Analysis and Test of Multi-Chamber IV Bag Seal Strength and Barrier Performance

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At present, there are two types of multi-chamber large volume IV bags, one is liquid-liquid multi-chamber bags, the other is powder-liquid multi-chamber bags: it refers to that different IV drugs are packed in the same package in the production process, storage and transportation process, separated in different chambers by sealing, the seal is opened by external force and the drugs are mixed before clinical use. Multi-chamber IV bag products are mainly suitable IV solutions which are unstable after preparation and cannot be stored for a long time. This paper only analyzes two key quality factors of the multi-chamber IV bags, namely the seal strength performance and the barrier performance.

1、 Seal strength analysis and detection

For both liquid-liquid and powder-liquid multi-chamber bags, the seal strength must ensure the convenience and safety of clinical use and the separation efficiency of the product in storage and transportation, so the sealing process control of multi-chamber bag is a key step in the whole production process. The seal strength performance mainly depends on the temperature, time and pressure. How to control this factor has become a concern of the multi-chamber IV bag manufacturers.

Labthink HST-H3 heat sealing tester and XLW (PC) intelligent auto tensile tester are used for the detection of this factor in multi-chamber IV soft package. When the finished multi-chamber bag is tested, the sample is directly cut from the sealing side, and then the test can be automatically completed by selecting the “heat sealing strength” test item on XLW (PC) auto tensile tester. In addition, as an IV bags manufacturer, in order to pursue the appropriate strength of the sealing, it is often necessary to study the heat sealing temperature, time and pressure, these parameters can be analyzed with the help of HST-H3 heat seal tester.

2、 Analysis and test of barrier performance

Barrier performance is an important factor affecting the quality of multi-chamber bags. No matter the liquid- liquid multi-chamber bags or powder-liquid multi-chamber bags, contact packaging usually has low barrier performance, in order to ensure barrier of oxygen and water vapor, it is necessary to add another layer of barrier packaging to the inner packaging (contact packaging) to block the permeation of oxygen and water vapor. In the production process, nitrogen is used to replace the air inside the packaging, therefore, in addition to the oxygen barriers performance, the nitrogen permeability and the water vapor permeability should also be tested. The machine displaces the air between the inner bag and the barrier bag. Therefore, in the barrier test, in addition to the test of oxygen transmission, the test of nitrogen transmission, water vapor transmission and other indicators are also required. Labthink VAC series differential pressure gas permeability testers can complete the corresponding test items.

The application of multi-chamber IV bag is a significant improvement of the function of IV bag. As one of the packaging forms with most strict requirements for medicine, its testing indicators such as tensile strength and elongation, heat sealing strength, film puncture resistance, rubber plug puncture force, sealing and other quality factors need to be tested. As an excellent provider of testing instruments and testing services, Labthink has been continuously providing comprehensive quality control solutions for the global pharmaceutical field for many years. We look forward for more exchanges and cooperation with enterprises and institutions in the pharmaceutical industry.