Rapid sterility testing system (Milliflex Rapid 2.0)
| Location: | Maryland |
|---|---|
| Posted: | Jun 16, 2025 |
| Due: | Jun 27, 2025 |
| Agency: | HEALTH AND HUMAN SERVICES, DEPARTMENT OF |
| Type of Government: | Federal |
| Category: |
|
| Solicitation No: | 75F40125Q00250 |
| Publication URL: | To access bid details, please log in. |
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- Contract Opportunity Type: Solicitation (Original)
- Original Published Date: Jun 16, 2025 10:33 am EDT
- Original Date Offers Due: Jun 27, 2025 12:00 pm EDT
- Inactive Policy: 15 days after date offers due
- Original Inactive Date: Jul 12, 2025
-
Initiative:
- None
- Original Set Aside: No Set aside used
- Product Service Code: 6640 - LABORATORY EQUIPMENT AND SUPPLIES
-
NAICS Code:
- 334516 - Analytical Laboratory Instrument Manufacturing
-
Place of Performance:
Silver Spring , MD 20993USA
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.
- 4041 Powder Mill Road 4th Floor
- Beltsville , MD 20705
- USA
- Erika Crawford
- erika.crawford@fda.hhs.gov
- Phone Number 3017960298
- Jun 16, 2025 10:33 am EDTSolicitation (Original)
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