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. 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.

3. 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.

4. 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.

5. 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.

6. Container Closure Integrity Testing Method Development

   Dr. Derek Duncan, Director of Product Lines, Lighthouse Instruments, covers approaches that can be used for method development for CCI testing in all phases of the product life cycle.

7. 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.

8. 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.

9. USP <922> Water Activity Testing For Oral Solid Dose Pharmaceuticals 8/26/2022

   Gain insight into the technical and regulatory justification for adding water activity measurements into pharmaceutical stability protocols.

10. 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.