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Abstract: Blister packaging is a type of packaging formed by combining a rigid plastic sheet with a medicinal aluminum foil through a heat-sealing process. The sealing performance of blister packages is a critical factor that significantly affects the quality and stability of the packaged medicine. This article introduces the use of the MFY-01 seal tester, developed independently by Jinan Languang Electromechanical Technology Co., Ltd., to evaluate the sealing integrity of blister packages. It explains the working principle of the equipment and outlines the testing procedure, providing valuable guidance for enterprises in monitoring the quality of their packaging solutions.
Keywords: blister packaging, PTP packaging, medical packaging, sealing performance, seal tester, gas leak, moisture barrier
1. Introduction
Blister packaging has become a popular choice in the pharmaceutical industry due to its excellent protective properties, ease of use, and lightweight design. Also known as PTP or blister packs, this packaging method typically consists of a rigid plastic blister and a medicinal aluminum foil. During the packaging process, the medicine is placed into the plastic blister and then sealed with the aluminum foil, creating individual compartments. If one compartment is compromised, it should not affect the integrity of the others. Therefore, ensuring the sealing quality of each blister is essential to prevent contamination, moisture ingress, or degradation of the product.
2. Standards
The primary standard used for evaluating the sealing performance of blister packages is GB/T 15171-1994, which outlines the test methods for flexible packaging. This standard applies to various materials and provides a reliable reference for manufacturers.
3. Test Samples
In this study, a brand of granular medication was packaged using blister packs for evaluation.
4. Testing Equipment
The MFY-01 seal tester, produced by Labthink, was employed to assess the sealing performance of the blister samples.
5. Test 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, bubbles will appear on the surface of the sample. Alternatively, visual inspection of the sample's shape recovery after vacuum release can also indicate the sealing integrity.
6. Application Scope
This equipment is suitable for testing the sealing performance of various types of packaging, including bags, bottles, tubes, cans, and boxes, across industries such as food, pharmaceuticals, medical devices, and electronics. It complies with international standards like GB/T 15171 and ASTM D3078.
7. Equipment Parameters
- Vacuum range: 0 ~ -90 kPa
- Chamber sizes: 270 mm × 210 mm, 360 mm × 585 mm, 460 mm × 330 mm
- Digital preset vacuum and hold time
- Automatic constant pressure air supply
- Professional software for automated testing and data management
8. Test Procedure
1. Submerge the blister pack in a sealed tank filled with water.
2. Seal the tank and set the desired vacuum level and hold time via the control panel.
3. Activate the vacuum pump and start the test.
4. Observe for bubble formation on the sample’s surface. Record the pressure at which leaks occur. If no bubbles are observed, the sample is considered well-sealed.
9. Test Results
Five blister samples were tested. Four showed leakage at different pressures (-31.5 kPa, -26.9 kPa, -43.1 kPa, and -70.0 kPa), while one sample remained intact under the maximum vacuum of -90 kPa.
10. Conclusion
Sealing performance is a crucial factor in blister packaging. The MFY-01 seal tester offers an efficient way to evaluate and improve packaging quality. To enhance accuracy and data management, Labthink has developed the i-Process 6200 seal tester and data processing system, which automates the testing process and enables real-time data tracking. This helps ensure consistent quality control on the production line and supports long-term traceability.
In addition to sealing performance, other factors such as heat seal strength, water vapor permeability, and oxygen transmission rate also influence the quality of pharmaceutical packaging. For more information on related testing equipment, feel free to explore our website or contact us directly. We look forward to building stronger technical partnerships with industry stakeholders.
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