MEDICAL DEVICE
LEAK TESTING

Acceptance limits are established during validation based on:

• risk analysis (ISO 14971)
• product design and materials
• regulatory requirements
• real-use conditions

The limit is typically correlated to a calibrated reference leak representative of a critical failure mode.

No. When properly implemented, non-destructive leak testing:

• does not compromise sterility
• does not damage the product or packaging
• supports sterile barrier integrity validation

It is specifically designed for use in controlled medical and pharmaceutical manufacturing environments.

Sensitivity depends on the chosen technology:

• pressure and vacuum methods detect small to fine leaks
• mass flow provides fast and repeatable measurements
• tracer gas methods detect extremely low leak rates

The target leak rate is defined according to product risk, function, and clinical use.

Yes. Leak testing systems can be integrated:

• as manual assisted stations
• in semi-automatic cells
• fully automated in-line production systems

Automation improves repeatability, reduces operator influence, and ensures full data traceability.

Yes. Leak testing is fully compatible with medical regulatory frameworks, including:

• ISO 11607 for sterile barrier systems
• ISO 13485 quality management systems
• FDA and MDR requirements, depending on the market

Leak testing equipment must be validated (IQ/OQ/PQ) and acceptance limits must be justified through risk analysis.

Sterile medical packaging is commonly tested using vacuum decay technology, as defined in ASTM F2338.
The package is placed in a sealed chamber under vacuum, and any pressure increase indicates a leak.

This method allows:

• non-destructive testing
• high sensitivity
• compliance with sterile barrier system requirements
• in-line or at-line production testing

Several technologies are used depending on the application:

• Pressure decay: measures pressure loss over time in non-porous devices
• Vacuum decay: detects pressure increase in a vacuum chamber, widely used for sterile packaging integrity
• Mass flow: measures the flow needed to maintain a target pressure
• Tracer gas detection: offers very high sensitivity for critical or micro-leak applications

Each method is selected based on material, internal volume, target leak rate and cycle time.

Non-destructive testing allows manufacturers to:

• perform 100% production testing
• preserve sterile or high-value products
• improve traceability and quality investigations
• reduce scrap and overall cost of quality
• comply with medical and regulatory standards

It is particularly suited for high-risk or regulated medical applications.

Leak testing is commonly applied to:

• catheters, tubing and fluid transfer sets
• balloons, reservoirs and flexible devices
• valves, connectors and sealed assemblies
• implantable or single-use medical devices
• sterile packaging such as blisters, pouches and trays

Any device where a leak could impact patient safety, performance, or sterility must be tested.

Non-destructive leak testing is a quality control method used to detect leaks without damaging the medical device or its packaging.
It ensures the functional integrity of the device and, when applicable, the integrity of the sterile barrier system, while allowing the tested product to remain usable.

This approach is essential in medical manufacturing where safety, traceability, and regulatory compliance are critical.