How to avoid Leachables, Estractables, and Other Hazards in Parenteral Packaging

Venue: Coronado

Location: Coronado, California, United States

Event Date/Time: Jan 11, 2009 End Date/Time: Jan 11, 2009
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How to Avoid Leachables, Extractables, and Other Hazards in Parenteral Packaging
Strategies for ensuring the high standard for injectable drug packaging
This pre-conference short course is pre-cursor to the “Lyophilization 2009” conference taking place on Monday, Tuesday and Wednesday and its sister conference, “Current Trends in Dosage Form Development and Biologics Formulation: Addressing Challenges in Stability Testing, Forced Degradation, Protein Aggregation and Manufacturing,” taking place on Thursday and Friday. Attendees are encouraged to attend the workshop and stay for the entire week in order to attend both events.

Topics to be covered:

Strategies for controlling quality and minimizing risk: packaging design, integrity, and materials
Key considerations in primary packaging to ensure a parenteral product’s regulatory submission
Understanding the impact of extractables and leachables on well characterized protein products
Analysis, characterization and safety evaluation of extractables and leachables
Strategies for selection of container/closure systems
Best practices in parenteral packaging design and testing to ensure product integrity
How to avoid and control extractables and leachables at manufacturing scale
How to avoid and control extractables and leachables from dosing components
Course Instructor:
Michael Ruberto, Ph.D., Head of Regulatory, CIBA Expert Services