Pharmaceutical Water - Manufacture, Monitoring & Compliance
Im Auftrag der ECA Academy

Pharmaceutical Water - Manufacture, Monitoring & Compliance Im Auftrag der ECA Academy

Vienna, Austria

Seminar Nr. 16794


Kosten

Non-ECA Members: EUR 1690,--
ECA Members: EUR 1490,--
EU GMP Inspectorates: EUR 845,--
APIC Members (does not include ECA membership): EUR 1590,--

Alle Preise zzgl. MwSt.

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

Sprecher

Anthony Bevilacqua, Mettler-Toledo-Thornton, USA

Stephan Löw, CSL Behring, Germany

Markus Multhauf, Senior Consultant GMP Engineering, Germany

Fritz Röder, Merck

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.

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
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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