Newsletter | May 3, 2023

05.03.23 -- Containment Considerations As You Develop Your Drug Product

Navigating Testing For Parenteral Packaging And Delivery Systems

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.

A Risk-Based Approach To Ensure Drug Product Quality

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 Proactive Approach To Reducing Particulate Risk

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.

How To Address Challenges In Oncology Drug Containment

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. 

Finding The Right Choice For Oncology Drugs

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.

Upcoming Webinar


Join our upcoming webinar, where we will review:

  • new changes in medical device regulations,
  • the impact to integral combination products, such as prefilled syringes, and
  • the value of the technical document package to support EU filings.

Register for Webinar