Sepha will be exhibiting at Medical Technology Ireland this September, demonstrating its newest container closure integrity testing (CCIT) and leak test solution called the Multi-Q on stand 106.
The show that is known for showcasing innovative medical technology products and solutions for the Irish medical device design and manufacturing industry will return to Galway Racecourse from 25 – 26 September 2019.
The Sepha Multi-Q is a multi-functional CCIT and leak test system that has been developed to work in combination with different test methods. Depending on the type and content of the packaging, the machine can utilise vacuum decay technology, pressure decay technology and a flexible membrane to test the integrity of a wide variety of packaging, including vials, ampoules, pre-filled syringes, blow filled seals, bottles, sachets, bags, medical devices, trays and other flexible and rigid packaging.
The Sepha Multi-Q is compatible with:
- Vacuum decay – The non-destructive, deterministic and quantitative vacuum decay technology utilises the ASTM F2338-09 (2013), US Food and Drug Administration (FDA) approved 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 and gives a pass/fail result in ten seconds
- Pressure decay – The non-destructive, reliable and repeatable pressure decay test method is ideal for testing the integrity of lyophilised and liquid filled vials, ampoules, bottles and other containers. The device shows a pass/fail result in ten seconds and can identify leaks and channel leaks as low as 5µm
- Flexible membrane – The non-destructive, tool-less leak detection device is designed to leak test flexible or semi-flexible packaging. Using hybrid membrane technology, the flexible head utilizes the ASTM F2338-09(2013), FDA approved vacuum decay test method to perform the leak test. Ideal for testing gross or micron holes in pouches, sachets and bags that contain tablets, capsules, powders or devices
- Vacuum decay bag tester – The non-destructive, deterministic, quantitative and calibrated leak test method has been developed to leak test empty plastic bags including intravenous (IV), catheter and blood bags. It can detect micron as well as gross holes
- Ramp to event – Destructive, deterministic, quantitative test method using pressure/vacuum to ramp to an event. This method is used for component testing to detect weak welds, seals
- Ramp to proof pressure – Non-destructive, deterministic, quantitative test method using pressure/vacuum to ramp to a target pressure
- Occlusion – Non-destructive, deterministic, quantitative test method using pressure drop/time. Typically used to test parts that must remain open to function correctly.
The Sepha Multi-Q includes software developed for manufacturers that need to comply with FDA 21 CFR Part 11. The software enables safe interaction between the machine, data reports and audit trails and protects reports from being edited or deleted.
To see a demo of the Sepha Multi-Q or discuss any of our other solutions including small blister packaging machines or deblistering solutions, visit us at Medical Technology Ireland, stand 106 on level 1.
The company looks forward to seeing you in Galway.