Event
This course discusses the USP <1207> series of general chapters, which will focus on theoretical and practical aspects of various Container Closure Integrity (CCI) testing technologies in the overall context of sterility assurance and provides a systematic approach to applying these testing methods for CCI verification throughout drug product lifecycle.
Upon completion of this course, you will be able to:
- Describe <1207> recommendations on CCI.
- Define CCI requirements for various container and drug product types using a risk-based approach.
- Explain principles of various CCI testing techniques and their practical applications, focusing on deterministic methods such as tracer gas detection (e.g. helium leak detection), electrical conductivity and capacitance (HVLD), vacuum decay leak detection, laser based gas headspace analysis and mass extraction leak test.
- Define CCI testing method development and validation approaches and best practices.
Who Should Participate:
- Parenteral drug packaging engineers and formulation scientists
- Laboratory scientific staff and managers
- Parenteral manufacturing staff
- Sterility QA staff
- Regulatory affair scientists
- Pharmaceutical packaging component manufacturing staff