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In the dynamic landscape of pharmaceuticals, ensuring the integrity of parenteral products is paramount. Container closure integrity testing is a critical part of the quality control process for parenteral products. Parenteral products, such as vials, ampoules, syringes, and cartridges, are sterile and must be protected from contamination. CCI testing ensures that the container closure system is intact until it reaches the patient.

PTI's automated CCI solutions for parenterals provide a fast, reliable, and efficient way to test CCI. These solutions are designed to meet the needs of a variety of parenteral product manufacturers, from small-scale production to large-scale manufacturing.

Why Parenteral Product CCI Testing Is Important?

Parenteral products are particularly vulnerable to contamination, as they are directly injected into the bloodstream or body tissues. Even a small leak in the packaging can allow bacteria or other contaminants to enter the product, potentially causing serious infections or other health problems. CCI testing helps to ensure that the product is sterile and free from contamination. CCI testing also helps to protect patients from infections and other adverse reactions. Automated CCIT is a reliable and precise way to test the integrity of pharmaceutical packaging, reducing the risk of human error and ensuring compliance with regulatory standards.

Automated CCI Testing Solutions Offered by PTI

1.E-Scan RTX Technology

The E-Scan RTX is a fully automated container closure integrity (CCI) testing solution for pre-filled syringes. It uses MicroCurrent HVLD technology, a non-destructive testing method that is highly sensitive to even the smallest leaks and defects. MicroCurrent HVLD technology works by applying a high-voltage, low-current signal to the syringe. The signal creates an electric field around the syringe, which is disrupted by any leaks or defects in the packaging. The E-Scan RTX detects the disruption in the electric field and generates a signal that indicates whether the syringe has passed or failed the test. The E-Scan RTX is a highly efficient solution for automated testing in the laboratory to high-volume manufacturing.

Features of E-Scan RTX

• Fully automated CCI testing for pre-filled syringes
• MicroCurrent HVLD technology for high sensitivity and accuracy
• High throughput (hundreds of syringes per hour)
• Easy integration into existing production lines

2. VeriPac LPX Technology:

The VeriPac LPX is a fully automated CCI testing solution for a wide range of parenteral packaging formats, including vials, ampoules, and cartridges. It uses vacuum decay technology, a non-destructive testing method that is highly reliable and accurate. Vacuum decay technology works by creating a vacuum inside the packaging container and then measuring the rate at which the pressure increases over time. A leak in the packaging will cause the pressure to increase more quickly, indicating that the package has failed the test. The VeriPac LPX can be used for batch release testing or inline testing. It is highly versatile and can be configured to test a variety of packaging formats and sizes.

Features of VeriPac LPX

• Fully automated CCI testing for a wide range of parenteral packaging formats
• Vacuum decay technology for high reliability and accuracy
• High throughput
• Easy integration into existing production lines

Both the E-Scan RTX and the VeriPac LPX are valuable tools for pharmaceutical manufacturers who are looking to improve the safety and quality of their parenteral products. These automated CCI testing solutions can help manufacturers reduce risk, improve compliance, and increase profitability.