Ampoule Leak Test
Sepha has developed an ampoule leak test using vacuum or pressure decay to determine the integrity of glass ampoules.
Ampoules need to be sealed completely, as any crack or defect can contaminate the sterile content inside. To protect medicines and patients, a robust Container Closure Integrity Test solution is key.
The Sepha Multi-Q can be used in combination with vacuum decay or pressure decay test methods and can detect leaks as low as 5µm depending on the content of the ampoule. Ampoules that require extra sensitivity can be tested using the Multi-Q HD, our latest development that can identify leaks as low as 1µm.
Vacuum decay testing is often used for water-based liquid, whereas pressure decay is more suitable for containers filled with toxic product, oil-based liquids, protein/glucose or lyo/powder or other content not suitable for vacuum decay testing.
Both solutions and test methods are non-destructive and provide deterministic, reliable and repeatable results in line with USP 1207 guidelines. The vacuum decay solution utilizes the ASTM F2338-09 standard test method to perform the test. In addition, the Multi-Q and Multi-Q HD can be run in compliance with 21 CFR Part 11.