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. 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.

  3. The Importance Of Package Integrity To Shelf Life Of Products 4/1/2020

    This video discusses the importance of protecting package contents from contaminants, including challenges associated with transport and specifically how altitude and latitude affect packaging formats.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. The Sensitivity Trap: Building Confidence In CCIT Performance 3/2/2026

    Effective CCIT goes beyond micron claims, focusing instead on repeatability, confidence, and real‑world relevance. Learn how to define a defensible LOD and understand what auditors truly prioritize.

  9. 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.

  10. Scalable Solutions for Container Closure Integrity Testing 7/12/2022

    Learn alternative technology options and data integrity compliance capabilities that are critical to CCIT due to a wide variety of applications and regulatory requirements.