Container Closure Integrity Testing (CCIT) For Pharmaceutical Syringes
Source: Pfeiffer Vacuum Inc.
Container closure integrity (CCI) testing for pharmaceutical syringes is essential to confirm that syringes maintain their sterility and ensure the safety and effectiveness of their contents. Accurate CCI testing prevents contamination and guarantees that the injectable product remains free from leaks or defects in the seal.
- Helium Leak Detection: Pfeiffer Vacuum utilizes mass spectrometers to perform helium leak detection. In this method, helium is introduced into the syringe, and any escaping helium is detected by the mass spectrometer. This technique is highly sensitive and effective in identifying very small leaks.
- Vacuum Decay: Pfeiffer Vacuum's systems use vacuum decay testing by applying a vacuum to the syringe and monitoring pressure changes. A drop in pressure indicates potential leaks in the syringe's seal.
- Pressure Decay: Pfeiffer Vacuum's pressure decay systems involve pressurizing the syringe and measuring the rate at which the pressure decreases over time. This method helps identify leaks by detecting any pressure loss.
- Laser-Based Leak Detection: Pfeiffer Vacuum also employs advanced laser-based technologies to scan for leaks. Lasers detect irregularities in the syringe's seal by measuring changes in light transmission or reflection.
These advanced technologies from Pfeiffer Vacuum ensure that syringes meet stringent regulatory standards, maintaining the safety, efficacy, and quality of injectable pharmaceuticals throughout their shelf life.
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