05.04.23 -- Containment Considerations As You Develop Your Drug Product

Review the chapter that address container closure integrity (CCI): USP <1207> Package Integrity Evaluation – Sterile Products. Understand test methods selection and validation, different types of probabilistic methods, and package seal quality test methods.

Container closure integrity (CCI) is essential to protect the drug product through shelf life and to demonstrate an integral system to regulatory agencies. A proper risk-based approach enables the creation of a robust data file that can assist in the timely approval of regulatory applications.

A biotech that manufactures injectable large molecules was seeking to evaluate elastomeric components that would help them attain the highest quality standards for manufacturing lines. The company was keen to learn how a supplier’s tight packaging specifications could help.

Drug product containment systems comprising Daikyo Crystal Zenith® cyclic olefin polymer (COP) vials, matched with NovaPure® stoppers, offer container closure integrity (CCI) performance that has been quantified for oxygen and carbon dioxide, and they have excellent system performance. 

Vial containment systems with NovaPure® elastomer stoppers offer substantial performance benefits with their enhanced dimension control, reduced particle levels, inspection of every stopper, and use of FluroTec® film. Explore the performance of the film and why NovaPure stoppers should be the choice for sensitive drug products.