Featured Articles

  1. Packaging/Delivery System Integrity And Self-Sealing Capacity Of Vial Systems

    Review the scope and testing procedures required by General Chapter USP <382> Elastomeric Component Functional Suitability in Parenteral Product Packaging/Delivery Systems.

  2. NovaPure Stoppers - 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.

  3. Have You Selected The Right Stopper For Your Lyophilized Drug Product?

    Component selection is a complex process. Packaging considerations should occur concurrent with drug development to mitigate risk at every step of the drug development process.

  4. Successful Industrialization Requires Solid Foundations

    Learn how choosing the appropriate quality of containment systems from the outset is critical to the successful industrialisation of an injectable drug product and review some of the associated challenges.

  5. Build A Vial-Stopper Combination Suitable For Drug Product Storage At -80°C

    This study worked to determine if the chosen vial-stopper-seal combination will remain integral while frozen at -80°C, under studied conditions, when the appropriate materials, processing, and sealing conditions are applied.

  6. Demystifying Performance Testing: Strategies To Qualify Combination Products

    Explore applicable regulations and guidances, and performance risks identified using failure modes and effects analyses (FMEA) and failure cause mapping analyses.

  7. Addressing Glass Particulates In Injectable Drug Formulations

    Learn how a new vial design that is capable of reducing the propensity for glass particulate generation on filling lines is enabling a significant, positive impact on product quality and safety.

  8. Key Considerations For Selecting Fill/Finish Manufacturing Technologies

    Obtaining information and proactively mapping out your fill/finish strategy early can de-risk an investment in equipment or processes, ensuring you meet your long-term needs.

  9. Control Strategy Factors For Drug-Device Combination Products

    Building a control strategy comprises understanding the connectivity among materials of composition, components, constituent parts, final drug-device combination product, and critical process parameters.

  10. Create An Effective Risk Management Program

    Drug-device combination products are rapidly increasing in use, based on their numerous benefits. This article is a review of achieving performance and regulatory compliance for their successful development and commercialization.