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 system is maintained in a controlled status during its life cyclefe 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 at 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
We use Webex for our live online training courses and webinars. At www.gmp-compliance.org/training/online-trainingtechnical-information you will find all the information you need to participate in our events and you can check if your system meets the necessary requirements to participate. If the installation of browser extensions is not possible due to your rights in the IT system, please contact your IT department. Webex is a standard nowadays and the necessary installation is fast and easy.
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, 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.
Overview of different water treatment technologies and their suitability for pharmaceutical applications
PW and HPW generation with membrane processes (RO/EDI)
WFI generation with and without 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
Handling of deviations and changes (examples)
Operating data, periodic review and revalidation
Maintenance and calibration
GMP-compliant log book handling
This course is part of the GMP Certification Programme "ECA Certified Technical Operations Manager" Learn more
Testimonials
Seminar Programme as PDF