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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.

In the world of pharmaceuticals, the integrity of vial container closures is a matter of utmost importance. Vials are small, cylindrical containers made of glass or plastic, designed to store a wide range of pharmaceuticals, including vaccines, medications, and other sensitive compounds. Their significance lies in their ability to preserve the integrity and potency of these substances. Vials shield their contents from external factors like air, moisture, and contaminants, ensuring that the product remains uncontaminated and effective.

Package integrity testing of vials is crucial to maintain the high standards of pharmaceutical products. Any breach in the vial's integrity can lead to contamination, rendering the contents ineffective or even harmful. It's not just about preserving the product; it's also about ensuring the safety of the end-users. Therefore, advanced leak testing strategies play a vital role in guaranteeing that vials are sealed securely. Vial leak testing involves identifying leaks or breaches in the vial container closures. The main goal is to confirm that the closure system maintains an airtight seal, preserving the sterility and efficacy of the product. Vial leak testing can be performed using various methods, each with its own advantages and limitations.

1. PTI's MicroCurrent HVLD Technology

PTI's MicroCurrent High Voltage Leak Detection (HVLD) is a Container closure integrity testing method that plays a crucial role in ensuring vial integrity, for liquid fill applications including proteinaceous products and small molecule liquids. It operates on a fundamental principle: detecting breaches by applying high voltage to the vial's container closure. When high voltage is applied, if there is even a minor breach in the seal, the current will pass through the vial, alerting the system to potential defects. This technique is incredibly sensitive and can identify breaches that might otherwise remain undetected by traditional methods.

One key advantage of MicroCurrent HVLD is its non-destructive nature. Unlike destructive testing methods, this technology does not harm the vial or its contents in any way. This unique method utilizes about 50% less voltage and exposes the product and environment to less than 5% of the voltage when compared to conventional HVLD solutions. Its ability to pinpoint even minute defects in vial closures ensures that products maintain their sterility and efficacy.

2. PTI's VeriPac Vacuum Decay Technology

VeriPac Vacuum Decay Technology is another container closure integrity test (CCIT) used for vial leak testing, for both liquid fill and lyophilized applications. This method relies on creating a controlled environment within which the vial is tested. By introducing vacuum and pressure differentials, VeriPac can identify leaks with remarkable accuracy. If there's a breach in the vial closure, the changes in pressure within the controlled environment will be detected, indicating a potential defect.

One of the standout features of VeriPac is its ability to pinpoint defects with exceptional precision. It can detect leaks in various vial types, whether they are glass or plastic, and offers a versatile solution for pharmaceutical quality control. Like MicroCurrent HVLD, VeriPac is non-destructive, ensuring that the vials and their contents remain unaltered during the testing process. This makes VeriPac a reliable choice for pharmaceutical companies looking to maintain the highest standards of quality and safety in their products.

In the pharmaceutical industry, maintaining vial container closure integrity is paramount. The consequences of compromised vials can be detrimental, affecting not only the product but also the health and safety of the end-users. Advanced leak testing strategies, such as PTI's MicroCurrent HVLD and VeriPac Vacuum Decay technologies, provide innovative solutions to this challenge. By using these cutting-edge methods, manufacturers can ensure the highest standards of quality and safety in their products.