Live Online Training - Pharmaceutical Water
Im Auftrag der ECA Academy

1/2 December 2020

Seminar Nr. 18428

Unser Seminarservice

Kosten

Für dieses Online Training ist keine Aufzeichnung verfügbar. Habe Sie Interesse an einem kommenden Termin dieses Live Online Trainings teilzunehmen? Wünschen Sie individuelle Beratung zu unserem Schulungsangebot? Dann kontaktieren Sie uns.

Anfrage stellen

Rückfragen unter:
Tel.: 06221 / 84 44 0 E-Mail: info@concept-heidelberg.de

Sprecher

Dr Anthony Bevilacqua, Mettler-Toledo-Th ornton, USA
Stephan Löw, CSL Behring, Germany
Markus Multhauf, Senior Consultant GMP Engineering, Germany
Fritz Röder, Merck, Germany

Zielsetzung

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

Hintergrund

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.

Zielgruppe

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.

Technical Requirements

For our webinars, we use Cisco WebEx, one of the leading suppliers of online meetings. At http://www.webex.com/test-meeting.html you can check if your system meets the necessary requirements for the participation at a WebEx meeting and at the same time install the necessary plug-in. Please just enter your Name and e-mail address for the test. If the installation is not possible because of your rights for the computer system, please contact your IT department. WebEx is a standard nowadays and the necessary installation is fast and easy.

Programm

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, 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)

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Live Online Training - Pharmaceutical WaterIm Auftrag der ECA Academy