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Analysis and Detection of Quality Index of Virtual Welding Strength and Barrier Performance of Multi-chamber Infusion Soft Bag Products
Multi-chamber infusion soft bags are currently categorized into two main types in the large-scale infusion industry: liquid-liquid multi-chamber bags and powder-liquid multi-chamber bags. These products are designed to contain different infusion drugs within the same package, separated into distinct chambers by virtual welding. During production, storage, and transportation, the drugs remain isolated until clinical use, where external force is applied to break the virtual welds and mix the contents. Once mixed, these multi-chamber soft bags are typically used immediately, as they are not suitable for long-term storage due to their instability after preparation.
This paper focuses on two critical quality factors of multi-chamber infusion soft bags: the performance of the virtual weld and the barrier properties. Understanding and testing these elements is essential to ensuring product safety, efficacy, and compliance with pharmaceutical standards.
First, the analysis and testing of weld strength. The strength of the virtual weld must be carefully controlled to ensure both safe handling during storage and transportation, as well as ease of use in clinical settings. If the weld is too strong, it may be difficult to open; if it's too weak, it could fail under normal conditions. This balance is crucial for the functionality of the product. The heat seal strength is mainly influenced by three parameters: temperature, time, and pressure. To evaluate this, Labthink’s HST-H3 heat seal tester and XLW (PC) intelligent electronic tensile tester are commonly used. These instruments help determine the proper welding strength by testing the actual weld joint. Manufacturers often conduct extensive trials to optimize the welding parameters, ensuring both safety and usability.
Second, the analysis and testing of barrier performance. Barrier performance plays a vital role in maintaining the integrity of the product. Whether it’s a liquid-liquid or powder-liquid multi-chamber bag, the packaging must effectively block the penetration of oxygen and moisture. To achieve this, an inner protective barrier is necessary. Additionally, during the manufacturing process, nitrogen displacement is often used to replace the air inside the bag, further enhancing its stability. Testing for gas permeability—such as oxygen, nitrogen, and water vapor—is essential. Labthink’s VAC-V series of differential pressure gas permeameters are widely used for these tests, providing accurate measurements of the packaging’s barrier properties.
The application of multi-chamber bags represents a significant advancement in infusion soft bag technology. As part of strict pharmaceutical packaging requirements, these products must meet rigorous testing standards, including tensile strength, elongation, heat sealing strength, puncture resistance, and sealing performance. Labthink has been a leading provider of inspection instruments and services for the global pharmaceutical industry for many years. With a commitment to quality control and innovation, Labthink continues to support pharmaceutical companies in ensuring product safety and compliance. We look forward to more collaborations and exchanges with enterprises and institutions in the pharmaceutical field.
For more information, please contact Guo Sijia at gz@labthink.com.