Blogs

Automated Container Closure Integrity Testing (CCIT) is a specialized form of testing that focuses on verifying the integrity of the container closure systems of several types of containers used to store and transport products. This can include vials, pre-filled syringes, bottles, pouches, and other types of containers. The container closure system includes the closure device (such as a stopper or cap) and the container or package itself (such as a glass or plastic vial or bottle), and it is essential to ensure that it is properly sealed so that it does not allow any leaks or contaminants to enter the container.

Automated CCI testing of pre-filled syringes involve using specialized testing equipment and techniques to simulate real-world conditions and test the container closure system's integrity. This testing process can be done in the laboratory by an operator or fully automated to increase efficiency and accuracy.

Testing Pre-filled Syringes Using E-Scan RTX

The E-Scan RTX platform is a modular, fully automated container closure integrity solution for pre-filled syringes. The RTX is a practical and dependable CCI solution with a dynamic robotic design that is adjusted to meet your production needs. This robust, flexible platform uses MicroCurrent HVLD technology, a revolutionary form of HVLD that is the optimal CCI solution for fragile, high-risk biologic liquids. It is appropriate for batch release testing at the production line, in the lab, and provides a quick PASS/FAIL result with a test cycle of only seconds.

A robotic arm will track and pick up nested syringe trays from a standard single lane conveyor. The robot removes the syringes from the nested tray and rotates the syringes through two test stations, one to detect needle shield defects and the other to inspect the rest of the syringe body. The test starts automatically and gives a fixed PASS/FAIL signal on completion of the test. An adjustable failure reference can be set to allow PASS/FAIL based on a predetermined LOD (limit of detection) setting in the initial recipe. After testing, syringes are automatically loaded back into the syringe tray, defective syringes are collected in the reject tray.

Benefits of E-Scan RTX

• 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 a recommended method for parenteral liquid package inspection.
• Robust method and good Signal-Noise-Ratio between good and defective products.
• Low voltage exposure reduces the production of ozone.

Automated pre-filled syringe testing is critical to ensuring the safety and efficacy of pre-filled syringes used in the pharmaceutical industry. By using automated testing techniques, manufacturers can ensure that the container closure system is reliable and free from defects, reducing the risk of contamination or other safety concerns.

Several leak detection methods, that are deterministic and non-destructive, are already available in the market. Pharmaceutical companies are urged to use technologies that significantly enhances quality assurance and leak detection rates. Appropriate leak detection technology is selected based on the specific characteristics of the product and container, such as conductivity, headspace parameters, contents, or API. Historically, dye immersion and microbial immersion have been the two main methods of vial integrity testing. Recently, the USP has issued guidelines that require critical methods to achieve more reproducible and predictable outcomes. USP <1207> encourages a move towards more deterministic methods, recommending the avoidance of dye immersion tests and the use of quantitative, non-destructive technologies instead.

Why High Voltage Leak Detection Method is Preferred for Testing Vials?

High Voltage Leak Detection or HVLD is a deterministic, non-destructive leak detection method to evaluate vials, cartridges, and other liquid-filled parenteral products for Container Closure Integrity. The current generation of PTI’s MicroCurrent HVLD may be utilized with a wide range of liquid-based products, from low conductivity sterile water for injection to highly proteinaceous drug preparations in suspensions. It is one of the most effective online container closure testing methods, requiring just minor infrastructure modifications. When compared to conventional HVLD solutions, MicroCurrent HVLD utilizes approximately 50% less voltage and exposes the product and environment to less than 5% of the voltage. This method is non-invasive and requires no sample preparation. Like vial leak testing, another major application of MicroCurrent HVLD is pre-filled syringe testing.

Working Principle of MicroCurrent HVLD Technology

In this method, the container is scanned using a set of high voltage electrode probes. A high voltage is applied to one side of the container, while a ground probe is attached to the other. If there is no leak in the package, the two container walls (high voltage side and ground side) offer complete electrical resistance, and no substantial current is measured flowing through the vial. If a micro-leak or fracture occurs in one of the container walls, the break-down resistance is achieved, and the current flows through. HVLD is the only leak detection method that does not require mass to travel through a defect location, instead of requiring just electricity to pass through a crack. Because of this feature, HVLD is sensitive to leaks that conventional leak detection technologies are unable to detect.

MicroCurrent HVLD Technology Advantages

• Deterministic and non-destructive test method.
• High level of repeatability and accuracy.
• Ensure more accuracy and dependability in results.
• At high production rates, both offline and 100% online inspections are performed.
• Simplifies the inspection and validation procedure.
• Highly effective in all parenteral preparations, even liquids with extremely low conductivity (WFI).
• Outlined in the USP 1207 Guideline.

Pharmaceutical containers like vials protect the product from contamination (sterile barrier) and prevent changes in product quality caused by external factors. In order to determine the functionality of such systems, container closure integrity testing is performed. CCIT provides sophisticated analytical methods for evaluating pharmaceutical containers.