Vial leak test
If you require a vial leak test method to assess container closure of your glass vials, the Sepha Multi-Q could be the right solution for you. The non-destructive device is ideal for stability testing, clinical trials and in-process quality control testing.
The multi-functional machine can operate in combination with both vacuum decay and pressure decay test methods, enabling you to test vials containing dry or liquid content including toxic and oil-based liquids.
The Sepha Multi-Q provides a quick test process as leaks and channel leaks as low as 5µm (container type and content dependent) can be identified within 10 seconds.
- Vacuum decay
The vacuum decay method utilizes the FDA approved ASTM F2338-09 standard and is in line with USP 1207 recommendations. Test results are deterministic, eliminating operator subjectivity associated with blue dye tests. The vacuum decay test method can test vials, and other parenterals, containing water-based liquid.
- Pressure decay
The pressure decay method is developed to detect leaks in vials, ampoules, bottles and other containers containing toxic product, oil-based liquid, lyo/powder, glucose/protein, or other content not suitable for vacuum decay testing. The non-destructive technique provides deterministic, reliable and repeatable results in line with USP 1207 guidelines.