CCIT Glossary

This glossary defines key Container Closure Integrity Testing (CCIT) terms commonly used in pharmaceutical and medical device packaging. The definitions are written to support regulatory clarity, technical understanding, and consistent terminology across development, validation, and manufacturing.

Container Closure System (CCS)

The complete packaging system that encloses and protects a product. This includes the container, closure, seal, and any sealing interfaces that together maintain sterility and product quality.

Container Closure Integrity Testing (CCIT)

A scientific testing approach used to evaluate whether a container closure system maintains its primary barrier protecting the product for it’s intended use. CCIT assesses the integrity of the entire system, not individual components.

Deterministic CCIT

A category of CCIT methods based on measurable physical principles. These methods produce objective, repeatable results with defined sensitivity and detection limits, making them suitable for validation and regulatory review.

Probabilistic CCIT

Testing methods that rely on a series of events and conditions that create a lesser probability of effectiveness and may use subjective interpretation. Results depend on test conditions, operator judgement, and chance, rather than direct measurement of a physical parameter.

Leak

Any unintended pathway through which gas, liquid, or microorganisms can pass into or out of a sealed package, potentially compromising sterility or stability.

Leak Rate

A quantitative measure of how much gas or liquid passes through a leak over a defined period of time. Leak rate is typically expressed in units such as mbar·L/s or standard cubic centimetres per second (sccs).

Maximum Allowable Leakage Limit (MALL)

The highest leak rate a package can tolerate without risking sterility loss or product degradation during its intended shelf life. MALL links package integrity testing to real-world risk.

Limit of Detection (LOD)

The smallest leak rate that a CCIT method can reliably detect with confidence. LOD is a critical parameter for method selection and validation.

Microbial Ingress

The entry of microorganisms into a sealed package through a defect in the container closure system. Microbial ingress is a consequence of integrity failure, not a standalone quality attribute.

Vacuum Decay

A deterministic CCIT method that detects leaks by monitoring pressure changes in a vacuum test chamber. It is widely used for rigid, semi-rigid, and flexible packaging formats.

High Voltage Leak Detection (HVLD)

HVLD is a deterministic CCIT technique used primarily for liquid-filled containers. It identifies leaks by detecting changes in electrical conductivity caused by product escaping through a defect.

Helium Leak Detection

A highly sensitive deterministic method that uses helium as a tracer gas and mass spectrometry to identify and quantify very small leaks, often during development and root-cause analysis.

Inline CCIT

Integrity testing performed directly on the production line to monitor process performance and detect defects in real time.

Offline CCIT

Testing conducted away from the production line, typically in laboratory or controlled environments, for development, validation, or investigation activities.

USP <1207>

A regulatory guidance chapter that outlines best practices for container closure integrity testing, emphasising deterministic, science-based methods.