Source: Link Testing Instruments Co.,ltd.
Aluminum ointment tubes are a common pharmaceutical packaging format, widely used for semi-solid dosage forms. Their sealing performance directly impacts the quality stability and safety of pharmaceuticals. Therefore, according to the air tightness requirements of industry standard YBB00162002-2015, "Aluminum Ointment Tubes for Pharmaceutical Use," leak and seal strength testing of ointment tubes is crucial.
I. Significance of Testing
Drugs may be subject to environmental influences during transportation, storage, and use, such as temperature fluctuations, pressure, and vibration. Inadequate sealing performance of ointment tubes can lead to leakage, contamination, or deterioration of the contents, compromising efficacy and even posing safety concerns. Scientific leak and seal strength testing can effectively assess the sealing reliability of ointment tubes in practical applications, providing data support for product design optimization and quality control.
II. Testing Requirements in the Guidelines
According to standard YBB00162002-2015, aluminum ointment tubes must meet specific sealing requirements. Specific testing methods typically include negative or positive pressure testing, which involves setting a certain pressure and observing whether the sample leaks to determine whether the sealing performance meets the standard. Furthermore, the standard specifies the number of samples, test duration, and judgment criteria to ensure the scientific and consistent nature of the test results.
III. Applications of the LTMFY-06S Intelligent Sealing Tester
The LTMFY-06S Intelligent Sealing Tester, developed by Link Testing Instruments Co., Ltd., is designed and manufactured in accordance with relevant standards and is suitable for testing the seal performance of various packaging items, including ointment tubes and bottle caps. This instrument utilizes the principle of air pressure differential to automatically determine whether a leak is present by applying a set pressure to the sample and monitoring the pressure change. The device offers ease of operation, high accuracy, and excellent repeatability, making it widely used in quality inspections within the pharmaceutical industry.
Key parameters of this instrument include an adjustable test pressure range, a programmable test time, and a digital display system for real-time data monitoring and recording. Its compact design makes it suitable for routine laboratory testing.
IV. Conclusion
With the continuous improvement of pharmaceutical regulatory requirements, the sealing performance of aluminum ointment tubes has become a key quality evaluation indicator. Companies should conduct leakage and seal strength testing in strict accordance with standard requirements to ensure product compliance. Furthermore, the use of professional testing equipment such as the LTMFY-06S can improve testing efficiency and accuracy, contributing to the continuous improvement of pharmaceutical packaging quality.
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