Inspection

  1. 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.

  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. 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.

  5. 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.

  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. Important Considerations When Evaluating Manual vs. Automated Vision Inspection Systems 3/31/2020

    This webinar takes a look at the pros and cons of manual visual inspection. Join us in taking a deeper dive into this probabilistic test method.

  8. 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.

  9. Design, Statistical Tools For Package Integrity Testing Systems 3/26/2020

    This short podcast focuses on experimental design and statistical tools we use with non-destructive package integrity test systems that produce reliable and robust quantitative test data.

  10. 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.