Container Closure Integrity Testing
Traditionally, Dye Immersion and Microbial Immersion were the two leading methods for Container Closure Integrity Testing. Both methods are probabilistic and destructive test methods that require a significant number of sample units for validation. In 2016, the United States Pharmacopeia (USP) released guidance stating that deterministic methods are preferred over probabilistic methods. Deterministic methods are non-destructive and offer reproducible results. There are different methods of deterministic methods like vacuum decay, airborne ultrasound, high voltage leak detection that can be used for optimal detection of product-package specific applications.
As PTI’s affiliate, CCIT aims to provide customers with deterministic non-destructive technologies for container closure integrity and then provide full support in the complete implementation of CCI systems. All our testing utilizes PTI’s non-destructive technologies and test methods that are recognized by the U.S. Food and Drug Administration (FDA) and the United States Pharmacopeia (USP).
Please visit our office to learn about our CCI services and get acquainted with PTI’s technologies in person. Let’s meet to discuss the challenges you are facing and how we can help you achieve better control over your manufacturing processes. Our clients leave with more than just a test method or piece of equipment. We aim to educate and inform our clients as well as to develop the best-fit solution for your specific application.
We look forward to welcoming you.
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