Inspection

  1. A Data-Driven Approach To Container Closure Integrity

    Gain confidence in your container closure system selection by utilizing a stepwise and data-driven approach to predicting and verifying container closure integrity.

  2. 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.

  3. 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.

  4. 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.

  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. Replacing Total Moisture Measurements By Water Activity Determination 4/19/2022

    This short video explains the difference between total moisture content, headspace moisture, and the relation to water activity.

  7. 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.

  8. 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.