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SAMDAILY.US - ISSUE OF JUNE 18, 2025 SAM #8605
SOLICITATION NOTICE

66 -- Rapid sterility testing system (Milliflex Rapid 2.0)

Notice Date
6/16/2025 7:33:58 AM
 
Notice Type
Solicitation
 
NAICS
334516 — Analytical Laboratory Instrument Manufacturing
 
Contracting Office
FDA OFFICE OF ACQ GRANT SVCS Beltsville MD 20705 USA
 
ZIP Code
20705
 
Solicitation Number
75F40125Q00250
 
Response Due
6/27/2025 9:00:00 AM
 
Archive Date
07/12/2025
 
Point of Contact
Erika Crawford, Phone: 3017960298
 
E-Mail Address
erika.crawford@fda.hhs.gov
(erika.crawford@fda.hhs.gov)
 
Small Business Set-Aside
NONE No Set aside used
 
Description
The Center for Drug Evaluation and Research (CDER), Office of Pharmaceutical Quality Research (OPQR), requires the purchase of rapid microbial limit detection equipment capable of confirming bioburden contamination using membrane filtration with ATP detection. This system will enhance CDER�s current capabilities to test the microbial quality of purified bulk drug substances and final formulated drug products, and support research into the robustness of rapid/alternative microbial detection methods utilized by industry. OPQR currently operates a second-generation Milliflex Oasis filtration pump (model MMSYSTMM2), which requires compatible filter funnels and microbial culture accessories. Therefore, the requested Milliflex Rapid System 2.0 (Millipore Sigma) must include an autospray station and detection tower that are fully compatible with the existing pump and filter membranes.
 
Web Link
SAM.gov Permalink
(https://sam.gov/opp/c18382f119fd4031aeb94b25de847c07/view)
 
Place of Performance
Address: Silver Spring, MD 20993, USA
Zip Code: 20993
Country: USA
 
Record
SN07479386-F 20250618/250616230050 (samdaily.us)
 
Source
SAM.gov Link to This Notice
(may not be valid after Archive Date)

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