TR 27 defines Container Closure Integrity as the ability of a package to prevent product loss, block microbial ingress, and limit entry of harmful gases (like oxygen or moisture). The report introduced the concept that no package is perfectly sealed; rather, integrity is defined by the Maximum Allowable Leakage Limit (MALL) .
The report famously correlates leak size with microbial ingress: pda technical report 27 pdf
PDA occasionally offers free or discounted technical reports to attendees of certain training courses (e.g., “Packaging Integrity Boot Camp”). Check the event materials. TR 27 defines Container Closure Integrity as the
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TR 27’s Recommendation: Use deterministic methods whenever feasible; microbial challenge should be used only for validation of deterministic method sensitivity limits.