Tangential Flow Filtration System
Waiver type - Procurement: Nonavailability
Agency: CENTERS FOR DISEASE CONTROL AND PREVENTION (7523) • Product Service Code (PSC) : 6640 | Last Modified: 08/26/2024
Procurement Summary
This is a sole source requirement for one (1) Tangential Flow Filtration (TFF) system, along with training and install qualification and operation qualification (IQOQ). The requirement aims to identify a small machine that has the ability to purify and concentrate proteins, viruses, and RNA to meet vaccine development needs and identify a supplier that can provide quality products with reasonable size and reasonable price to serve the purpose.
Waiver Rationale Summary
Formulatrix’s is the OEM of the uPUSLE system, the smallest of the benchtop TFF systems being considered, at only 10.4” x 13.5” (W x D). It’s uniqueness will improve laboratory efficiency, as less time is needed to clean the instrument between runs. Furthermore, the uPULSE system allows is complaint with 21CFR58.63 and 21CFR58.81. The system has disposable flow paths, which are especially useful when switching between the two main use cases, i.e., concentrating virus particles before concentrating RNA. Reducing contamination between these different sample types would be a key QC component during the use of such an instrument.
No
No
Consistent with Policy
LABORATORY EQUIPMENT AND SUPPLIES
334516 - Analytical Laboratory Instrument Manufacturing
08/12/2024
N/A
N/A
Pre-solicitation
0 - 6 months
Individual Waiver
CENTERS FOR DISEASE CONTROL AND PREVENTION