Case Study: Accelerating Sterility Testing with Validated Alternatives for Rapid Product Release

  • Experience validating a sterility method to support a seven-day turnaround time for product release, sharing lessons learned, challenges encountered, and key considerations for integrating rapid methods into GMP environments
  • Highlights from the implementation of a rapid mycoplasma test that delivered results within one day
  • Explore how thoughtful sampling time points and clear guidance can streamline rapid testing workflows and support consistent product quality