Vial leak test
If you require a vial leak test method to assess container closure of your glass vials, the Sepha Multi-Q or Multi-Q HD could be the right solution for you. The non-destructive devices are ideal for stability testing, clinical trials and in-process quality control testing.
The multi-functional machines 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. The Multi-Q HD has been developed for applications that require higher sensitivity and can test down to 1µm.
- Multi-Q 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.
- Multi-Q 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.
- Multi-Q HD Vacuum decay
A non-destructive, deterministic Container Closure Integrity Testing system developed to identify leaks in parenteral containers down to 1 micron. It utilises vacuum decay according to ASTM F2338-09 standard test method and is in line with new guidelines outlined in USP 1207 preferring deterministic and objective methods that provide reliable and repeatable results. The Multi-Q HD offers a quick and reliable solution for applications that have a lower Maximum Allowable Leakage Limits (MALL) and require a higher level of sensitivity to demonstrate CCI.