The article is provided by Jinan Sanquan Zhongshi Experimental Instrument***.
In the pharmaceutical industry, oral solid dosage forms are common pharmaceutical dosage forms, which are typically packaged in solid dosage bottles. Although the packaging tightness requirements for oral solid dosage forms are not as stringent as for sterile injectables, good sealing is still an important factor in ensuring the quality and safety of drug products. Therefore, the national pharmaceutical packaging material standard has clear requirements for the tightness of packaging containers.
In order to meet these requirements, capsule tightness testing instruments have been developed. This instrument uses a negative pressure vacuum method to evaluate the sealing performance of the packaging container by detecting its leakage in a vacuum state. Below we will detail the principle, application, and why such an instrument is important.
1. Principle introduction
The capsule tightness testing instrument is based on the principle of negative pressure vacuuming. During the testing process, the instrument first places the packaging container to be tested in a vacuum environment, and then gradually extracts the air in the container through the air extraction system to form a certain negative pressure. If the packaging container is well sealed, the gas inside the container will be gradually pumped out without obvious leakage. On the other hand, if the container is not well sealed, the outside air will enter the container through the leakage point, resulting in the pressure in the container not being able to drop steadily or the pressure will rise.
2. Applications and advantages
Capsule tightness testing instruments are widely used in pharmaceutical, food, health care products and other industries. Its advantages are mainly reflected in the following aspects:
Rapid detection: The instrument can complete the detection of a large number of samples in a short time, which improves the production efficiency.
High accuracy: By precisely controlling the vacuum degree and detection time, the instrument can accurately judge the sealing performance of the packaging container.
Easy to operate: The instrument is simple to operate, easy to use, and reduces human error.
3. Materiality analysis
Capsule tightness testing instruments play an important role in ensuring the quality of oral solid dosage forms. First of all, good sealing can prevent the drug from moisture, oxidation or contamination, thus ensuring the effectiveness and safety of the drug. Secondly, the tightness test helps to detect possible problems in the production process in time, such as packaging material defects, improper production processes, etc., so as to take corrective measures in time to avoid the expansion of the problem. Finally, through strict tightness testing, the stability of the drug during transportation and storage can be ensured, and the shelf life of the drug can be extended.
IV. Conclusion
With the continuous development of the pharmaceutical industry, the role of capsule tightness testing instruments in ensuring the quality and safety of pharmaceutical products will become more prominent.