Discover Container Closure Integrity Testing Solutions at Pack Expo 2019
Discover our Container Closure Integrity Testing solution to ensure the integrity of your pharmaceutical containers or medical devices
The Sepha Multi-Q CCI solution could be the right system for you. In line with FDA and USP regulations the Sepha Multi-Q is a deterministic and non-destructive leak test system designed to detect leaks in nonporous, rigid and flexible packaging.
To ensure product safety throughout its shelf life, your containers need to protect your sterile products from potential contamination. The Sepha Multi-Q can help you demonstrate the integrity of your container and closure systems by testing them for leaks. The test methods can be used for stability testing, clinical trials and in process quality control testing.
Non-destructive CCIT leak test methods
The Sepha Multi-Q is a non-destructive, deterministic and multi-functional system. The lab-scale unit works in combination with interchangeable attachments to fit the full range of container types available on the market.
Depending on the type, size and content of the packaging, the machine can utilize Vacuum Decay technology, Pressure Decay technology and a Flexible Membrane. Unlike traditional, destructive methods that can be time consuming and producing excessive waste, all our methods are non-destructive. They can be used 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.
USP 1207 Guidelines
All methods are in line with new USP 1207 guidelines that focus on deterministic and objective methods to provide reliable and repeatable test results.
Leak Test Methods
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.
Pack Expo 2019
To see a demo of the Multi-Q, visit us at Pack Expo. We will be joining our distributor Thomas Packaging in the North Hall on booth #205. In addition the the Multi-Q they will have a range of other Leak Test, Deblistering and small Packaging solutions on show including:
- Sepha VisionScan – a non-destructive, deterministic, tool-less blister leak test device
- Sepha BottleScan – a non-destructive, deterministic, tool-less multi-bottle leak tester for induction-sealed pharmaceutical bottles.
- Sepha MediScan – a tool-less, non-destructive and deterministic leak detection device for non-porous pouches, sachets and medical device packaging.
- Sepha EZ Blister – a table top blister packaging machine ideal for clinical trials.
- Sepha PressOut Universal – a high-speed automated deblistering machine that recovers tablets and capsules from rejected blister packs including child resistant and peelable packs.
We look forward to seeing you in Las Vegas!