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Jinan Zhuyan Instrument Equipment Co., Ltd
Introduction to the integrity testing technology of pharmaceutical packaging containers using vacuum attenuation method sealing tester
Date: 2024-11-13Read: 6
The container sealing of packaging materials that come into direct contact with drugs should be able to ensure that the packaging system of drugs achieves a closed or sealed effect, in order to prevent contamination or loss of drug content. With the inclusion of packaging integrity throughout the product lifecycle in the United States Pharmacopeia (1207), the application of sealing and testing methods for packaging containers is increasing day by day. The vacuum attenuation method sealing tester we reasonably mentioned is a quantitative instrument for detecting the sealing of packaging containers.
Container Closure Integrity (CCI) refers to the absence of drug leakage, which may pose a risk of allowing contaminants to enter or causing drug loss. Its broad definition is: the ability of a container to prevent the loss of its contents and external contamination. The maximum allowable leakage limit is the minimum leakage rate that poses a risk to drug quality and is the basis for determining the integrity of the packaging container system; It is a work that runs through the entire product lifecycle, including the stages of product development, production, and stability research.
MLD-10 Micro Leakage Sealing Tester Vacuum Attenuation Method
In theory, the integrity of packaging containers is applicable to all drug formulations, and all drug packaging containers or packaging systems must prevent leakage or spillage of contents. However, due to the high risk of injections and the diversity and complexity of injection packaging, injection drugs have stronger applicability to container integrity and higher requirements compared to other dosage forms. For injection packaging containers, the loss of drugs includes vacuum loss, inert gas or solvent vapor loss, and microbial contamination should be prevented. The vacuum decay leak detector can effectively detect microbial invasion into the leak hole, with a detection rate of up to 100%, making it a deterministic detection method.
Jinan Zhuyan Instrument focuses on the research and development of packaging container integrity testing, testing methods, and verification related technical content. Focusing on the theoretical research of packaging container integrity testing, the company clearly recognizes that packaging container sealing testing is a part of drug stability research and a prerequisite for drug sterility testing, but it cannot replace drug sterility testing. Aseptic testing of drugs is not an effective measure of packaging integrity, as such testing cannot guarantee the integrity of packaging within the drug's shelf life.
The verification of the integrity of packaging containers must be able to prove that there is no microbial invasion, or that appropriate techniques can be used to ensure that the necessary chemical or physical properties of the drug have not undergone significant changes. The vacuum attenuation method uses non-destructive testing, and samples tested with a micro leak sealing tester can also be verified by microbial invasion method. However, vacuum attenuation method is an efficient and fast detection method, and in terms of efficiency, microbial invasion method is incomparable. Therefore, this method is recommended, especially for non-destructive testing of drug packaging.
Jinan Zhuyan Instrument focuses on the research and development of testing instruments for pharmaceutical packaging materials, proficient in the application of vacuum attenuation detection technology, and has developed the MLD-10 micro leak sealing tester based on this theory. This instrument is simple and efficient, and helps to promote the development of packaging integrity testing technology.