Inspection

1. New Guidelines For Container Closure Integrity Testing 12/20/2018

   Increased regulatory scrutiny and exciting new analytical technologies have altered the landscape of container closure integrity testing. In order to provide guidance to this new environment the US Pharmacopoeia revised Chapter <1207> Sterile Product Package Integrity.  View this webinar recording to learn about the new guidelines and how they will impact your approach to sterile product package integrity.

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. 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.

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. Protecting Oxygen Sensitive Formulations Throughout Product Life Cycle 5/19/2021

   This webinar reviews how oxygen levels in finished parenteral drug containers can be determined and controlled throughout the product life cycle by using laser-based headspace analysis.

6. 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.

7. 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.

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.

9. 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.

10. 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.