[Chinese Packaging Network News] Blister packaging is a type of packaging formed by heat-sealing a plastic hard film and medical aluminum foil. The sealing performance of blister packaging is a critical indicator that directly affects the quality and safety of pharmaceutical products. This article introduces the use of the MFY-01 Sealing Tester, independently developed by Jinan Languang Electromechanical Technology Co., Ltd., to evaluate the sealing performance of blister packages. It explains the working principle of the equipment and outlines the testing procedure, offering valuable guidance for enterprises to monitor and improve their packaging quality.
1. **Definition**
Blister packaging has become a key component in the pharmaceutical industry due to its advantages such as excellent protection, ease of use, and lightweight design. Also known as PTP packaging, it consists of two main parts: a rigid plastic blister and a medicinal aluminum foil. During the packaging process, the medicine is placed into the blisters of the rigid sheet and then sealed with the aluminum foil, creating individual, independent compartments. If one blister is compromised, it should not significantly affect the integrity of the others. Therefore, ensuring the seal of each blister is crucial. Poor sealing can allow moisture, oxygen, and other gases to enter, potentially causing the drug to degrade or discolor.
2. **Standards**
Currently, the primary standard used for evaluating sealing performance is GB/T 15171-1994, which outlines the test method for flexible packaging. This standard applies to various materials used in sealed flexible packages.
3. **Test Sample**
The sample tested was a brand of blister packaging designed for granular pharmaceuticals.
4. **Testing Equipment**
The MFY-01 Sealing Tester from Labthink Blue was used for this test.
4.1 **Testing Principle**
The device operates based on the differential pressure method. During the test, the sample is submerged in water inside a sealed chamber. A vacuum is created, resulting in a pressure difference between the inside and outside of the sample. If the seal is weak, gas may escape through the leak points, forming bubbles in the water. Alternatively, the expansion and recovery of the sample after releasing the vacuum can also be observed to determine the sealing quality.
4.2 **Application**
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, daily chemicals, automotive, electronics, and more. It is compatible with different materials like glass, plastic, and metal.
4.3 **Equipment Parameters**
- Vacuum range: 0 ~ -90 kPa
- Three available chamber sizes: 270 mm (diameter) × 210 mm (height), 360 mm (diameter) × 585 mm (height), 460 mm (diameter) × 330 mm (height)
- Digital preset vacuum and time settings ensure accurate results
- Automatic pressure compensation ensures consistent testing conditions
- Professional software supports automatic unloading and test end functions
5. **Testing Procedure**
(1) Submerge the blister pack sample in water within the sealed chamber.
(2) Close the lid securely and set the required vacuum level and holding time via the control interface.
(3) Start the vacuum pump and initiate the test.
(4) Observe the sample for any continuous bubbles during the vacuum phase. Record the pressure and location if bubbles appear. If no bubbles are observed, the sample is considered well-sealed under the set conditions.
6. **Test Results**
Five blister samples were tested. All five showed leakage, with four leaking at the heat-sealed edges at pressures of -31.5 kPa, -70.0 kPa, -26.9 kPa, and -43.1 kPa. One sample remained leak-free even at the maximum vacuum of -90 kPa, indicating good sealing performance.
7. **Conclusion**
Sealing performance is a critical factor in blister packaging. The MFY-01 Sealing Tester is a reliable tool for assessing sealing quality, providing both quantitative and qualitative insights. To address limitations of manual data recording, Labthink developed the i-Process 6200 Sealing Tester and Data Processing System, which automates testing, data collection, and analysis. This system improves efficiency, reduces errors, and enhances traceability.
In addition to sealing performance, factors such as heat seal strength, water vapor transmission rate, and oxygen permeability also influence drug quality. For further information on testing these properties, feel free to explore our resources. The more you know, the more confident you’ll be. Labthink looks forward to collaborating with industry partners to advance technical exchanges and innovation!
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