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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.

Automated Container Closure Integrity Testing (CCIT) of pre-filled syringes is a critical quality control process that ensures the product inside the syringe remains safe and effective during its shelf life. Pre-filled syringes are used to package and deliver various injectable drugs, such as vaccines, insulin, and other biologics.

The container closure integrity of pre-filled syringes can be compromised due to various factors such as: microcracks, defects in the rubber stopper, or improper sealing. To detect any potential defects in pre-filled syringes, automated CCI testing is done. This testing involves subjecting the pre-filled syringe to multiple conditions to check for any leakage or breakage in the container or closure.

Automated CCI testing of pre-filled syringes can be done utilizing techniques such as vacuum decay, high voltage leak detection, and tracer gas detection. These methods involve the use of specialized equipment to subject the pre-filled syringe to certain conditions including vacuum, high voltage, or exposure to a tracer gas. Any potential leaks or breakages in the container or closure can be detected by monitoring the pressure or electrical conductivity changes, or by the presence of the tracer gas

Automated CCI testing is crucial to ensure the safety and efficacy of pre-filled syringes. It is a reliable and efficient way of detecting potential defects in pre-filled syringes and ensuring that only products which meet the required quality standards are released to the market.

The E-Scan RTX platform is PTI’s fully automated, modular container closure integrity testing solution for pre-filled syringes. The RTX is a practical and reliable CCI solution that features a dynamic robotic design, tailored to fit your production requirements. This robust, adaptable platform utilizes MicroCurrent HVLD technology, a revolutionary form of HVLD that is the ideal CCI solution for high-risk, delicate biologic liquids. It provides a rapid PASS/FAIL result – its test cycle is only seconds – and is suitable for batch release testing, in line on production or in the lab.

PTI’s MicroCurrent HVLD technology uses a unique mode of DC voltage, applying no more than 50% of the voltage used on conventional high-voltage technologies. The nature of the PTI solution allows for the detection of leaks in packages with liquids of extreme low conductivities, including packages containing sterile water. The low voltage and current applied to the container also reduce the voltage the product is exposed to during the test. This technological advantage makes it the ideal solution for all parenteral and biologic solutions.

• MicroCurrent HVLD technology is effective across all parenteral products, including biologics and extremely low conductivity liquids including sterile water (WFI).
• Listed in USP Chapter 1207 as the recommended method for parenteral liquid package inspection.
• Robust method and good Signal-Noise-Ratio between good and defective products.
• Low voltage exposure reduces production of ozone.