SOLICITATION NOTICE
66 -- Microfeeder - FDA-RFQ-1179272
- Notice Date
- 2/27/2017
- Notice Type
- Combined Synopsis/Solicitation
- 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-RFQ-1179272
- Archive Date
- 3/24/2017
- 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
- Microfeeder for Pharmaceutical Ingredients 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. The Microfeeder shall meet the following specifications: • 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
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/FDA-RFQ-1179272 /listing.html)
- Place of Performance
- Address: Food and Drug Administration, White Oak Campus, 10903 New Hampshire Avenue, WO Building 62 Loading Dock, Silver Spring, Maryland, 20993, United States
- Zip Code: 20993
- Zip Code: 20993
- Record
- SN04415459-W 20170301/170227234423-69aeca1497b3f05a291a74262a3a3cea (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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