Pharmaceutical Water

Pharmaceutical Water

Berlin, Germany

Course No 9200


Costs

This conference already took place.

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

Speakers

Anthony Bevilacqua
Mettler-Toledo-Thornton, USA
Stephan Löw
Novartis, Germany
Markus Multhauf
Freelance GMP Engineer, Germany
Dr Alexander Sterchi
F.Hoffmann-La Roche, Switzerland

Objectives

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

Background

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 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.

Programme

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

Required measurements in a pharmaceutical water system
Instrumentation and monitoring for modern pharmaceutical water systems
Purpose and implementation of non-critical measurements for real-time process control
Critical measurements such as temperature, TOC, Conductivity, pressure, flow, ozone
Current requirements in global Pharmacopoeias
Evaluation of on-line vs. off-line measurement technologies for high purity water process control
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

Commissioning & Qualification of water systems (DQ-PQ)
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
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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