Blister packaging sealing performance monitoring program - Database & Sql Blog Articles

**Abstract:** Blister packaging is a type of packaging formed by combining a plastic rigid sheet with a medicinal aluminum foil through a heat-sealing process. The sealing performance of blister packages is a critical factor that directly affects the quality and shelf life of the packaged medicine. This article introduces the use of the MFY-01 seal tester, independently developed by Jinan Languang Electromechanical Technology Co., Ltd., to evaluate the sealing integrity of blister packages. It explains the working principle of the equipment, outlines the testing procedure, and provides insights into how this technology can help companies monitor and improve their packaging processes effectively. **Keywords:** blister packaging, PTP packaging, pharmaceutical packaging, sealing performance, seal tester, gas leakage, bubble test **1. Introduction** In today’s competitive pharmaceutical market, blister packaging has become a popular choice due to its excellent protective properties, user-friendliness, and lightweight design. Also known as PTP or blister packaging, it consists of two main components: a rigid plastic blister and a medicinal aluminum foil. During the packaging process, the medication is placed into the plastic blister and then sealed with the aluminum foil to create an individualized, independent compartment. Since each blister is isolated, any damage to one does not necessarily affect the others. Therefore, ensuring the sealing integrity of each blister is crucial. Poor sealing can allow moisture, oxygen, and other gases to enter, leading to drug degradation, discoloration, or loss of potency. **2. Standards** Currently, the standard for testing the sealing performance of blister packages is GB/T 15171-1994, which outlines the method for evaluating the sealing performance of flexible packaging materials. This standard is widely used in the pharmaceutical industry to ensure product safety and quality. **3. Test Samples** The study involved testing a sample of granular medication packaged in blister packs, focusing on the sealing integrity of the packaging. **4. Testing Equipment** The Labthink MFY-01 seal tester was used to conduct the sealing performance tests. This device is specifically designed for checking the integrity of various types of packaging, including blister packs, bottles, tubes, and more. **4.1 Working Principle** The MFY-01 seal tester operates based on the differential pressure method. During the test, the sample is submerged in water inside a sealed chamber. A vacuum is applied, creating a pressure difference between the inside and outside of the package. If there is a leak, air will escape from the package, forming bubbles in the water. The presence and location of these bubbles indicate the sealing performance of the sample. **4.2 Application Scope** This equipment is suitable for a wide range of industries, including food, pharmaceuticals, medical devices, and electronics. It can test the sealing performance of various packaging materials such as glass, plastic, and metal. It also complies with international standards like GB/T 15171 and ASTM D3078. **4.3 Technical Parameters** - Vacuum range: 0 ~ -90 kPa - Chamber sizes: 270 mm (diameter) × 210 mm (height), 360 mm × 585 mm, 460 mm × 330 mm - Digital preset vacuum and hold time for accurate results - Automatic constant pressure system ensures consistent testing conditions - Professional software supports automatic unloading and test termination **5. Testing Procedure** 1. Submerge the blister pack sample in water within the sealed chamber. 2. Close the lid and ensure no air leaks. Set the desired vacuum level and hold time via the control interface. 3. Activate the vacuum pump and start the test. 4. Observe the surface of the sample during the vacuum process. If bubbles appear, record the pressure at which they occur and the location. If no bubbles are observed, the sample is considered to have good sealing. **6. Test Results** A total of five blister samples were tested. All showed some degree of leakage, primarily along the heat-sealed edges. The leakage occurred at pressures ranging from -31.5 kPa to -43.1 kPa. One sample remained intact even under the maximum vacuum of -90 kPa, indicating strong sealing performance. **7. Conclusion** Sealing performance is a key factor in the quality of blister packaging. The MFY-01 seal tester provides a reliable and efficient way to evaluate this performance. By identifying weak points in the packaging, manufacturers can improve their production processes and enhance product safety. To further streamline testing, Labthink has developed the i-Process 6200 seal tester and data management system, offering automated testing, real-time data collection, and secure storage for better traceability and control. **Additional Notes:** Besides sealing performance, factors such as heat seal strength, water vapor permeability, and oxygen transmission rate also play a vital role in maintaining the quality of pharmaceutical products. For more information on related testing equipment, feel free to reach out. The more you know, the more confident you’ll be in your choices. Labthink looks forward to building stronger partnerships and technical collaborations with industry professionals.

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