VisionScan and Multi-Q to feature at CPHi & P-MEC India
The Sepha VisionScan and Multi-Q are set to feature at CPHi & P-MEC India from 26 – 28 November 2019. The India Expo Centre in New Delhi will host over 1,500 exhibitors and is expected to see over 43,000 visitors over the three day event. As one of the strongest emerging markets in the global pharma industry, India presents great opportunities for all international pharmaceutical companies to explore and benefit from. CPhI & P-MEC India represents the platform where international and domestic pharma experts meet to do business, network and shape the future of the Indian and South East Asian pharmaceutical industry.
The Sepha VisionScan and Multi-Q will be on display on the Parle stand #9.B02. Both systems offer non-destructive and deterministic leak test solutions for the pharmaceutical packaging industry. Manufacturers of blister packs, induction sealed bottles, sachets, pouches or medical devices are required to demonstrate integrity of their products. The quality of their packaging is key to ensure drug stability, as any defects can affect the shelf life and efficacy of the content. They need to be able to count on the accuracy of their leak test procedures to minimise recalls and reduce the associated costs.
Our leak test systems are specially designed to rapidly test for leaks in a wide variety of pharmaceutical packaging. Unlike the industry standard destructive test methods like Blue Dye Methylene, our testing methods are non-destructive, allowing product that has been tested to be returned to the production line.
Container Closure Integrity Testing
The Sepha Multi-Q offers a non-destructive Container Closure Integrity Testing (CCIT) method in line with ASTM standards to test liquid and lyophilized filled vials, filled bottles, liquid filled ampoules, pre-filled syringes, BFS and other containers and medical devices. The lab-scale unit has a small footprint and offers the flexibility to switch between test methods depending on product and specified test requirements. Using vacuum and pressure decay methods, the system offers a reliable and deterministic quality control solution suitable for a range of products and container types.
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.
- Pressure Decay Bag Tester
Non-destructive leak test solution for empty bags including IV bags, blood bags and catheters. The deterministic, quantitative and calibrated test method can identify gross as well as micron holes.
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.
Read more about the Sepha Multi-Q.
Blister Leak Test
The Sepha VisionScan is an innovative test method that uses imaging technology to provide a deterministic and non-destructive solution to improve the accuracy of blister leak test procedures. Using a combination of differential pressure and imaging technology, the machine can detect leaks, weak seals and channel leaks as low as 7µm. The machine is easy to operate and does not require any additional tooling, making it the perfect solution to test blister packs in different sizes and formats. After placing a blister pack in the test chamber, a pass/fail result will be given within 6 seconds for micron holes and 10 seconds for gross holes.
To see how the Multi-Q and VisionScan can help you improve the accuracy of your leak test procedures and reduce cost, visit us at the Parle stand #9.B02 for a free demo. We look forward to seeing you in New Delhi!