Sources Sought Notice: Drop Shape Analysis Instrument and Accessories
Sources Sought Notice: Drop Shape Analysis Instrument and Accessories
MARKET RESEARCH PURPOSES ONLY
NOT A REQUEST FOR PROPOSAL OR SOLICITATION
The U.S. Food and Drug Administration (FDA), Office of Acquisitions and Grants Services (OAGS) is conducting market research to support the Center for Drug Evaluation and Research’s (CDER). CDER’s The Division of Product Quality Research (DPQR) is requesting a bench-top drop shape analyzer, to facilitate research and fundamental characterization of pharmaceutical materials and products, including drug substances, excipients, emulsions, suspension, granules and polymer solutions. Surface and interfacial tension, contact angles and surface free energy are key attributes of materials that could impact the performance of a drug product. Traditional measurement techniques are largely based on manual operations and sophisticated calculations which are often time consuming, low reproducible and may require large amount of samples. The requested equipment combines automatic, standardized dosing system and automatic analysis system, enabling surface tension/energy, contact angle, and interfacial rheology to be determined.
This is a Sources Sought notice to determine the availability of Small Businesses capable of supplying the required supply item/services. This notice is for planning purposes only, and does not constitute an invitation for Bids, Request for Proposal or Request for Quotation or an indication the Government will 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.
Capabilities Required:
The FDA is seeking sources of a bench-top drop shape analyzer, to be determined capable of proving this instrument interested vendors shall be able to provide a drop shape analysis instrument meeting or exceeding the following salient characteristics:
· The measurement principle of the instrument should be based on image analysis using sessile drop and pendant drop
· It should provide measurement of ALL of the following: static and dynamic contact angles, surface tension (liquid in air), interfacial tension (liquid in liquid), surface free energy and the rheological properties at the interface
· High resolution, high speed camera (CMOS sensor) with at least 200 fps at 1200×800 pixel (up to 2000 fps at lower resolution)with at least 5x optical magnification (motorized and fully automatic)
· LED illumination with built-in IR filter to reduce optical disturbance
· The sample stage should be motorized that allows for x-y shift and tilting (0 to 90°)
· The sample stage should be software controlled
· Accurate dosing unit capable of simultaneous or sequential dosing two type of liquids, with resolution of at least 0.1 µL for each liquid
· The measuring range of surface and interfacial tension of liquids should cover the range of 0.01 to 1000 mN/m with a resolution of at least 0.01 mN/m
· The measuring range of contact angel should cover 1-180° with resolution of 0.1°
· The system should be capable of interfacial rheological measurement based on oscillation frequency of pendent drops
· Sample temperature measurement should cover the range of -40 to 350°C with resolution of 0.1°C
· Operation environment temperature should cover the ranger of 15 to 35°C
· Small foot-print, no more than 600×400×500 mm (W×D×H)
· The item should include computer/monitor with pre-installed software to perform measurement and analysis of all aforementioned properties; the item should also include OFFICE suits for data analysis
· The item should include all necessary accessories to conduct basic sample measurement and analysis, including but not limit to syringes, connectors, needles.
In addition, the respondent vendors shall be required to have the capability to furnish the following accessories/services:
o System crating, shipping, and delivery.
o Full system software and peripheral installation.
o On-site hardware and software training.
Capability Statements:
Responses to this sources sought shall unequivocally demonstrate the respondent’s capabilities to provide the instrument, accessories, and services described above. Though the target audience is small business, all interested parties may respond. At a minimum, responses shall include the following:
1. Business name and bio, 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 again if responding to provide a service offered by another firm.
2. Past Performance information shall include date of services, description, dollar value, client name,
3. Client address, client 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 company (to include DUNS number and size status) if not the respondent.
4. Descriptive literature, brochures, marketing material, etc. detailing the nature of services the responding firm is regularly engaged in providing.
5. If applicable, identification of the firm's GSA Schedule contract(s) by Schedule number and Schedule Item Numbers (SIN)s that are applicable to this potential requirement are also requested. If a large business, clarify if subcontracting opportunities exist for small business concerns. The Government is not responsible for locating or securing any information, not identified in the response.
Response Instructions:
Interested parties shall respond with capability statements in person, by e-mail, fax, mail or other delivery method before 3:00 PM Eastern Time on March 22nd, 2018 to Christopher.mcgucken@fda.hhs.gov.
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).
Christopher R. McGucken, Contracting Officer, Phone (240) 402-7599, Email christopher.mcgucken@fda.hhs.gov
