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The pharmaceutical industry has witnessed a remarkable surge in the use of pre-filled syringes, offering convenient and precise drug delivery for patients worldwide. As the demand for these pre-filled syringes continues to grow, the need for robust quality control and inspection processes becomes increasingly paramount. Traditional manual inspection methods have limitations in terms of efficiency, accuracy, and scalability, paving the way for innovative solutions that can meet the stringent demands of the modern pharmaceutical landscape.

Robotic inspection of pre-filled syringes is a cutting-edge technology that holds the potential to revolutionize the quality assurance process in pharmaceutical manufacturing. Robotic inspection systems offer the advantages of precision, speed, and consistent performance, addressing some of the most critical challenges associated with conventional inspection methods. This novel approach aims to enhance product safety, improve quality control, and streamline the production process, ultimately benefiting both pharmaceutical companies and, more importantly, patients.

What are the Challenges Associated with Robotic Inspection of Pre-filled Syringes?

Robotic inspection of pre-filled syringes present various challenges that are important to address to ensure the safety and quality of pharmaceutical products. Some of the key challenges associated with robotic inspection of pre-filled syringes include:

• Fragility of syringes: Pre-filled syringes are delicate and can be prone to breakage or damage during the inspection process, especially when handled by robots. Ensuring gentle and precise manipulation by the robotic systems is crucial to avoid any product loss or compromise.
• Contamination risk: Maintaining a sterile environment is crucial in the pharmaceutical industry. Robotic inspection systems need to be designed and maintained carefully to prevent any potential contamination from the robot itself or the inspection environment.
• System validation and compliance: Robotic inspection systems used in the pharmaceutical industry must adhere to strict regulatory standards and guidelines. Validating the robotic inspection system and ensuring compliance with regulatory requirements can be a complex and time-consuming process.
• Cost considerations: Implementing robotic inspection systems can involve significant upfront costs. Pharmaceutical companies must carefully evaluate the cost-effectiveness and return on investment of such systems.
• Flexibility and adaptability: The pharmaceutical industry may introduce new products or modify existing ones over time. Robotic inspection systems must be flexible and adaptable to accommodate these changes without significant reconfiguration or reprogramming.

E-Scan RTX Robotic Test System

The E-Scan RTX platform is a fully automated system that uses MicroCurrent HVLD technology to test the container closure integrity of pre-filled syringes. It is a reliable and versatile solution that can be customized to fit your production needs.

The system uses a robotic arm to pick up syringes from a conveyor belt and rotate them through two test stations. The first station checks for needle shield defects, and the second station inspects the rest of the syringe body. The test results are automatically generated and indicate whether the syringe is passed or failed. The adjustable failure reference allows you to set the LOD (limit of detection) for the test. This means that you can customize the test to be more or less sensitive, depending on your specific requirements. After the test, the syringes are automatically loaded back to the tray or a reject tray.

Here are some specific benefits of the E-Scan RTX platform:

• It is fully automated, which can help to improve efficiency and accuracy.
• It uses MicroCurrent HVLD technology, which is a sensitive and reliable method for detecting leaks.
• It is versatile and can be customized to fit your production needs.
• It is easy to use and maintain. .

Robotic inspection of pre-filled syringes presents a promising path forward for the pharmaceutical industry, offering unprecedented levels of accuracy, efficiency, and compliance with regulatory standards. By harnessing the power of robotics, pharmaceutical companies can elevate their quality control processes, uphold their commitment to patient safety, and stay ahead in an increasingly competitive market.

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.