The Sepha Multi-Q is a non-destructive, deterministic and multi-functional Container Closure Integrity Testing system designed to detect leaks in non-porous, rigid or flexible packaging.
The lab-scale unit has a small footprint and offers the flexibility to test different container types by use of interchangeable tooling and test methods including vacuum and pressure decay. The tooling can be easily changed and the relevant recipes for the selected attachment will be available to start testing immediately.
The Sepha Multi-Q offers non-destructive and deterministic CCIT methods in line with ASTM and USP 1207 guidelines to test liquid and lyophilized filled vials, filled bottles, liquid filled ampoules, pre-filled syringes, BFS and other containers and medical devices. Using vacuum and pressure decay methods, the system offers a reliable and deterministic quality control solution suitable for different container types and content.
Testing methods that are compatible with the Multi-Q are:
• Vacuum Decay
Utilizes the ASTM F2338-09 test method to test vials, ampoules, bottles, pre-filled syringes, blow filled seals, medical devices and trays. The non-destructive, deterministic leak test device can identify leaks and channel leaks as low as 5µm (dependent on container type and content) and gives a pass/fail result in as little as 10 seconds.
Parenteral applications that have a lower Maximum Allowable Leakage Limit (MALL) often require a higher level of sensitivity. The Multi-Q HD has been developed to reach this sensitivity enabling ultra-sensitive detection of micron defects as low as 1µm (dependent on container type and content).