Validating Automated Alternative Rapid Sterility Methods

Learn how Rapid Micro Biosystem validated an automated, growth-based rapid sterility method using an on-site validation approach to demonstrate equivalency (or non-inferiority) versus the compendial sterility test described in the pharmacopeia. You’ll see how automation can simplify sterility workflows while supporting regulated QC expectations.

What you’ll learn

In this webinar, you’ll get:

• An overview of the Growth Direct® Rapid Sterility System and how it compares to the compendial sterility test, including the “why” behind the system design and how automation simplifies workflow.
• A practical review of validation criteria for alternate qualitative methods, with discussion of case studies, rapid sterility examples, and relevant industry guidance.
• A clear foundation in sterility testing, including how automation can help your workflow and how alternate growth-based methods can be validated.

Who should register

This webinar is designed for:

• Microbiologists
• QC Directors/Managers
• Pharmaceutical & biologics manufacturers
• Cell & gene therapy manufacturers and QC teams