The integrity of the container closure system is crucial for ensuring that all portions of pharmaceutical products stay sterile during transportation, storage, and usage. Product contamination occurs as a result of leaking containers or closures. A non-destructive packaging inspection technology used to keep an aseptic barrier against possible contaminants is called Container Closure Integrity Testing (CCIT), commonly known as leak detection. The sterility and product quality of sterile final pharmaceutical and biological products should be maintained throughout their shelf life using container closure systems.
Various CCI Services
For testing the integrity of many package formats, CCIT offers expertise for the application of the best deterministic inspection technologies and test methodologies.
Feasibility Studies for Testing Package Quality
The first stage in evaluating and determining the optimal CCI technology and test technique for a certain application is to conduct an experimental or a more extensive feasibility study. To evaluate if a proposed CCI solution works and establish optimal test circumstances and Limit of Detection (LoD) is the goal of a feasibility study. CCIT’s aim is to provide clients with deterministic package integrity test solutions and help them in the installation of comprehensive CCI systems. This process starts with a client's problem description and ends with a clear approach to ensuring container closure integrity. Feasibility studies by CCIT for package quality testing provide customers with a complete report on the quantitative test technique.
Test Method Development for CCI Testing
CCIT conducts feasibility studies and develops test methods for package quality testing, recommending test methods based on the customer's needs for a given package or container. CCIT's Test Method Development focuses on the package/product characteristics and the extent to which the package attributes must be challenged to ensure closure integrity. The Test Method Development comprises adjusting test parameter settings for a given test method, such as vacuum or high voltage, test cycle periods, and pass/fail criteria. The comprehensive report will include precise test processes and criteria, as well as test findings and leak rates that the customer may expect, along with conclusions and recommendations. Before being included in the final report, all of the worked-out test methods go through validation checks to verify that they are reproducible, accurate, specific, exact, and acceptable for their intended application.
Equipment and Application Support
CCIT offers analytical leak detection services as well as package integrity testing equipment and applications knowledge. We also provide demonstrations on equipment and application services.
At CCIT's laboratory, we have the following technological platforms:
- VeriPac - Vacuum Decay applications
- E-Scan - MicroCurrent High Voltage Leak Detection( MicroCurrent HVLD)
- Seal-Scan®/Seal-Sensor - seal inspection through Airborne Ultrasound
CCIT also offers the following services:
- Installation, training, and validation services for CCI applications
- Calibration, technical assistance, and overall equipment maintenance
- Navigating USP 1207/ASTM/ISO standards - CCIT and regulatory consultancy services
CCIT.s.a is Europe’s leading package testing equipment provider for pharmaceutical, medical device, food, and nutrition companies. We have expertise in Test Method Development & Feasibility Studies. We focus on non-destructive technologies like Vacuum Decay, MicroCurrent HVLD, Airborne Ultrasound, and Helium Leak Detection for package quality testing.