Container closure integrity (CCI): Response to the publication of USP<1207>

USP published its revised and expanded guidance, USP<1207>, in 2016 ostensibly asking as many questions as it answered.

Specifically, USP<1207> implies ’probabilistic’ tests such as the ubiquitous dye ingress method are inferior and proposes a preference for so-called deterministic tests. The added assertions that deterministic methods can achieve high levels of sensitivity and accuracy do not reflect the ‘real world’ experience of the industry’s CCI experts whose work with the newer methods highlight a range of improvements that must be addressed before such claims can feature in guidance.

This paper makes the distinction that any method – probabilistic or deterministic – when properly validated may be regarded as acceptable, with no one method type worthy of a preferred status.

This deliverable has been published via the BioProcess International website.

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