: Delivery/Installation is within ninety (90) calendar days after receipt of contract award.

Delivery Address:
Food and Drug Administration
White Oak Campus
Center for Drug Evaluation and Research
10903 New Hampshire Avenue
Building 62 Loading Dock
Silver Spring, MD 20993
POC (will be provided at time of award)

The respondent to this source sough shall furnish sufficient technical information necessary for the Government to conclusively determine its capability to provide products/services and components meeting the technical requirements identified above. Though the target audience is small business manufacturers or small businesses capable of supplying U.S. made system of another small business manufacturer or producer, all interested parties may respond. At a minimum, responses shall include the following: Business name, 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 if responding to provide a product manufactured by another firm); Sufficient descriptive literature that unequivocally demonstrates that offered products and services meet or exceed above specifications. All descriptive material necessary for the government to determine whether the service/product offered meets the technical requirements including: technical specifications, descriptive material, literature, brochures and other information, which demonstrates the capabilities of the contractor to meet the requirement. Three (3) years of past performance information for the manufacture and/or sale of same or substantially similar items to include date of sale, description, dollar value, client name, client address, client point of 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. If applicable, identification of the firm's GSA Schedule contract(s) by Schedule number and SINs that are applicable to this potential requirement.

The government is not responsible for locating or securing any information, not identified in the response.

Interested parties shall respond with capability statements which are due in person, by postal mail or email to the point of contact listed below on or before June 29, 2017, 12:00 PM (Central Time in Jefferson, Arkansas) at the FDA/OO/OFBA/OAGS/DAP, Field Operations Branch, Attn: Regina Williams, 3900 NCTR Road, HFT-320, Jefferson, AR 72079-9502 or email [email protected]. Reference FDA1184873.

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 Federal Business Opportunities. 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)

Bid Protests Not Available