The Sepha Multi-Q Pressure Decay Method method enables manufacturers to test the integrity of container closure systems of pharmaceutical containers including vials, ampoules, bottles and other containers that contain toxic product, oil based liquids or lyo/powder. CC systems need to protect sterile products from potential contamination to ensure product safety throughout its shelf life.
The Multi-Q can identify leaks and channel leaks as low as 5µm (dependent on container type and content). The method is deterministic and non-destructive and can be used for stability testing, clinical trials and in process quality control testing.
Pressure decay testing is referenced in the revised USP 1207 guidance as one of the recommended deterministic test CCIT methods that are preferred over probabilistic procedures such as the bubble test or blue bath method. The revised chapter will be applied to vials, ampoules, syringes, and bags.
In addition, 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.
Multi-Q Pressure Decay Video
Multi-Q Brochure Download
Download the Sepha Multi-Q brochure by completing the form on the right to find out more about the versatile Container Closure Integrity Test system and learn how you can help improve your package assurance process.
If you would like to discuss your CCIT requirements in more detail, please get in touch on +44(0)2890 48 48 48, +1 616-888-9081(USA) or via the button below.
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