Learn about dye ingress testing, its method, procedure, and USP 1207. How ensure package integrity in pharmaceutical and medical device.

The dye ingress method requires no sophisticated equipment, only a chamber and a time-dependent pressure control (vacuum–pressure cycles), and it allows for simultaneous testing …

In addition to the probabilistic methods, such as Dye Ingress, Microbial Immersion and Microbial Aerosol Challenge Testing, we also offer deterministic methods, such as Vacuum Decay, …

Get details on our Container Closure Integrity testing using dye immersion & bacterial immersion to support USP, PDA, and FDA standards

Mar 5, 2025 · The Dye Ingress Test is one of the most used methods for evaluating the integrity of container closures. This article explores the principles, methodology, advantages, limitations, …

Sep 15, 2018 · Here we provide guidelines and best practices for the qualification and/or validation and use of a dye ingress test method within a company’s holistic approach to CCI.

Additionally, we have developed a quantitative dye ingress CCIT method which can reliably detect leaks as small as 20μL in larger volume containers (125mL, 500mL and 2L media bottles) and …

The Dye Ingress test is both a destructive and probabilistic method for measuring container closure integrity. For dye ingress, samples and positive controls are submerged into a dye …

Jun 30, 2020 · While many aspects of pharmaceutical quality have evolved since the 1970 outbreak, dye ingress continues to be used to assess container closure integrity with …

Sep 15, 2018 · The paper gives an overview of the dye ingress method and there is a detailed discussion on its advantages (and when to use it) and its limitations and gaps (and when not …