Container closure (CCI): Dye ingress methods for container-closure integrity testing: An industry position paper
Dye Ingress Methods for Container-Closure Integrity Testing: An Industry Position Paper provides guidelines and best practices for the qualification and/or validation and use of a dye ingress test method within a company’s approach to container-closure integrity (CCI).
Written by the BIoPhorum Fill-Finish Container-Closure Integrity Testing (CCIT) Workstream, the paper summarizes the results of a cross-industry survey of CCIT methods. This found that 11 of the industry's top biopharmaceutical companies use dye ingress testing in 78% of CCIT situations. Despite not being the latest technology or particularly sophisticated, the survey shows that this method is vitally important to the industry. If your company depends on dye ingress to test and release your biopharmaceutical product, then this paper is a must-read.
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 to use it). It also examines the critical factors and parameters that must first be considered and understood to adequately qualify a CCIT method. These include the limit of detection, the 20-µm ‘standard’, tracer liquid (dye) choice and surfactant use, and detection (UV and visual).
The Workstream suggests that any CCIT method, including dye ingress, should be qualified or validated for its intended use based on available scientific knowledge. This should be performed by qualified personnel using qualified equipment and consider the available guidance on validation, sensitivity and specificity.
The team considers that the most important factor of any test method is not whether a CCIT method is ‘preferred’ but whether it is well developed, qualified and fit for its intended purpose. It says that although the method is not always product- or container-compatible, where appropriate, dye ingress continues to provide container assurance.