Vacuum Decay Leak Test Method

Vacuum Decay Leak Test Method - Multi-Q HD

The Sepha Multi-Q HD is a non-destructive, deterministic and reliable vacuum decay leak test method developed to detect leaks down to 1 micron in parenteral containers.

The system utilises vacuum decay according to ASTM F2338-09 standard test method, the FDA recognized consensus for non-destructive detection of leaks in packages by vacuum decay. The method is in line with new guidelines outlined in USP 1207 preferring deterministic and objective methods that provide reliable and repeatable results.

Key features & Benefits:

• Vacuum Decay leak test method to identify leaks and micro holes as low as 1µm (dependent on container type and content)
• Non-destructive and deterministic test method
• Ideal for testing vials, ampoules, bottles, pre-filled syringes and BFS strips containing water-based liquid
• Rapid test time as low as 10 seconds
• Reliable and repeatable results
• Utilizes the ASTM F2338-09 test method to perform the leak test
• In line with USP 1207 guidance
• 21 CFR Part 11 compliant

Containers that cannot be tested using a vacuum decay test, including toxic product or oil-based liquids, can be tested using the Pressure Decay method, also compatible with the Sepha Multi-Q.

Download the Sepha Multi-Q brochure by completing the form on the right to learn more about the versatile Multi-Q leak test system and how you could improve your package assurance process.