Validation of Alternative Microbiological Methods
ISPE - International Society for Pharmaceutical Engineering D/A/CH e.V. · Dr. Jürgen Illerhaus
25/03/2026, 16:30 · Room 6 · DE
Alternative methods for microbiological monitoring offer enormous advantages compared to the traditional plate count test. However, none of these alternative methods have yet been validated for pharmaceutical water. In this presentation, we will show you all procedures and approaches required for successful validation.
Once validation is successfully completed, alternative methods can be used not only for in‑process control but also for quality control. This makes it possible for the first time to perform fully automated quality control without any manual processes. As a result, release processes can be accelerated, and the quality of pharmaceutical water can be sustainably improved.Agenda
- Regulatory requirements
- Validation with practical examples
- Regulatory approval of alternative microbiological methods
- Automation as a key to data integrity