CDER-2024-123188 DM-Vacuum Pressure Decay Leak Test
Closed Solicitation Posted
Not the latest version. See the latest pre-solicitation from .
- Solicitation number
- FDA-RFQ-CDER-2024-123188-DM
- Agency
-
FDA Office of Acquisition and Grant Services
Food and Drug Administration, Department of Health and Human Services
- Responses due
- Set-aside
- No set-aside
Opportunity facts
- NAICS code
- 334516 Analytical Laboratory Instrument Manufacturing
- PSC
- 6640 Laboratory Equipment And Supplies
- Place of performance
- Silver Spring, Maryland 20993, United States
- Points of contact
Notice details come from SAM.gov. Updated .
About this opportunity
The U.S. Food & Drug Administration (FDA) Office of Acquisition and Grants Services (OAGS) is seeking to procure a vacuum pressure decay leak test instrument to ensure the container closure integrity of parenteral pharmaceutical products. The key requirements include the tester being non-invasive, quantitative, and capable of testing a variety of packaging formats from 0.2 milliliters to 1 liter. It must be compatible with different dosage forms, sensitive enough to detect 5 micron leaks or smaller, and produce objective data. The procurement will be a firm fixed-price purchase order, with the NAICS code for Analytical Laboratory Instrument Manufacturing. Offers must be submitted by May 25, 2024, with all items or none, and the vendor must meet all technical specifications to be considered responsive.
This procurement is not set-aside for any particular business category. The place of performance is Silver Spring, MD 20993, USA. The government has not provided any information about potential incumbents or current contractors, award values, or budget ranges. The required quantity is not specified.
Notice text
The U. S. Food & Drug Administration, (FDA) Office of Acquisition and Grants Services (OAGS) seek to procure: CDER-2024-123188 DM - Vacuum Pressure Decay Leak Test. Container closure integrity of parenteral products is essential to protect the product through the entire lifecycle until patient delivery. Early detection of leaks in the container closure systems of pharmaceuticals is critical in preserving the quality of pharmaceutical throughout their shelf life, reduce the risk of contamination and ensure patient safety. To this end, the Division of Product Quality Research is seeking to purchase a reliable sensitive deterministic CCIT tester based on the vacuum & pressure decay principles. The leak detection should be based on a physicochemical technology that can be readily controlled, monitored, and yields objective quantitative data. The instrument shall be flexible and compatible with multiple formats or packing systems.
Files
| File | Type | Posted |
|---|---|---|
| FDA-RFQ-CDER-2024-123188 DM - Vacuum Pressure Decay Leak TestS.docx | DOCX document |
Notice history
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