Container Closure System容器密封系统
A container closure system is the combination of packaging components that contains, protects, and delivers a drug product, including primary containers such as vials, stoppers, seals, caps, and any secondary protective elements. In pharmaceutical development and regulatory submission documents, it is described for compatibility, integrity, and manufacturing control to ensure product stability and patient safety.
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Where this term appears
In translation and localization, container closure system descriptions appear in drug product dossiers, extractables and leachables reports, stability studies, and artwork specifications. Translators often work on sections describing primary packaging materials, closure types, and storage conditions across multiple markets.
Translation checks
A common error is translating “closure” as “closing” or “sealing process” rather than a physical component like a stopper or cap, which distorts intended meaning. Another is omitting the distinction between primary and secondary packaging, which can affect the interpretation of drug contact and leachables risks.
Keep the term aligned across your files
Check intended use, warnings, document versions and approved terminology with the project team. Translation supports documentation; it does not establish product approval or regulatory acceptance.
Provide approved terms and previous translations with the source files. Agree how variants, ambiguous wording and revisions will be reviewed. Terminology maintenance and any termbase handback are confirmed in the project scope. See the 8-step AI + expert workflow.
Related document experience
NIPRO Medical (Hefei)
Chinese → EnglishMedical-device registration files and technical specifications, in volume.
Read the published project →
Walvax Biotechnology
Chinese → EnglishQuality manuals, SOPs, production-process and clinical-trial documentation.
Read the published project →Published scope shows related industry experience; it does not confirm that this specific term was used or reviewed in the project.
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Include the source and target languages, file types, intended use, deadline and any approved termbase. Agree handling before sending sensitive files. Acknowledged in 4 hours, quoted in 24.
Prepare an inquiry email →Life Science solutions →File handling →A glossary entry is not an official standard or evidence of regulatory acceptance. Confirm current requirements for your project separately.