Pharmaceutical Water - Live Online Training Generation, Monitoring & Compliance

Pharmaceutical Water - Live Online Training

Course No 21620

This course is part of the GMP Certification Programme "ECA Certified Technical Operations Manager". Learn more.



ECA-Member*: EUR 1490,--
Non ECA Member*: EUR 1690,--
EU/GMP Inspectorates*: EUR 845,--
APIC Member Discount*: EUR 1590,--

(All prices excl. VAT). Important notes on sales tax.

* also payable by credit card American Express Visa Mastercard

If you have any questions, please contact us:
Tel.: +49 (0)6221 / 84 44 0 E-Mail:


Dr Anthony Bevilacqua, Mettler-Toledo-Thornton, USA
Jesper Hjorth, Novo Nordisk, Denmark
Stephan Löw, CSL Behring, Germany
Markus Multhauf, Senior Consultant GMP Engineering, Germany


The objective of this intensive education course is to enable the participants to pay optimal attention to critical issues during design, qualification and routine operation of pharmaceutical water systems.
You will learn:
  • How to meet the pharmacopoeial requirements
  • How to find the critical design aspects in a water System
  • How to generate pharmaceutical water and steam in the desired Quality
  • How commissioning and qualification is done today
  • How microbial validation and control is achieved
  • How the system is maintained in a controlled status during its life cyclefe cycle


Water is one of the most important raw materials in the manufacture of pharmaceutical products. In order to produce water of an appropriate quality, water systems have to fulfil considerable requirements, which are partly set out in detail in the relevant pharmaceutical regulations. Although the characteristics of pharmaceutical waters are sufficiently defined, a large number of questions remain unanswered as regards to the technical implementation of these bodies of regulations in GMP-conform water systems.
The main focus of the course ‘Pharmaceutical Water’ is therefore on how to put these requirements into practice. In their lectures, experienced specialists will give you important information and support for your own projects and systems, ranging from regulatory requirements, design, qualification, validation and routine operation.

Target Group

This GMP course is directed at engineers, production and QA/QC staff, responsible for design, validation and operation of pharmaceutical water systems as well as system suppliers and design engineers.

Technical Requirements

We use Webex for our live online training Courses and webinars. At 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.


Overview of Global Pharmacopoeial Requirements and Recent Changes for Pharmaceutical Waters
  • Current GMP trends and Pharmacopoeial requirements for pharmaceutical Waters
    - Requirements for Bulk Pharmaceutical Waters – Purified Water, WFI and Pure Steam
    - Requirements for Sterile and packaged Pharmaceutical Waters
  • Harmonisation and future requirements of the U.S., European, and Japanese Pharmacopoeias
State-of-the-art Pharmaceutical Water Generation
During the planning of a pharmaceutical water generation plant the influence of the feed water is often underestimated. A reliable and economically feasible system is only obtainable under consideration of the unique feed water chemistry. The Engineering phase of the project serves to make the important decisions regarding choice of technology, such as double pass RO vs. RO combined with electrodeionization.
  • Overview of different water treatment technologies and their suitability for pharmaceutical applications
  • PW and HPW generation with membrane processes (RO/EDI)
  • WFI generation with and without distillation
  • Pure Steam Generation
Water Storage and Distribution
  • Engineering Details
    - Water storage / water Distribution
  • Conception of Loops
  • Quality attributes to measure in the loop
  • Sampling issues
Modern Sanitisation Concepts
  • Sanitisation with heat
  • Sanitisation with chemicals (incl. Ozone)
  • Combination of different Methods
  • Sanitisation cycles
  • Sanitisation after breakdown and deviations
What you need to know: Stainless Steel: Piping and Equipment
  • Composition and properties of stainless steels for water and steam Systems
  • Surfaces of stainless steels and their Treatment
  • GMP-compliant welding of piping Systems
  • Rouging of stainless steels: current understanding and strategies to deal with connections, heat exchangers, valves & pumps
  • Documentation and material certificates
Technical Specialities during the Qualification of Water Systems
  • Risk-based approach to validation of a pharmaceutical water System
  • Critical components and Parameters
  • Modern qualification and commissioning
  • Package Unit Approach
  • Critical timelines
Microbiological Control of Water Systems
  • Common microbial inhabitants of pharmaceutical water Systems
  • Definition of ‘objectionable organisms’ as Pseudomonas
  • Sources of contamination and Biofilms
  • Microbiological aspects of pharmaceutical water System Validation
  • The three qualification phases
  • Routine microbiological monitoring (sampling frequency and Locations)
  • Review, interpretation and reporting of microbiological data
  • Handling OOS results in pharmaceutical water systems
GMP-compliant Operation of a pharmaceutical Water System
  • Handling of deviations and changes (examples)
  • Operating data, periodic review and revalidation
  • Maintenance and calibration
  • GMP-compliant log book handling

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