Container Closure Integrity Testing of Auto-Injectors

Container Closure Integrity Testing of Auto-Injectors

Comparing Capillary and Laser-Drilled Hole Positive Controls

Container closure integrity, or CCI, is a critical performance characteristic for sterile drug products. As biologics and complex formulations continue to expand across pharmaceutical pipelines, auto-injectors are increasingly used to support accurate dosing and patient self-administration. While these systems improve usability and patient compliance, they also introduce added complexity for CCI testing due to limited access to the primary container once assembled.

Compromised CCI can lead to microbial contamination, loss of sterility, oxidation, or evaporation, all of which may render a drug product unsafe or ineffective. To address these risks, manufacturers must implement well-justified CCI strategies throughout the product lifecycle, supported by appropriate methodology selection and positive control design.

What This Whitepaper Covers

This whitepaper examines key technical and regulatory considerations for container closure integrity testing of auto-injectors, including:
  • Common challenges associated with testing assembled and partially assembled auto-injector systems
  • An overview of probabilistic and deterministic CCI methodologies
  • Regulatory expectations outlined by USP <1207>, FDA guidance, and industry publications
  • A comparison of capillary-based and laser-drilled hole approaches for positive control creation
  • Practical considerations related to defect representativeness, reusability, cost, and operational risk

Download the Whitepaper

Access the full whitepaper to explore detailed comparisons of capillary-based and laser-drilled hole positive controls and gain insight into selecting appropriate container closure integrity testing strategies for auto-injector systems.
Smithers-Container-Closure-Integrity-Testing-in-Auto-Injectors-2026
Smithers-Container-Closure-Integrity-Testing-in-Auto-Injectors-2026
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