- Current GMP and Pharmacopoeial Requirements - Engineering, Commissioning & Qualification of Pharmaceutical Water Systems - Microbiological Control of GMP Water Systems: Monitoring & Sanitisation
Target Group
This GMP course is directed at engineers and production and QA/QC staff responsible for the design, validation and operation of pharmaceutical water systems, as well as system suppliers.
Objectives
The objective of this course is to enable you 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 are done today
How microbial control is achieved
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, 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
Further Information
Technical Requirements Our live online training courses and webinars are conducted using Webex. At www.gmp-compliance.org/training/online-training-technical-information you will find all necessary information for participation, including a system check to verify whether your IT environment meets the technical requirements. If the installation of browser extensions is restricted due to internal IT policies, please contact your IT department. Webex is widely used, and installation is straightforward.
Fees (per delegate, plus VAT) ECA Members EUR 1,890 APIC Members EUR 1,990 Non-ECA Members EUR 2,090 EU GMP Inspectorates EUR 1,045 The conference fee is payable in advance upon receipt of invoice.
Presentations/Certificate The presentations for this event will be available for you to download and print before and after the event. After the event, you will automatically receive your certificate of participation.
Conference language The official conference language will be English.
You cannot attend the Live Event? Many of the training courses and conferences are also available as recordings. You may watch these any time “on demand” on our web server. It is uncomplicated and doesn’t require any software – you simply watch the videos in your browser. All available recorded events can be found at www.gmp-compliance.org/recordings.
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