In the pharmaceutical industry, the sealing of drug packaging is directly related to the quality of drugs and the safety of patients. Any small leakage can lead to drug contamination, reduced efficacy, or even failure, therefore, strict sealing testing of drug packaging is crucial. The micro leakage sealing tester, as a precision instrument that adopts the LEAK-S vacuum attenuation method testing principle, is becoming a testing tool for pharmaceutical manufacturers, third-party testing agencies, and drug testing agencies due to its non-destructive testing technology, high sensitivity, and wide applicability.

Testing principle: Precision detection based on vacuum attenuation method

The micro leakage sealing tester strictly follows testing standards such as ASTM F2338, USP 1207, 9628, etc., and uses vacuum attenuation method as its core testing principle. This method constructs a closed testing environment, namely a testing chamber, in which the packaging material to be tested is placed. Subsequently, the tester precisely controls the vacuum extraction of the testing chamber, creating a significant pressure difference between the inside and outside of the packaging. Under the action of this pressure difference, if there are small leakage holes in the packaging, the gas inside will slowly diffuse into the testing chamber through these holes, causing changes in the pressure inside the testing chamber.

This process is monitored and recorded in real-time by precision vacuum sensors, which can capture subtle fluctuations in pressure over time and compare these data with preset mathematical models or standard values for analysis. Through complex algorithm processing, the tester can accurately determine whether there is leakage in the packaging and the degree of leakage, thereby achieving a comprehensive evaluation of the sealing performance of the packaging.

High precision CCIT testing technology: a powerful tool for capturing small leaks

The LEAK-S micro leakage sealing tester of Jinan Sanquan Zhongshi adopts CCIT technology, which further improves the accuracy and sensitivity of detection. This technology can apply continuous and controllable small pressure pulses to the testing chamber in a very short period of time. Combined with highly sensitive vacuum sensors, it can accurately capture even tiny to micrometer sized small hole leaks, ensuring the detection of packaging sealing.

Wide applicability: covering various forms of drug packaging

The LEAK-S micro leakage sealing tester from Jinan Sanquan Zhongshi is known for its wide applicability, which can meet the sealing testing needs of various drug packaging forms, from large capacity injection solutions such as penicillin bottles and infusion bottles, to small capacity preparations such as ampoules, pre filled needles, eye drops bottles, and even freeze-dried products. This feature makes the tester an ideal choice for quality control of pharmaceutical production lines, product development verification, and compliance testing by third-party testing agencies.

Complies with international standards and regulatory requirements

This tester not only follows the ASTM F2338 standard, but also meets the relevant requirements of FDA and other institutions for drug packaging sealing testing, ensuring the accuracy and reliability of test results. For pharmaceutical companies that pursue high-quality and high standard production, this characteristic is particularly important as it helps them improve product quality and enhance market competitiveness.

The extensive applicability and strict adherence to standards of the LEAK-S micro leakage sealing tester play an irreplaceable role in ensuring the sealing of drug packaging, improving drug quality and safety.

As a professional manufacturer of packaging testing instruments, Jinan Sanquan Zhongshi Experimental Instrument Co., Ltd. closely follows the requirements of national standards and also participates in the development of some national drug packaging material standards. By utilizing our years of technical accumulation and industry application experience in the field of packaging inspection, we provide data and theoretical support for the formulation of standards, and contribute to the establishment of the national standard system.