Important requirements when validating sterilizing grade filters -- ComplianceOnline Biotechnology T (Biotechnology Traini)
Venue: Online Event
|Event Date/Time: Dec 02, 2010||End Date/Time: Dec 02, 2010|
Sterilizing grade membrane filters are used in many applications within the biopharmaceutical industry, most critically though as a point-of-use filter before the filling process. These filters require appropriate process validation to verify the filter performs as specified, for example retaining microbial contaminants and/or avoiding release of leachables or particulates.
In this webinar multiple validation process steps will be described and discussed in regard to methodology and criticality. These validation processes include, viability, product bacteria challenge testing, extractable/leachables testing, unspecific adsorption, particle release, chemical compatibility and product wet integrity testing.
Areas Covered in the Seminar:
What is filter qualification, what is filter validation.
Regulatory requiremnents validating sterilzing grade filters.
Various validation requirements and processes.
Practical experiences with filter validation.