Multi-chamber infusion soft bags are currently divided into two types in the large infusion field, one is a liquid-liquid multi-chamber bag, and the other is a powder-liquid multi-chamber bag; it means that it will be in the process of production, storage and transportation. Different infusion drugs are packaged in the same package and separated in different chambers by virtual welding. In the clinical use, the virtual welding is opened by external force, and after mixing, the multi-cavity soft liquid soft bag products are mainly suitable for unstable after preparation. It cannot be stored for a long time, and it is necessary to temporarily prepare an infusion preparation for clinical use. This paper only analyzes the two quality key factors of the virtual welding performance and barrier performance of multi-chamber infusion soft bag products.
1. Analysis and detection of the weld strength The liquid weld strength of the liquid-liquid multi-chamber bag and the powder-liquid multi-chamber bag must ensure the convenience and safety of the clinical use of the product and the separation efficiency of the product during storage and transportation. Destruction, so multi-cavity bag product virtual seal process control is a key step in the entire production process. The performance of the virtual soldering depends mainly on the three parameters of temperature, time and pressure during the sealing. In the use of multi-chamber bags, on the one hand, in order to ensure the safety of storage and transportation, on the other hand, to ensure the ease of operation of clinical use, the strength (or called heat sealing strength) of the virtual welding cannot be too large or too small. How to control this indicator has become the focus of multi-cavity infusion bag manufacturers. Labthink's HST-H3 heat seal tester and XLW (PC) type intelligent electronic tensile tester are professionally used for the detection of this indicator in multi-chamber infusion software. When testing the finished multi-chamber bag, the sample is prepared by directly cutting the solder joint, and then the test is automatically completed after selecting the "heat seal strength" test item on the XLW (PC). In addition, as an infusion product manufacturer, in order to pursue proper welding strength, it is often necessary to study the three parameters of temperature, time and pressure of the welding seal. At this time, it is necessary to use the HST-H3 heat sealing tester with the intelligent electronic tensile testing machine. The heat sealing temperature, time and pressure parameters of Zui Jia were analyzed.
2. Analysis and detection of barrier performance
Barrier performance is an important factor affecting the quality of multi-cavity bags. Whether liquid-liquid multi-chamber bags or powder-liquid multi-chamber bags, due to the low barrier of contact packaging of these products, in order to ensure the product can block oxygen and water vapor. Infiltration, a protective barrier is required in the inner packaging (contact packaging) to block the penetration of oxygen and water vapor. In addition, in the production process, it is necessary to replace the air between the inner bag and the barrier bag by using a nitrogen displacement packaging machine, so in addition to testing the oxygen permeation amount, the nitrogen permeability and the water vapor are tested in the barrier property test. Throughput and other indicators. Labthink's VAC-V series of four differential pressure gas permeameters can perform the corresponding indicators.
Â Â Â Â Â The application of multi-chamber bags is a major improvement in the function of infusion soft bags. As one of the strict packaging requirements of pharmaceutical packaging, its testing indicators such as tensile strength and elongation, heat sealing strength, film puncture performance, rubber stopper Puncture force, sealing and other quality indicators are also required to be tested. Labthink is an excellent provider of inspection instruments and inspection services. For many years, Labthink has been providing excellent quality control solutions for the global pharmaceutical industry. I hope to have more extensive exchanges and cooperation with enterprises and institutions in the pharmaceutical industry . Â For details, please call: Guo Sijia gz@
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