Container closure integrity (CCI) is a critical quality attribute for finished sterile drug products. The new EU GMP Annex 1 contains new requirements for the container closure of sterile pharmaceutical products. These requirements have triggered new best industry practices in the area of container closure integrity.
In this webinar, the featured speaker will review the new requirements and describe a practical road map enabling compliance:
- Implement a deterministic analytical method for container closure integrity testing
- Methods based on laser-based headspace analysis enable the generation of robust science-based packaging data during the product life cycle as required by the new Annex 1
- The execution of packaging studies which demonstrate the achievement and maintenance of good container closure, and enable the design of an appropriate testing strategy
Join this webinar to understand how a holistic science-based approach can be used to assure the container closure integrity of sterile drug products and comply with new regulations.
Derek Duncan, PhD, Director, Lighthouse Instruments
Dr. Derek Duncan began his career at the Dutch Institute for Atomic & Molecular Physics in Amsterdam. He moved into industry holding product & application development positions. Currently at LIGHTHOUSE since 2003, Dr. Duncan is responsible for developing applications for process monitoring and finished product inspection. These include using headspace analysis for 100 percent container closure integrity testing, lyo chamber moisture mapping and automated media fill inspection.
Who Should Attend?
- Manufacturing representatives responsible for compliance to the EU GMP Annex 1
- QC representatives responsible for container closure integrity testing
- Packaging and process development representatives
What You Will Learn
- Learn how to interpret the new container closure requirements in the new EU GMP Annex 1
- Understand how to develop deterministic analytical methods for container closure integrity testing
- See examples of design packaging studies that generate robust science-based data demonstrating good container closure integrity
LIGHTHOUSE is the leading global provider of laser-based headspace analysis systems and measurement services. Headspace applications include container closure integrity testing, monitoring of headspace oxygen during filling and for stability studies, water activity determination, lyo cycle optimization and chamber moisture mapping, and automated media fill inspection. LIGHTHOUSE offers a range of benchtop and in-line platforms with patented laser sensor technology commercialized with the help of funding from the Food and Drug Administration. In addition, analytical services are delivered from laboratory facilities in Amsterdam and Charlottesville, Virginia and include method development and analytical process and product studies.