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 store different infusion drugs within a single package, with each chamber separated by virtual welding. During production, storage, and transportation, the chambers remain sealed, and the virtual weld is opened manually during clinical use. Once mixed, the contents of these multi-chamber soft bags are typically unstable and cannot be stored for long periods, requiring immediate preparation before administration. This paper focuses on two key quality factors: the performance of the virtual weld and the barrier properties of the multi-chamber infusion soft bags.
The analysis and testing of weld strength is crucial for ensuring both the safety and usability of these products. The strength of the virtual weld must be sufficient to maintain integrity during storage and transport but not so strong that it hinders clinical handling. The sealing process is a critical step in production, as it directly affects the separation efficiency of the chambers. The performance of the virtual weld mainly depends on three parameters: temperature, time, and pressure. To achieve optimal results, manufacturers often conduct extensive testing using specialized equipment such as Labthink’s HST-H3 heat seal tester and XLW (PC) intelligent electronic tensile tester. These devices help measure the heat seal strength accurately. When testing finished products, samples are cut from the weld area, and the test is initiated by selecting the "heat seal strength" option on the XLW (PC). Additionally, during the development phase, manufacturers analyze the optimal temperature, time, and pressure settings using the HST-H3 heat sealer in combination with the tensile testing machine.
Barrier properties play a significant role in maintaining the stability and quality of multi-chamber infusion bags. Whether they are liquid-liquid or powder-liquid types, these products require effective barriers against oxygen and moisture penetration. A protective inner packaging layer is essential to prevent contamination and degradation. In the production process, nitrogen displacement techniques are often used to replace air within the bag. As a result, barrier property tests also include measurements of oxygen permeability, nitrogen permeability, and water vapor transmission rate. Labthink's VAC-V series of differential pressure gas permeameters are widely used for these assessments.
The application of multi-chamber bags represents a significant advancement in infusion packaging technology. As a strict requirement in pharmaceutical packaging, these products must meet rigorous standards, including tensile strength, elongation, heat seal strength, film puncture resistance, rubber stopper puncture force, and overall sealing performance. Labthink is a leading provider of inspection instruments and services, offering comprehensive quality control solutions for the global pharmaceutical industry. With years of experience, we aim to build stronger partnerships with pharmaceutical companies and research institutions. For more information or assistance, please contact Guo Sijia at gz@labthink.com.
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