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. A Practical Road Map For Compliance To EU GMP Annex 1

    Learn how to interpret the Annex 1 container closure requirements, develop deterministic analytical methods for CCIT, and design packaging studies that generate robust data demonstrating good CCI.

  3. 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.

  4. 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.

  5. 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.

  6. Why Add Water Activity To The Stability Test Protocol 3/21/2022

    In this video we describe a framework on how by adding water activity measurements to stability protocols will achieve to improve the quality program.

  7. Selecting Container Closure Systems With Confidence: Lyophilization 3/7/2024

    Experts take you through the entire selection process for primary packaging components for lyophilization and provide aspects to consider for all relevant attributes.

  8. 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.