Container Closure Integrity Testing (CCIT)
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Pharmaceutical and some food products are expected to be free from microbial contamination and safe to use right from production throughout their shelf-life, but different products and container types necessitate different testing methods according to their content, material of packaging, design and regulatory requirements.
Container Closure Integrity Testing (CCIT), commonly referred to as leak detection, is a non-destructive packaging inspection system to maintain an aseptic barrier against potential contaminants. Is a deterministic testing procedure, so it is less subject to error, is repeatable and gives quantitative and predictable results.
CCIT detects defects that demonstrate breach of the container and/or closure system.
Patient and consumer health and safety is the principal reason why testing methods are put into place. Product sterility and consumer safety begins at the product development phase by evaluating the suitability of primary packaging in its ability to offer a sterile barrier thanks to its container closure system which should not result in contamination or leaks of the drug or product.
The United States Pharmacopeia (USP) and Food and Drug Administration (FDA) impose strict requirements for Container Closure Integrity Testing (CCIT).
As per the 21 Code of Federal Regulations (CFR) part 211.94, container closure systems must provide adequate protection against anticipated external factors in storage and use, that can cause deterioration or contamination of the drug product. It also establishes the standards or specifications and methods of testing in the validation procedures.
The leak detection guidelines establish that container security testing methods should use analytical detection techniques appropriate to the method and compatible with the specific product being tested. Validation of methods should be specific to the product container and closure system or product type.
The method of CCIT chosen will vary according to the desired result like the leak rate measurement of the entire container, potential for microbial ingress, detection of presence of leak paths etc.
Container Closure Integrity Testing Method requires the creation of positive and negative controls, taking into consideration the design, material, expected package leak features and content. This is done to mimic defects and is inspected together with the intact samples.
Laser drilled holes is one of the ways in which Positive controls can be created. With laser drilled hole simulation, the sample geometry remains intact and the simulation resembles the natural defects in glass (cracks) and polymers (micro holes), as leaks that occur naturally are likely to be meandering paths and not to perfect holes. The size of the simulated leak in the laser-drilled hole requires calibration.
Other than the leak test method and positive and negative sampling, which should be sufficient enough to provide adequate assurance of package integrity (USP <1207.1>), the criteria for acceptance must also be determined and accordingly all negative controls should pass while all positives must fail. A lower and an upper limit of detection should also be established, followed by a validation protocol that highlights the parameters established during the process. Validation is essential to prove test method precision (demonstrating repeatability), accuracy (correctly identifying leaks), and detection limit. In case of modifications in package design and material or processing the CCIT method should always be re-evaluated too for ensuring patient and consumer safety.
Common CCIT methods: