Container closure integrity (CCI) ensures sterility and preserves the headspace gas of parenteral drug products. More than six product recalls have been issued over the past four years due to lack of sterility assurance and CCI failures from loose vial seals. Despite rigorous process development and validation, CCI related product recalls are still common, directly resulting from reactive, rather than proactive, control strategies.

Proactively mitigate risk to selecting your drug product vial system

Proactively mitigate risk to selecting your drug product vial system

Female patient in hospital room with medicine vials on tray
Container closure integrity (CCI) ensures sterility and preserves the headspace gas of parenteral drug products. More than six product recalls have been issued over the past four years due to lack of sterility assurance and CCI failures from loose vial seals. Despite rigorous process development and validation, CCI related product recalls are still common, directly resulting from reactive, rather than proactive, control strategies.

In this whitepaper, we will discuss:

Read time :  Importance of Container Closure Integrity with Vial systems 15 minutes

CCI- Regulatory Expectations for Pharmaceutical PackagingRegulatory Expectations for Pharmaceutical Packaging

Drug Recalls associated with Container Closure IntegrityRecalls associated with Container Closure Integrity

DeltaCube QbD Approach to Package Development and SelectionQbD Approach to Package Development and Selection

Data Driven Component Selection with DeltaCubeData Driven Component Selection

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Proactively mitigate risk to selecting your drug product vial system