SOURCES SOUGHT
66 -- Micro-feeder to Support Pharmaceutical Continuous Manufacturing Processes - FDA-SS-1179272
- Notice Date
- 2/10/2017
- Notice Type
- Sources Sought
- NAICS
- 334513
— Instruments and Related Products Manufacturing for Measuring, Displaying, and Controlling Industrial Process Variables
- 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-SS-1179272
- Archive Date
- 3/10/2017
- 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
- This is a Small Business Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding: (1) the availability and capability of qualified small business sources; (2) whether they are small businesses, HUBZone small businesses, service-disabled, veteran-owned small businesses, 8(a) small businesses, veteran-owned small businesses, woman-owned small businesses, or small disadvantaged businesses; and (3) their size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition, which is 334513, Instruments and Related Products Manufacturing for Measuring Displaying, and Controlling Industrial Process Variables. The associated small business standard is 750 employees. Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. An organization that is not considered a small business under the applicable NAICS code should not submit a response to this notice. 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 it submits. 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. 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). Background As one of the state-of-the-art manufacturing approaches listed in the FDA's strategic plan for advancing regulatory science (2011), continuous manufacturing has been discussed in recent pharmaceutical conferences and holds great promise for the future of pharmaceutical manufacturing. In April 2016, pharmaceutical advanced manufacturing has been identified as the nation's priority technology areas by the White House. Given the rapid development of continuous manufacturing in the pharmaceutical industry, there is an urgent need to establish a laboratory-scale continuous manufacturing line in DPQR to upgrade its research infrastructure to meet the advanced manufacturing regulatory research need. Since feeding is the first step for any continuous manufacturing processes, we propose to purchase a feeding system that enables to feed various types of pharmaceutical ingredients. A micro feeder is a necessary component to establish such a feeding system, especially for feeding of lubricant, or for low-drug content scenarios. The established system will enable DPQRs continuous manufacturing research program to showcase the state-of-the-art manufacturing research infrastructure for integrated continuous manufacturing and real-time process monitoring and control. Scope The vendor shall deliver a Micro-feeder which meets the following specification: • product contact metal parts are in stainless steel with pharmaceutical grade metal finish, nonmetal product contact parts are made of FDA compliant materials ((http://www.fda.gov/Food/IngredientsPackagingLabeling/PackagingFCS/RegulatoryStatusFoodContactMaterial/ucm120771.htm) • hopper volume should be no more than 2L • capable of feeding with the rate between 0.07-4 hr. • twin-screw interchangeable feeding tools that are capable of gravimetric feeding free flowing to very poorly flowing powders • interchangeable twin screws with different sizes (for example 12mm and 16mm) • compact horizontal design • easy access to parts for cleaning • equipped with control system to enable operator control at the interface. • includes control systems that assure feeding accuracy during re-fill with a stabilization time of not more than 1 minute. • includes operational software for download on customer supplied PC • enclosed weight sensor and drive motor with high torque for handling difficult materials, such as fluffy, cohesive, and dense materials • must have polish level II coating on hopper and feeder Also Includes: • System crating, shipping, and delivery • Full system software and peripheral installation and verification of performance • The instrument must be a newly manufactured unit, not used and refurbished or previously used for demonstration. • The entire system must be warranted for parts and labor for 12 months from the date of installation. Software updates to be furnished at no additional cost during the warranty period. Technical support to be furnished at no additional cost during the warranty period. • Onsite training on the use and features of this instrument is required. CAPABILITY STATEMENT/INFORMATION SOUGHT The FDA is requesting interested, qualified small businesses to provide a capability statement showing their ability and willingness to complete this requirement. The capability statement will be sent electronically to Lisa Yaw at Lisa.Yaw@fda.hhs.gov in a commonly used format, such as Microsoft Word or pdf. This capability statement will be no more than five pages, excluding a cover page and table of contents, and will include examples of successfully completing relevant similar work, including a description of the similar work and client contact information. The FDA will be determining capability based on the ability to perform the tasks delineated above. Interested eligible small businesses will also include company information to determine eligibility, including their contact information, Dun and Bradstreet (DUNS) number and size and business type (e.g. 8(a), HUBZone, etc.,) based on the applicable NAICS code for the proposed acquisition, Instruments and Related Products Manufacturing for Measuring Displaying, and Controlling Industrial Process Variables. The associated small business standard is 750 employees. Entities have until 2 pm ET, Thursday, February 23, 2017 to respond to the FDA.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/FDA-SS-1179272/listing.html)
- Place of Performance
- Address: Food and Drug Administration, White Oak Campus, 10903 New Hampshire Avenue, Silver Spring, Maryland, 20993, United States
- Zip Code: 20993
- Zip Code: 20993
- Record
- SN04399293-W 20170212/170210234629-5020f95a17add106ad1adf7613e2d59e (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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