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    ManufacturingManufacturing & SupplyCCI

    Container Closure Integrity

    Demonstration that a sterile package maintains microbial barrier and contents integrity over the labeled shelf life.

    Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast reviewed May 5, 2026

    Definition

    CCI testing methods (dye ingress, helium leak, vacuum decay, microbial challenge) confirm that the sterile barrier system protects sterility. ISO 11607 references CCI methods; package validation must address transport hazards in addition to long-term stability.

    What this means in practice

    CCI failures are a leading cause of recalls and field corrections in sterile-packaged devices.

    Primary references

    3 sources
    Link health: 3 verified· last checked 2026-05-09
    ISO·2IMDRF/GHTF·1
    1. 1
      ISO 11607-1
      Verified
      ISOiso.org
    2. 2
      ISO 13485 Standard Page
      Verified
      ISOiso.org
    3. 3
      GHTF/IMDRF Process Validation Guidance
      Verified
      IMDRF/GHTFimdrf.org

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