Chemical injection packaging system sealing research technology guide
2022-06-17
I. Overview A packaging system is the sum of all packaging components that contain and protect a pharmaceutical product, including packaging components that come into direct contact with the drug and secondary packaging components. This technical guide is mainly applicable to the packaging system of chemical injection. The packaging system for injectables should be able to maintain the integrity of the product contents while preventing microbial invasion. Package integrity, also known as container-closure integrity, refers to the ability of the packaging system to prevent the loss of contents, microbial invasion, and the entry of gases (oxygen, air, water vapor, etc.) or other substances to ensure that the drug continues to meet safety and quality requirements. package integrity test , or container-closure integrity test, CCIT, is a package leak test (including physicochemical or microbiological testing methods) that detects any rupture or seam, some of which can determine the size and/or location of the leak. This technical guide is drafted with reference to relevant domestic and international technical guidelines and standards, focusing on the selection and validation of sealing inspection methods for injectable packaging systems, with the aim of facilitating the research and evaluation of chemical injectables at this stage. The drafting of this technical guide is based on the current knowledge of the issue, and will be revised and improved with the continuous improvement of relevant regulations and the improvement of technical requirements of drug research. II. General considerations The main types of leaks in injection packaging systems include: 1) microbial intrusion; 2) drug escape or external liquid/solid intrusion; and 3) change in headspace volume content, e.g., headspace inert gas loss, vacuum disruption, and/or external gas entry. The sealing quality requirements of the injection packaging system can be divided into: 1) the need to maintain sterility and product component content, without maintaining the headspace volume; 2) the need to maintain sterility, product component content and headspace volume; 3) the requirement to maintain sterility of multi-dose packaging, that is, after the package is opened, to prevent microbial invasion and leakage of drugs during use. Research related to the sealing of the injection packaging system should be carried out according to the product characteristics. Injectable packaging system sealability meets the requirements, which usually means that the packaging system has passed or can pass the microbial challenge test. A broad sense means that there are no leaks that would affect the quality of the drug product. Based on scientific studies and risk assessment, the maximum allowable leakage limits should be determined taking into account the packaging composition and assembly, the product contents, and the environment to which the product may be exposed during its life cycle. A packaging system is con...
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