Inspection

  1. Rapid Non-Destructive Product Moisture Determination In Stability Studies 2/17/2022

    Examine whether Karl-Fischer (KF) titration can be replaced by rapid, non-destructive lyo product moisture determination method.

  2. Early-Stage Considerations For The Selection Of Pre-Fillable Syringes When Developing A Vaccine 5/14/2021

    Get an overview of the strategy to speed up the migration from a vial to a pre-fillable syringe. Explore the main considerations in meeting and overcoming PFS-drug challenges when developing a vaccine.

  3. The Container Closure Integrity Requirements In The Revised EU Annex 1

    Learn about the advantages and disadvantages of CCI testing methods, how the revised EU Annex 1 may impact your strategy for ensuring CCI of sterile pharmaceutical products, and more.

  4. USP <922> Water Activity Has Opened A Door For OSD Manufacturers 6/20/2022

    Learn more about USP <922> Water Activity and why using Karl-Fischer titration to measure total water content is no longer adequate to fully understand the stability of oral solid dosage products.

  5. Survival Kit For Quality Regulations: A Closer Look At Lyo Packaging

    Explore primary packaging developed following well-established ICH principles for sustainable compliance and vial container closure systems for product development and commercial manufacturing needs.

  6. A Rapid Approach For Moisture Determination Of Lyophilized Product 11/13/2024

    Explore the limitations of traditional moisture determination techniques, an innovative approach using laser-based headspace analysis, and real-world case studies using this non-destructive method.

  7. Protecting Oxygen Sensitive Formulations Throughout Product Life Cycle 5/19/2021

    This webinar reviews how oxygen levels in finished parenteral drug containers can be determined and controlled throughout the product life cycle by using laser-based headspace analysis.

  8. Container Closure Integrity Of Product Requiring Deep Cold Storage 8/26/2022

    Gain insight into the risk to container closure integrity (CCI) during deep cold storage and identify appropriate analytical tools, to generate robust data to characterize and mitigate the risk to CCI.

  9. Mitigating Ultracold Storage And Transport Risk With CCIT

    Dr. Derek Duncan, Director of Product Lines, Lighthouse Instruments, and Brandon Zurawlow, Chief Scientific Officer, CS Analytical, discuss a program for generating packaging data for deep cold storage products.

  10. A Science-Based Approach For Ensuring Container Closure Integrity Of Sterile Vials 3/15/2021

    Recent regulatory guidance has triggered changes in industry best practices in the area of container closure integrity (CCI) testing. A more science-based holistic approach that includes robust design & qualification of the process and the implementation of appropriate process controls is required. This webinar will describe a framework to enable such a holistic approach to CCI that assures both the primary packaging and the process contribute to good CCI of sterile injectable vial product.