This course discusses the USP Package Integrity Evaluation <1207> series of general chapters.

This course will focus on the practical aspects of various Container Closure Integrity (CCI) test technologies in the overall context of sterility assurance and provides a systematic approach to the selection and application of these leak test technologies throughout the drug product lifecycle.

Subject area:
Drug Products & APIs

Objectives (If applicable):
– 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 technologies and their practical applications.
– Define CCI test method development and validation approaches and best practices.

Target Audience (If applicable):
Parenteral drug packaging engineers and formulation scientists.
Laboratory scientific staff and managers.
Parenteral manufacturing staff.
Sterility quality assurance staff.
Regulatory affair scientists.
Pharmaceutical packaging component manufacturing staff.