Pharmaceutical Water - Guidelines and Practice

Knowledge about pharmaceutical water systems tends to take a back seat within pharmaceutical companies. This interactive training has been set up with the aim of giving participants a solid basic knowledge of this subject.

Duration
1 day
Course fee
€ 795 (excl. VAT)

Short description

In this course the new guidelines of the European Pharmacopoeia as well as the requirements of the FDA are covered. Topics include:

  • Regulations and guidelines (Europe, United States)
  • Differences in water quality within a pharmaceutical production environment
  • Differences between RO water, PW and WFI, (Reversed Osmosis, Purified Water and Water for Injection)
  • Monitoring and testing of the water flow
  • Trend analysis,
  • Test plans in the form of a workshop
  • V-model for the qualification of a new water system

The new guidelines offer the possibility to make and use not only warm WFI but also cold WFI in Europe. During the training this matter will be discussed in further detail. In addition, the distillation process is explained.

Another interesting part of the training is that we will be looking at a WFI production system with explanation of the various components, allowing you to see from closeby how it all works. In the course of this interactive training participants are actively involved in the various subjects. There is plenty of opportunity to ask questions from the perspective of your own professional role or work situation.

Objectives

  • Acquire basic knowledge of the unit operations for water systems
  • Be aware of the requirements from Europe and the United States regarding WFI systems
  • Gain insight into how to implement cold WFI
  • Gain knowledge of qualification processes and monitoring of a WFI system
  • Understand the different steps in the preparation of WFI
  • Know the difference between WFI in bulk and in bottles

Target group

  • QA staff and QA auditors who want to know more about the background of water systems
  • Technical staff responsible for water systems
  • Consultants who want to gain a basic knowledge of water systems

Program

Day 1

 

Guidelines for pharmaceutical water

• What are the requirements for the quality of the water used for various types of pharmaceutical products?
• What is RO, PW and WFI?
• Various unit operations for preparing WFI
• EMA: Application of RO for production of WFI
• Acceptance criteria and analytical method for PW and WFI according to Ph.Eur. and USP

 

Qualification when purchasing new water systems or adaptations to the water system

• Design qualification
• Installation qualification
• Operation qualification
• Process qualification (WHO and USP guidelines)

 

WFI Monitoring

• Test methods and acceptance criteria
• Test frequency
• Trend analyses
• Which actions should be performed if monitoring results are out of specification

 

Workshop "WFI: make your own sampling scheme".

Preparation of a monitoring plan based on a technical drawing of a water system.

 

Cold WFI

• Regulatory changes
• Equipment design possibilities for cold WFI

 

Distillation process

• Single Effect Still (SE)
• Multi-Effect Still(ME)
• Vapor Compression (VC)
• WFI system: Tour/Demonstration

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Interested in signing up a group of people for this course?

Please contact our Business Development team:
info@biotechtrainingfacility.nl
+31 (0)88 2830100

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Need help? Have a question or a suggestion maybe?

Drop us a line below or call us on
+31 (0) 88 283 01 00.

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