Rapid Microbial Methods for Pharmaceutical Water Systems - Live Online Training
29/30 September 2026
Course No. 22297
Speakers
Dr Hans-Joachim Anders
Novartis Pharma Stein
Markus Multhauf
Consultant Pharmaceutical Engineering
Dr Michael Miller
Microbiology Consultants
Dr Harmen Hawer
Panpharma
Dr Jürgen Illerhaus
BWT Aqua
Feng Jin Liew
Mettler-Toledo-Thornton
Isabel Mabrito
Mettler-Toledo-Thornton
Highlights:
- Rapid Water Monitoring Systems – Case Studies
- Validation of Alternative Methods for Microbiological Examination of Water
- Case Studies of Contamination in Pharmaceutical Water Systems without Microbial Online Monitoring
Target Group
This course is intended for professionals and staff in the fields of microbiology, quality assurance, engineering, and production who are involved in the design and microbiological control of pharmaceutical water systems.
Objectives
The aim of this event is to provide information on current applications of online microbial monitoring of pharmaceutical water and to demonstrate the state of the art. Case studies are used to demonstrate the online detection of contamination in water systems. It will also be shown how alternative methods for microbiological examination of water can be validated.
Programme
Rapid Microbial Methods for PW and WFI – Application Notes from a Technical Point of View
Regulatory Recommendations and Practical Hurdles
How to Generate a Return on Investment – Application Examples & Limitations
Remarks on Rapid Microbial Methods and At-Line Particle Measurements
Data and Studies on Drinking Water and Ultrapure Water in the Semiconductor Industry
Demonstrating Comparability and Changing Acceptance Levels for Biofluorescent Particle Counter (BFPC) Rapid Water Monitoring Systems
Understand the Difference between the CFU and New Signals from BFPC Technologies
Learn How Regulators and the Compendia Are Addressing Next-Generation Rapid and Alternative Methods
Review the New PDA Technical Report #33 Recommendations for Demonstrating Comparability between CFU and Non-CFU Methods and How to Establish Acceptance Levels Based on the New Signal
Case Study: Usage of BWT’s AquaSense
Introduction to AquaSense (BWT)
Methodology and Detection Principle
Results of the Evaluation and Validation
Attempt to Explain Elevated Bacterial Count Findings
Discussion Regarding Potential Use in Plant Monitoring
Validation of Alternative Methods for Microbiological Examination of Water
Count of all living Microorganisms including VBNC
Online Bioburden Monitoring in Near Real Time
Validation for Intended Use
Regulatory Requirements
Undetected until Too Late: Case Studies of Contamination in Pharmaceutical Water Systems without Microbial Online Monitoring
Major Microbiological Risks in Pharmaceutical Water Systems
Biofilm Formation and the Underestimated Relevance of Gram-Negative Bioburden Findings
Case Studies of Microbial Contamination Events
The Role and Importance of Online Monitoring as an Early Warning System
Operational Impact and ROI of Microbial Online Monitoring
Microorganisms Can Swim, but They Can’t Hide: The Detection of Microbial Excursions Using a Biofluorescent Particle Counter
Introduction to the BFPC technology
Challenges of the Conventional Method for Microbial Monitoring and Contamination Control
Case Study of RMS Adoption in a Pharmaceutical Facility
Performance Qualification of the Instrument: Establish AFU Baseline during Normal Operation
Example of Microbial Excursion Detection Using Baseline Data
Future outlook
Further Information
Technical Requirements We use Webex for our live online training courses and webinars. At https://www.gmp-compliance.org/training/online-training-technical-information you will find all the information you need to participate in our events and you can check if your system meets the necessary requirements to participate. If the installation of browser extensions is not possible due to your rights in the IT system, please contact your IT department. Webex is a standard nowadays and the necessary installation is fast and easy.
Fees (per delegate plus VAT) ECA Members EUR 1,890 APIC Members EUR 1,990 Non-ECA Members EUR 2,090 EU GMP Inspectorates EUR 1,045 The conference fee is payable in advance after receipt of invoice.
Presentations/Certificate The presentations will be made available to you prior to the Live Online Training as PDF files. After the event, you will automatically receive your certificate of participation.
Conference language The official conference language will be English.
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