Container Closure Integrity Testing (CCIT) For Pharmaceutical Vials
Container closure integrity testing (CCIT) is crucial in the pharmaceutical industry to ensure that vials maintain their sterility and product quality throughout their shelf life. These systems are designed to detect any leaks or defects in the vial's seal that could compromise the product.
Common CCIT methods include:
- Vacuum Decay: This technique involves creating a vacuum around the vial and monitoring any pressure changes, which indicate leaks.
- Helium Leak Detection: Helium, a small and penetrative gas, is used to identify leaks. The vial is exposed to helium, and any escaping gas is detected by a mass spectrometer.
- Dye Penetration: A dye solution is applied to the vial, and its penetration through the seal is monitored to detect leaks.
- Pressure Decay: This method involves pressurizing the vial and measuring the pressure drop over time to detect leaks.
- Laser-Based Systems: Laser technology is used to scan the vial for any irregularities in the seal, providing a non-destructive, highly sensitive detection method.
These container closure integrity testing systems are essential for ensuring that pharmaceuticals remain safe and effective for consumers, adhering to rigorous industry standards and regulatory requirements.
Due to these variable and unique conditions that arise for different test objects in different industries, it is highly relevant to find the most suitable leak testing technology for the individual case and also the right product for that. Pfeiffer Vacuum has the most extensive leak-testing portfolio on the market.
It does not matter whether you need to find water, oil, fuel, refrigerant, gas, steam, air, or vacuum leaks. From miniature electronics to large vessels, from media leaks to gas leaks in vacuum systems, the requirements for leak detectors are as diverse as the range of industrial products. The wide range of leak detectors from Pfeiffer Vacuum offers solutions for all these requirements, for example, portable or modular devices, helium leak detectors for sniffing, or customized leak detection solutions such as leak test modules for optimal integration into production lines or leak detectors for the Pharma and CCIT economy.