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The integrity of pre-filled syringes is a major concern in pharmaceutical manufacturing, as these products must remain sterile and secure throughout their entire lifecycle. As the demand for injectable medications and therapies grow, so does the need for reliable methods to confirm the integrity of syringe containers. Container closure integrity (CCI) testing is an integral process in verifying that pre-filled syringes maintain sterility and secure their contents throughout their lifecycle. With ongoing advancements in testing technology, pharmaceutical manufacturers now have access to more precise and efficient solutions to evaluate syringe integrity. These innovations help streamline the testing process, reduce operational costs, and maintain high-quality standards, supporting compliance with industry regulations and ensuring the safety of patients who rely on injectable therapies.

Why Pre-Filled Syringe Integrity Matters?

Pre-filled syringes (PFS) have become a widely preferred choice in pharmaceutical packaging due to their convenience, accurate dosing, and enhanced safety. As a critical component of modern drug delivery systems, maintaining their integrity impacts both patient health and pharmaceutical quality. Here’s why it matters:

• Preserving Sterility: Pre-filled syringes are often used for injectable medications, which must remain sterile to avoid contamination. A breach in integrity can lead to microbial ingress, risking patient health and compromising the medication's safety.
• Ensuring Dosage Accuracy: Damage or leaks in the syringe can lead to product loss, affecting the precision of the delivered dose. For drugs with critical dosing requirements, such as biologics or vaccines, this could significantly impact treatment outcomes.
• Protecting Drug Stability: Many medications in pre-filled syringes are sensitive to environmental factors like oxygen, moisture, or light. A loss of container closure integrity (CCI) could expose the drug to these elements, reducing its potency or rendering it ineffective.
• Mitigating Contamination Risks: Leaks in the syringe body or seal can allow external contaminants to enter, which may degrade the medication or pose direct health risks to patients.
• Enhancing Patient Trust and Brand Reputation: Patients and healthcare professionals rely on pre-filled syringes for their convenience and reliability. Compromised integrity not only risks patient health.

CCI Testing of Pre-filled Syringes Using E-Scan MicroCurrent HVLD

Container Closure Integrity (CCI) testing ensures pre-filled syringes maintain sterility and protect the quality of their contents. The E-Scan MicroCurrent High Voltage Leak Detection (HVLD) system provides an advanced, non-invasive method for detecting leaks in pre-filled syringes. E-Scan 605, 615 and 655 models employs MicroCurrent conductivity technology (HVLDmc) for non-destructive container and product testing, utilizing lower voltage levels compared to other conductivity-based methods. This non-contact test requires no sample preparation. It is compatible with a wide range of liquid-based products, including low-conductivity sterile water for injection (WFI) and protein-based products with suspensions. Its features include rapid test cycles, simple operation, quick changeovers, and easy recipe configuration, enabling flexibility across diverse applications.

The testing process uses electrode probes to scan sealed, non-conductive containers made of materials such as glass, plastic, or poly-laminate. The container must be liquid filled. If a defect like a pinhole or crack exists, the system detects changes in resistance and current flow, indicating a breach. The approximate location of the defect can also be identified on the advanced lab R&D models. E-Scan MicroCurrent technology is scalable and adaptable, offering configurations for both laboratory testing and fully automated production lines, making it a versatile solution for CCI testing in pharmaceutical packaging.

Benefits of MicroCurrent HVLD Technology

• Non-destructive, non-invasive, no sample preparation
• Highly effective across all parenteral products, including extremely low conductivity liquids (WFI)
• Ensure higher levels of accuracy and reliability in results
• Characterizes overall quality and uniformity of the seal
• Offline and 100% online inspection at high production speeds
• Simplifies the inspection and validation process
• Referenced in USP 1207 Guideline

E-Scan MicroCurrent HVLD Technology brings a modern approach to pre-filled syringe testing, focusing on precision, efficiency, and non-destructive methods. It supports the pharmaceutical industry’s pursuit of reliable quality assurance while preserving product integrity and reducing waste. By embracing this advanced solution, manufacturers enhance their ability to meet stringent standards, ensuring safe and effective delivery of medications. This technology embodies innovation in packaging integrity, meeting the demands of both healthcare providers and patients.