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

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.