Discover the Sepha Multi-Q at ProPak Asia
If you are still using Blue Dye Methylene to leak test your pharmaceutical packs, you are throwing away valuable product whether the pack fails or not. The Sepha Multi-Q is a non-destructive, 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 utilize 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 utilizes the ASTM F2338-09 (2013), 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 10 seconds.
- Pressure Decay
The non-destructive, reliable and repeatable pressure decay test method is ideal for testing the integrity of lyophilized and liquid filled vials, ampoules, bottles and other containers. The device shows a pass/fail result in 10 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.
The machine 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.
The non-destructive and deterministic test methods provide quick, reliable and repeatable results enabling you to improve the accuracy of your leak detection procedures and reduce cost as the methods prevent the packaging from being damaged.
Also on show will be the Sepha VisionScan a small, non-destructive, tool-less leak test solution for pharmaceutical blister packs. This machine uses a combination of imaging technology and differential pressure and can detect leaks in individual blister packs down to 7 micron (pack dependent). It offers pharmaceutical manufacturers a cost saving alternative to methylene blue dye testing as the blister packs aren’t destroyed during testing enabling product to be returned to the production line.
To see a demo of the Sepha Multi-Q or the Sepha VisionScan, visit us at the KTBEL booth #AG39 in Hall 98. Or if you’d like to discuss any of your leak test requirements, get in touch with Business Development Manager David Foster who will be at the show as well.
We look forward to seeing you in Bangkok!