Package integrity is the absence of gaps/breaches in packages that could risk product quality by allowing contaminant ingress and/or product loss. Although parenteral packages must keep products sterile, package integrity is not defined as absence of microbial or liquid ingress nor product sterility.
Package integrity verification requires careful examination of package leakage given the specific product and its life cycle. DDL’s CCI services cater to the pharmaceutical and biotech companies along with their respective medical device manufacturers with the most recent deterministic capabilities. We can provide tailored expertise to design and execute a CCI study based on your system, providing the support you need.
CCI method selection depends upon the container system being evaluated; a single method is not suitable for all systems. Our experts can assist you with the determination of the right test method for your system.
USP 1207 Package Integrity Evaluation-Sterile Products
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