Dr Anthony Bevilacqua, Mettler-Toledo-Thornton, USA
Stephan Löw, CSL Behring, Germany
Markus Multhauf, Senior Consultant GMP Engineering, Germany
Fritz Röder, Merck, 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 systems is maintained in a controlled Status during its life 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.
This GMP course is directed to engineers, production and QA/QC staff, responsible for design, validation and operation of pharmaceutical water systems as well as system suppliers and design engineers.
To participate in an on demand training course or webinar, you do not need any software. The recordings are made available via a streaming server. In general, the recording is provided in MP4 format, which any PC (Microsoft Windows, Apple IOS) or tablet can easily display.
Timing and Duration:
When you register for the on demand Training course or webinar you can decide at what date you want to follow the training course online. For a 1-day training course you will have 2 days in which the stream is available (for 2-day training course 3 days and for a 3-day training course 4 days). Within in this timeframe you can start & stop the stream according to your needs.
In time before the scheduled date (your desired date) you will receive an e-mail from us with a link for direct participation as well as your log-in data.
Please be aware: The recording does not include the Q & A sessions.
Training Course Documentation and Certificate:
The presentations will be made available as PDF files via download shortly before the online training course. After the event, you will automatically receive your certificate of participation.
Overview of Global Pharmacopoeial Requirementsand Recent Changes for Pharmaceutical Waters
- Current GMP trends and Pharmacopoeial requirements for pharmaceutical Waters
- Requirements for Bulk Pharmaceutical Waters - Purified Water, Highly 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. Another question for pharmaceutical manufacturers arises from the EMEA: is the use of Highly Purified Water or treatment with Reverse Osmosis for generation of WFI quality acceptable?
- Overview of different water treatment technologies and their suitability for pharmaceutical applications
- PW and HPW generation with membrane processes (RO/EDI)
- WFI generation with 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
- From qualification to routine operation
- Handling of deviations and changes
- Review of operating data
- Maintenance and Calibration
- Calibration cycles
- GMP-compliant log book handling
- The Water system in the Product Quality Review (PQR)
Recording from 17/18 May 2022
Duration of the recording: approx. 9.5 hours