# CDER-2024-123188 DM-Vacuum Pressure Decay Leak Test

Canonical: https://abierto.us/opportunities/fdarfqcder2024123188dm

- Solicitation number: FDA-RFQ-CDER-2024-123188-DM
- Notice type: Combined synopsis and solicitation
- Status: Closed. Deadline was May 25, 2024 at 12:00 PM EDT
- Department: Department of Health and Human Services
- Agency: Food and Drug Administration
- Contracting office: FDA Office of Acq Grant SVCS (75F401)
- NAICS: 334516 Analytical Laboratory Instrument Manufacturing
- Product or service code: 6640 Laboratory Equipment and Supplies
- Place of performance: Silver Spring, Maryland
- County: Montgomery County (FIPS 24031). https://abierto.us/counties/montgomery-county-md-24031
- City: Silver Spring. https://abierto.us/cities/silver-spring-md-2472450
- First posted: May 7, 2024
- Last posted: May 7, 2024
- SAM.gov: https://sam.gov/workspace/contract/opp/f1224e23043549ac93493f7a775424a7/view

## Description

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.

## Publications

- May 7, 2024: Combined synopsis and solicitation, due May 25, 2024 at 12:00 PM EDT. Notice f1224e23043549ac93493f7a775424a7. https://sam.gov/workspace/contract/opp/f1224e23043549ac93493f7a775424a7/view

## Points of contact

- Emmanuel T. Mbah, Emmanuel.mbah@fda.hhs.gov, 2404027598

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Source: SAM.gov Contract Opportunities bulk extract. Confirm deadlines on SAM.gov before responding. Cite https://abierto.us/opportunities/fdarfqcder2024123188dm.