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It is clear that the market, in general, is still trying to understand how to manage these new expectations, and manage the optimization and qualification of vial containment systems. In particular, “change management” is a challenge – 65% of respondents have not upgraded to the more sensitive and deterministic analytical techniques promoted in Chapter <1207>, but still reply upon probabilistic methylene blue dye ingress.
In order to achieve a better understanding to address these challenges, and others in CCI, see A Holistic Strategy for Container Closure Integrity: Selecting and Evaluating an Integral Packaging System, PDA Journal of Pharmaceutical Science and Technology 72 (1), 15-34 (January-February 2018). Visit the West Knowledge Center, which houses various materials on the subject, or contact a Technical Customer Support representative for more information.