Container Closure Integrity Testing
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 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.
- Pressure Decay
Non-destructive, reliable and repeatable test method, ideal for testing the integrity of lyophilized and liquid filled vials, ampoules, bottles and other containers. The device shows a pass/fail result in as little as 10 seconds and can identify leaks and channel leaks as low as 5µm.
- Flexible Membrane
Non-destructive, tool-less leak detection device designed for flexible or semi-flexible packaging. Using hybrid membrane technology, the flexible head utilizes the ATM F2338-09 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.
These non-destructive and deterministic test methods provide quick, reliable, and repeatable results enabling customers to improve the accuracy of their leak detection procedures and reduce cost as the method prevents the packaging from being damaged.
Other testing methods compatible with the Sepha Multi-Q include:
- Ramp to Event
Destructive, deterministic, quantitative test method using pressure/vacuum to ramp to an event. Used for component testing to detect weak welds/seals etc.
- Ramp to Proof Pressure
Non-destructive, deterministic, quantitative test method using pressure/vacuum to ramp to a target pressure.
Non-destructive, deterministic, quantitative test method using pressure drop/time. Typically used to test parts that must remain open to function correctly.
Multi-Q Vacuum Decay
In line with the FDA approved ASTM F2338-09 standard test method and USP 1207 guidelines, the Multi-Q with Vacuum Decay method is developed to detect leaks in vials, ampoules, bottles, pre-filled syringes, blow fill seal strips, medical devices, trays and other containers containing water-based liquid to 5μm (container & content dependent).Learn more
Multi-Q Pressure Decay
The Sepha Multi-Q with Pressure Decay method is developed to detect leaks in vials, lyophilized vials, ampoules, bottles, and other containers containing toxic product, oil-based liquid, protein/glucose or lyo/powder, or other content not suitable for Vacuum Decay leak testing.Learn More
Multi-Q Flexible Membrane
The Sepha Multi-Q with Flexible Membrane is a non-destructive pouch seal integrity testing solution. It is a tool-less machine that uses an innovative hybrid membrane in combination with vacuum decay to detect leaks, weak seals and micron holes down to 15µm in flexible and semi-flexible packaging.Learn More