Our Approach
An approach based on international recommendations to guarantee the integrity of your sterile products.
Regulatory Framework
Our tests are carried out in compliance with the requirements of the FDA, USP 1207 (United States Pharmacopeia), and EU GMP Annex 1 relating to the integrity of sterile product containers. This regulatory framework requires the demonstration of the physical integrity of all containers, from production through to patient administration.
USP 1207 Reference Framework
For the performance of CCIT, we rely on the recommendations of USP 1207 (Package Integrity Evaluation – Sterile Products). This reference framework advocates prioritizing so-called "Deterministic leak test technologies" for their precision, reproducibility, and the possibility of fully automated processes.
When the item being tested does not allow the application of a deterministic method, we use "Probabilistic leak test technologies" as an alternative, in accordance with the recommendations of the document.
Our Testing Methods
Deterministic technologies as a priority, supplemented by probabilistic methods when necessary.
Vacuum Decay - DETERMINISTIC
ASTM F2338 Standard: The container is placed in a sealed chamber under controlled vacuum. Any leak causes a detectable pressure variation, allowing a conclusion of integrity loss to be drawn. Non-destructive, fast method, adaptable to many formats (vials, syringes, cartridges).
Pressure Decay - DETERMINISTIC
ASTM F2095 Standard: A constant pressure is applied to the container, then the variations resulting from any leaks are measured with precision. This technique stands out for its speed, reliability, and compliance with USP <1207>.
Bubble Emission - PROBABILISTIC
ASTM F2096 / ASTM D3078 Standards: The container is immersed in a liquid and subjected to pressure or vacuum. The appearance of bubbles indicates the presence of a leak. A simple method to implement, used as an alternative when deterministic methods are not applicable.
Tracer Liquid - PROBABILISTIC
ISO 11040 (syringes) / ISO 8871-5 (vials): A tracer liquid is used to detect leaks by visual inspection. This method applies specifically to syringes and vials according to the corresponding ISO standards, when a deterministic approach is not feasible.
Methods Comparison
Choosing the right method according to your container and regulatory requirements.
| METHOD | TYPE | STANDARD | PRINCIPLE | SUITABLE CONTAINERS |
| Vacuum Decay | DETERMINISTIC | ASTM F2338 | Pressure variation under vacuum in a hermetic chamber | Vials, syringes, cartridges |
| Pressure Decay | DETERMINISTIC | ASTM F2095 | Pressure drop measurement after pressure application | Blisters, sachets, flexible pouches |
| Bubble Emission | PROBABILISTIC | ASTM F2096 / D3078 | Visual detection of bubbles during immersion | Rigid and semi-rigid containers |
| Tracer Liquid | PROBABILISTIC | ISO 11040 / ISO 8871-5 | Visual inspection with tracer liquid | Syringes, vials |
Frequently Asked Questions
Vacuum decay detects leaks by pressure variation in a vacuum chamber, while pressure decay applies positive pressure and measures the fluctuations resulting from a potential leak. Both methods are non-destructive, precise, and compliant with USP 1207.